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| ID | Type | Description | Link |
|---|---|---|---|
| I01RX000130 | U.S. NIH Grant/Contract | View source |
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This study will determine the type and combination of exercise needed to rehabilitate the neuro-compromised diabetic Veteran. Guided exercise protocols may prove to be practical therapeutic options for the prophylactic management of diabetic subjects with neuropathy.
Purpose: A single-site, randomized, blinded, prospective clinical trial is proposed to determine the significance of a combined isokinetic strength and aerobic exercise training program on the rehabilitation of peripheral nerve function in Type 2 diabetic veterans and non-veterans with neuropathy. Background and Significance: Obesity is a major factor in the increasing rates of diabetes and its related complications. Diabetes affects greater than 7% of the population. Veterans are at even greater risk, with approximately 16% currently receiving treatment at Department of Veterans Affairs Medical Centers for diabetes. More than half of affected veterans experience debilitating complications of diabetes, including peripheral neuropathy (PN). Exercise training, in combination with pharmacologic intervention, is now recognized as a cornerstone of management for diabetes. Therapeutic interventions currently available for the treatment of PN in diabetic patients are limited, however, to pain management and stringent glycemic control. Exercise is reported to significantly decrease peripheral nerve microvascular complications common among chronic diabetics. Our preliminary findings demonstrate that exercise intervention improves peripheral nerve function in the diabetic veteran with PN. Intervention strategies, such as proposed in this application, offer a unique and novel therapeutic option for the rehabilitation of the neuro-compromised Type 2 diabetic veterans and non-veterans. Methods & Research Plan: One-hundred subjects will be recruited for this 24-week study. Subjects each will be randomly assigned to aerobic, isokinetic strength training, combined aerobic and strength training, or non-exercise (control) intervention groups. Isokinetic strength training (Biodex System 3), aerobic exercise training (treadmill), or the combination of strength and aerobic training will be administered 3x per week for the initial 12 weeks. Control subjects will receive 12 clinical visits over the course of the initial 12 weeks. The effects of exercise training type, compared with control subjects, on recovery of peripheral nerve function will be rigorously determined from baseline, 12- and 24-week testing using electrodiagnostic primary outcome measures, Quantitative Sensory Testing, and a battery of validated qualitative and quantitative secondary outcome measures that include an incremental symptom-limited treadmill test, peak torque, Total Neuropathy Score, visual analogue pain scale, and quality of life SF-36V Health Survey. Sustainability of effect will be determined at 24-weeks.The individual effects of exercise training type, compared with control subjects, on tissue oxygenation will be determined from baseline, 12- and 24-week testing by non-invasive quantitated infrared spectroscopy using an InSpectraTM Tissue Spectrometer. Expected Outcomes: This study will objectively and critically determine the type and combination of exercise needed to rehabilitate the neuro-compromised diabetic Veteran. Guided exercise protocols may prove to be practical therapeutic options for the prophylactic management of diabetic subjects with neuropathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | No Intervention | Sedentary Control Group | |
| Arm 2 | Experimental | Aerobic Exercise Group |
|
| Arm 3 | Experimental | Isokinetic Strength Exercise Group |
|
| Arm 4 | Experimental | Combined Aerobic and Isokinetic Strength Exercise Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | Structured aerobic exercise (treadmill). |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Sural Nerve Amplitude | Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. | Baseline, 12, and 24 weeks |
| Sural Nerve Latency | Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. | Baseline, 12 wks, 24 wks |
| Sural Nerve Conduction Velocity | Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom-Limited TMT Blood Glucose Response | Changes in blood glucose in response to modified Bruce Protocol treadmill test (TMT) | Initial entry into study, 12 and 24 weeks |
| Short Form-36V: Physical Component Score |
| Measure | Description | Time Frame |
|---|---|---|
| Height | Height of subjects upon entry into study | baseline |
| Weight | Weight of subjects at baseline, 12-weeks, and 24-weeks | Baseline, 12-wks, 24-wks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evan Stubbs | Edward Hines Jr. VA Hospital, Hines, IL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edward Hines Jr. VA Hospital, Hines, IL | Hines | Illinois | 60141-5000 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30804739 | Derived | Stubbs EB Jr, Fisher MA, Miller CM, Jelinek C, Butler J, McBurney C, Collins EG. Randomized Controlled Trial of Physical Exercise in Diabetic Veterans With Length-Dependent Distal Symmetric Polyneuropathy. Front Neurosci. 2019 Feb 11;13:51. doi: 10.3389/fnins.2019.00051. eCollection 2019. |
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Prior to group randomization, all consenting subjects underwent two separate symptom-limited treadmill stress tests to unmask potentially life-threatening indolent cardiac and/or respiratory disease limitations
Edward Hines Jr. VA Hospital from January 2010-May 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sedentary | Sedentary Control Group |
| FG001 | Aerobic Exercise | Structured aerobic exercise (treadmill). |
| FG002 | Strength Exercise | Structured isokinetic strength exercise (dynameter). |
| FG003 | Combined Aerobic and Strength | Structured aerobic exercise (treadmill) plus structured isokinetic strength exercise (dynameter). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Population studied are US Veterans and civilians diagnosed with long-standing (9-13y) type 2 diabetes mellitus with length-dependent distal polyneuropathy. Subjects were randomly assigned to either Sedentary, Aerobic Exercise, Strength Exercise, or a combination of Aerobic and Strength Exercise using "Research Randomizer" in blocks of 8.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sedentary | Sedentary Control Group |
| BG001 | Aerobic Exercise | Structured aerobic exercise (treadmill). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sural Nerve Amplitude | Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. | Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation. Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders. | Posted | Mean | Standard Deviation | uV | Baseline, 12, and 24 weeks |
5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sedentary | Sedentary Control Group | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 4 years 6 months | Surgical and medical procedures | Non-systematic Assessment |
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Chronic type 2 diabetic patient population with advanced complications, including peripheral neuropathy, presented with unanticipated highly variable baseline measures that markedly diminished the studies statistical power.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Evan Stubbs | Edward Hines Jr. VA Hospital | 708-202-3507 | evan.stubbs@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Oct 1, 2009 | Feb 13, 2019 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Exercise |
| Behavioral |
Structured isokinetic strength exercise (dynameter). |
|
| Baseline, 12 wks, 24 wks |
| Tibial Nerve Amplitude | Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. | Baseline, 12 weeks, 24 weeks |
| Tibial Nerve Latency | Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. | Baseline, 12 weeks, 24 weeks |
| Tibial Nerve Conduction Velocity | Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. | Baseline, 12 weeks, 24 weeks |
| Sensory Median Nerve Amplitude | Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. | Baseline, 12, and 24 weeks |
| Sensory Median Nerve Latency | Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. | Baseline, 12wks, 24 wks |
| Sensory Median Nerve Conduction Velocity | Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. | Baseline, 12 wks, 24 wks |
| Sensory Ulnar Nerve Amplitude | Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. | Baseline, 12 wks, 24 wks |
| Sensory Ulnar Nerve Latency | Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. | Baseline, 12 wks, 24 wks |
| Sensory Ulnar Nerve Conduction Velocity | Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. | Baseline, 12 wks, 24 wks |
| Peroneal Nerve Amplitude | Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. | Baseline, 12 wks, 24 wks |
| Peroneal Nerve Latency | Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. | Baseline, 12 wks, 24 wks |
| Peroneal Nerve Conduction Velocity | Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. | Baseline, 12 wks, 24 wks |
The short form-36Veterans (SF-36V) health survey questionnaire was used to measure health-related quality of life. This survey is comprised of eight subscales and two overall component scores, all of which have demonstrated high levels of internal consistency and discriminate validity when administered to groups of medically stable individuals. Patient aggregate responses for the eight distinct summary subscales and two component scores were compiled as a percentage of total points possible using the RAND 36-item health survey table. Data shown are expressed as a percentage of total possible score ranging from 0%-100% with 100% considered relatively good health and 0% considered poor health. Physical Component scores reflect perceived changes in physical health relative to the previous year.
| Initial entry into study, 12 and 24 weeks |
| Voluntary Duration of Symptom-Limited TMT | Total time subjects voluntarily exercised while undergoing a modified Bruce Protocol treadmill test (TMT) | baseline, 12-wks, 24-wks |
| Symptom-Limited TMT Maximum Heart Rate | Peak heart rate achieved while undergoing a modified Bruce Protocol treadmill test (TMT) | baseline, 12-wks, 24-wks |
| Symptom-Limited TMT Maximum Systolic Blood Pressure | Peak systolic BP achieved while undergoing a modified Bruce Protocol treadmill test (TMT) | Baseline, 12-wk, 24-wk |
| Symptom-Limited TMT Maximum Minute Ventilation (VE) | Peak volume of air exchanged per minute achieved while undergoing a modified Bruce Protocol treadmill test (TMT) | Baseline, 12-wks, 24-wks |
| Symptom-Limited TMT Maximum Oxygen Uptake (VO2) | Peak Oxygen uptake achieved while undergoing a modified Bruce Protocol treadmill test (TMT) | Baseline, 12-wks, 24-wks |
| Maximum Respiratory Exchange Ratio (RER) During TMT | Peak RER achieved while undergoing a modified Bruce Protocol treadmill test (TMT). This is a mathematical ratio of maximally achieved (peak) VCO2 divided by maximally achieved (peak) VO2. | Baseline, 12-wks, 24-wks |
| Symptom-Limited TMT Maximum Carbon Dioxide Expelled (VCO2) | Peak Carbon Dioxide expelled achieved while undergoing a modified Bruce Protocol treadmill test (TMT) | Baseline, 12-wks, 24-wks |
| Symptom-Limited TMT Maximum METS Achieved (MET) | Peak metabolic rate equivalents (METS) achieved while undergoing a modified Bruce Protocol treadmill test (TMT). One MET is defined as the metabolic rate observed at rest, quantified as resting oxygen consumption of 250 ml/min (Male) or 200 ml /min (female). A value of 5 METS would represent a metabolic rate that is 5x that at rest and is considered an indicator of how hard a given individual is exercising. Data shown are expressed as a ratio at peak of exercise of oxygen consumed relative to normalized values for men or women at rest. | Baseline, 12-wks, 24-wks |
| Short Form-36V: Mental Component Score | The short form-36Veterans (SF-36V) health survey questionnaire was used to measure health-related quality of life. This survey is comprised of eight subscales and two overall component scores, all of which have demonstrated high levels of internal consistency and discriminate validity when administered to groups of medically stable individuals. Patient aggregate responses for the eight distinct summary subscales and two component scores were compiled as a percentage of total points possible using the RAND 36-item health survey table. Data shown are expressed as a percentage of total possible score ranging from 0%-100% with 100% considered relatively good health and 0% considered poor health. Mental Component scores reflect perceived changes in emotional health relative to the previous year. | initial entry into study, and at 12-wks and 24-wks |
| Body Mass Index (BMI) | BMI is calculated as a ratio of subject body mass (kg) divided by the square of subject height (m). | Baseline, 12-wk, 24-wk |
| Duration of Diabetes Mellitus | Duration, in years, since first diagnosed with Diabetes Mellitus upon entry into study | Baseline |
| HbA1C Laboratory Values | Laboratory values of subject HbA1C levels at Baseline, 12-wk, 24-wk | Baseline, 12-wk, 24-wk |
| Triglyceride Laboratory Values | Laboratory triglyceride values at baseline entry into study | Baseline |
| Cholesterol Laboratory Values | Laboratory total cholesterol, HDL-cholesterol, and LDL-cholesterol levels at baseline entry into study | Baseline |
| Creatinine Laboratory Values | Laboratory creatinine values at baseline entry into study | Baseline |
| Blood Urea Nitrogen (BUN) Laboratory Values | Laboratory Blood Urea Nitrogen levels at baseline entry into study | Baseline |
| Aspartate Aminotransferase Laboratory Values | Laboratory values for Aspartate Aminotransferase (AST) at baseline entry into study | Baseline |
| Thyroid Stimulating Hormone Laboratory Values | Laboratory values for Thyroid Stimulating Hormone (TSH) at baseline entry into study | Baseline |
| Age | Age of participants at entry into study. | at baseline |
| BG002 |
| Strength Exercise |
Structured isokinetic strength exercise (dynameter). |
| BG003 | Combined Aerobic and Strength | Structured aerobic exercise (treadmill).plus structured isokinetic strength exercise (dynameter). |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | Count of Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Sedentary Control Group | Sedentary Control Group |
| OG001 | Aerobic Exercise Group | Aerobic Exercise Group Exercise: Structured aerobic exercise (treadmill). |
| OG002 | Strength Exercise Group | Strength Exercise Group Exercise: Structured isokinetic strength exercise (dynameter). |
| OG003 | Combined Aerobic and Strength Exercise Group | Combined Aerobic and Isokinetic Strength Exercise Group Exercise: Structured aerobic exercise (treadmill). Exercise: Structured isokinetic strength exercise (dynameter). |
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| Primary | Sural Nerve Latency | Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. | Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders. | Posted | Mean | Standard Deviation | ms | Baseline, 12 wks, 24 wks |
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| Primary | Sural Nerve Conduction Velocity | Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. | Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders. | Posted | Mean | Standard Deviation | m/s | Baseline, 12 wks, 24 wks |
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| Primary | Tibial Nerve Amplitude | Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. | Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders. | Posted | Mean | Standard Deviation | mV | Baseline, 12 weeks, 24 weeks |
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| Primary | Tibial Nerve Latency | Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. | Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders. | Posted | Mean | Standard Deviation | ms | Baseline, 12 weeks, 24 weeks |
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| Primary | Tibial Nerve Conduction Velocity | Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. | Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders. | Posted | Mean | Standard Deviation | m/s | Baseline, 12 weeks, 24 weeks |
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| Primary | Sensory Median Nerve Amplitude | Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. | Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders. | Posted | Mean | Standard Deviation | uV | Baseline, 12, and 24 weeks |
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| Primary | Sensory Median Nerve Latency | Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. | Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders. | Posted | Mean | Standard Deviation | ms | Baseline, 12wks, 24 wks |
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| Primary | Sensory Median Nerve Conduction Velocity | Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. | Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders. | Posted | Mean | Standard Deviation | m/s | Baseline, 12 wks, 24 wks |
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| Primary | Sensory Ulnar Nerve Amplitude | Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. | Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders. | Posted | Mean | Standard Deviation | uV | Baseline, 12 wks, 24 wks |
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| Primary | Sensory Ulnar Nerve Latency | Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. | Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders. | Posted | Mean | Standard Deviation | ms | Baseline, 12 wks, 24 wks |
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| Primary | Sensory Ulnar Nerve Conduction Velocity | Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. | Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders. | Posted | Mean | Standard Deviation | m/s | Baseline, 12 wks, 24 wks |
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| Primary | Peroneal Nerve Amplitude | Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. | Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders. | Posted | Mean | Standard Deviation | mV | Baseline, 12 wks, 24 wks |
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| Primary | Peroneal Nerve Latency | Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. | Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 7 at 6 month evaluation. Data shown include responders and non-responders. | Posted | Mean | Standard Deviation | ms | Baseline, 12 wks, 24 wks |
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| Primary | Peroneal Nerve Conduction Velocity | Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies. | Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 1) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. No data recorded for 1 Sedentary subject at 3 month evaluation. Data shown include responders and non-responders. | Posted | Mean | Standard Deviation | m/s | Baseline, 12 wks, 24 wks |
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| Secondary | Symptom-Limited TMT Blood Glucose Response | Changes in blood glucose in response to modified Bruce Protocol treadmill test (TMT) | Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#1) eval. Subj. withdrawn from study by PI/co-PI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) post 24 week EMG and withdrawn s/p hosp. | Posted | Mean | Standard Deviation | mg/dl | Initial entry into study, 12 and 24 weeks |
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| Secondary | Short Form-36V: Physical Component Score | The short form-36Veterans (SF-36V) health survey questionnaire was used to measure health-related quality of life. This survey is comprised of eight subscales and two overall component scores, all of which have demonstrated high levels of internal consistency and discriminate validity when administered to groups of medically stable individuals. Patient aggregate responses for the eight distinct summary subscales and two component scores were compiled as a percentage of total points possible using the RAND 36-item health survey table. Data shown are expressed as a percentage of total possible score ranging from 0%-100% with 100% considered relatively good health and 0% considered poor health. Physical Component scores reflect perceived changes in physical health relative to the previous year. | Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#1) eval. Subj. withdrawn from study by PI/coPI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) post 24 week EMG and withdrawn s/p hosp. | Posted | Mean | Standard Deviation | score on a scale | Initial entry into study, 12 and 24 weeks |
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| Secondary | Voluntary Duration of Symptom-Limited TMT | Total time subjects voluntarily exercised while undergoing a modified Bruce Protocol treadmill test (TMT) | Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#2) eval. Subj. withdrawn from study by PI/coPI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) fell post 24 week EMG and withdrawn s/p hosp. | Posted | Mean | Standard Deviation | minutes | baseline, 12-wks, 24-wks |
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| Secondary | Symptom-Limited TMT Maximum Heart Rate | Peak heart rate achieved while undergoing a modified Bruce Protocol treadmill test (TMT) | Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#2) eval. Subj. withdrawn from study by PI/coPI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) fell post 24 week EMG and withdrawn s/p hosp. | Posted | Mean | Standard Deviation | beats per min | baseline, 12-wks, 24-wks |
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| Secondary | Symptom-Limited TMT Maximum Systolic Blood Pressure | Peak systolic BP achieved while undergoing a modified Bruce Protocol treadmill test (TMT) | Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#2) eval. Subj. withdrawn from study by PI/coPI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) fell post 24 week EMG and withdrawn s/p hosp. | Posted | Mean | Standard Deviation | mmHg | Baseline, 12-wk, 24-wk |
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| Secondary | Symptom-Limited TMT Maximum Minute Ventilation (VE) | Peak volume of air exchanged per minute achieved while undergoing a modified Bruce Protocol treadmill test (TMT) | Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#2) eval. Subj. withdrawn from study by PI/coPI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) fell post 24 week EMG and withdrawn s/p hosp. | Posted | Mean | Standard Deviation | liters/min | Baseline, 12-wks, 24-wks |
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| Secondary | Symptom-Limited TMT Maximum Oxygen Uptake (VO2) | Peak Oxygen uptake achieved while undergoing a modified Bruce Protocol treadmill test (TMT) | Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#2) eval. Subj. withdrawn from study by PI/coPI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) fell post 24 week EMG and withdrawn s/p hosp. | Posted | Mean | Standard Deviation | ml/min/kg | Baseline, 12-wks, 24-wks |
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| Secondary | Maximum Respiratory Exchange Ratio (RER) During TMT | Peak RER achieved while undergoing a modified Bruce Protocol treadmill test (TMT). This is a mathematical ratio of maximally achieved (peak) VCO2 divided by maximally achieved (peak) VO2. | Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#2) eval. Subj. withdrawn from study by PI/coPI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) post 24 week EMG and withdrawn s/p hosp. | Posted | Mean | Standard Deviation | ratio | Baseline, 12-wks, 24-wks |
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| Secondary | Symptom-Limited TMT Maximum Carbon Dioxide Expelled (VCO2) | Peak Carbon Dioxide expelled achieved while undergoing a modified Bruce Protocol treadmill test (TMT) | Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#2) eval. Subj. withdrawn from study by PI/coPI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) fell post 24 week EMG and withdrawn s/p hosp. | Posted | Mean | Standard Deviation | ml/min/kg | Baseline, 12-wks, 24-wks |
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| Secondary | Symptom-Limited TMT Maximum METS Achieved (MET) | Peak metabolic rate equivalents (METS) achieved while undergoing a modified Bruce Protocol treadmill test (TMT). One MET is defined as the metabolic rate observed at rest, quantified as resting oxygen consumption of 250 ml/min (Male) or 200 ml /min (female). A value of 5 METS would represent a metabolic rate that is 5x that at rest and is considered an indicator of how hard a given individual is exercising. Data shown are expressed as a ratio at peak of exercise of oxygen consumed relative to normalized values for men or women at rest. | Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#2) eval. Subj. withdrawn from study by PI/coPI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) fell post 24 week EMG and withdrawn s/p hosp. | Posted | Mean | Standard Deviation | ratio | Baseline, 12-wks, 24-wks |
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| Secondary | Short Form-36V: Mental Component Score | The short form-36Veterans (SF-36V) health survey questionnaire was used to measure health-related quality of life. This survey is comprised of eight subscales and two overall component scores, all of which have demonstrated high levels of internal consistency and discriminate validity when administered to groups of medically stable individuals. Patient aggregate responses for the eight distinct summary subscales and two component scores were compiled as a percentage of total points possible using the RAND 36-item health survey table. Data shown are expressed as a percentage of total possible score ranging from 0%-100% with 100% considered relatively good health and 0% considered poor health. Mental Component scores reflect perceived changes in emotional health relative to the previous year. | Subj. withdrew from study prior to 3 mo. (#3) and 6 mo. (#1) eval. Subj. withdrawn from study by PI/coPI prior to 3 month (#2) and 6 month (#1) eval. Total difference = 8 at 6 mo. eval. 1(Sed) had EMG @ 12 and 24 wks didn't receive clearance for TMT but to continue in other study activities. 1 (Sed) post 24 week EMG and withdrawn s/p hosp. | Posted | Mean | Standard Deviation | score on a scale | initial entry into study, and at 12-wks and 24-wks |
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| Other Pre-specified | Height | Height of subjects upon entry into study | Posted | Mean | Standard Deviation | cm | baseline |
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| Other Pre-specified | Weight | Weight of subjects at baseline, 12-weeks, and 24-weeks | Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 2) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 8 at 6 month evaluation. | Posted | Mean | Standard Deviation | kg | Baseline, 12-wks, 24-wks |
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| Other Pre-specified | Body Mass Index (BMI) | BMI is calculated as a ratio of subject body mass (kg) divided by the square of subject height (m). | Subjects withdrew from study prior to 3 month (# 3) and 6 month (# 2) evaluation Subjects were withdrawn from study by principal/ co-principal investigator prior to 3 month (# 2) and 6 month (# 1) evaluation. Total difference = 8 at 6 month evaluation. | Posted | Mean | Standard Deviation | kg/m^2 | Baseline, 12-wk, 24-wk |
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| Other Pre-specified | Duration of Diabetes Mellitus | Duration, in years, since first diagnosed with Diabetes Mellitus upon entry into study | Posted | Mean | Standard Deviation | years | Baseline |
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| Other Pre-specified | HbA1C Laboratory Values | Laboratory values of subject HbA1C levels at Baseline, 12-wk, 24-wk | A1c testing was performed prior to EMG evaluation so there are 2/4 additional values for 3/6 month numbers of subjects than is reflected in the statement regarding subject withdrawal in the EMG sections. Total difference = 6 at 6 month evaluation. | Posted | Mean | Standard Deviation | percentage of Hb | Baseline, 12-wk, 24-wk |
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| Other Pre-specified | Triglyceride Laboratory Values | Laboratory triglyceride values at baseline entry into study | Posted | Mean | Standard Deviation | mg/dL | Baseline |
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| Other Pre-specified | Cholesterol Laboratory Values | Laboratory total cholesterol, HDL-cholesterol, and LDL-cholesterol levels at baseline entry into study | Posted | Mean | Standard Deviation | mg/dL | Baseline |
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| Other Pre-specified | Creatinine Laboratory Values | Laboratory creatinine values at baseline entry into study | Posted | Mean | Standard Deviation | mg/dL | Baseline |
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| Other Pre-specified | Blood Urea Nitrogen (BUN) Laboratory Values | Laboratory Blood Urea Nitrogen levels at baseline entry into study | Posted | Mean | Standard Deviation | mg/dL | Baseline |
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| Other Pre-specified | Aspartate Aminotransferase Laboratory Values | Laboratory values for Aspartate Aminotransferase (AST) at baseline entry into study | Posted | Mean | Standard Deviation | units/L | Baseline |
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| Other Pre-specified | Thyroid Stimulating Hormone Laboratory Values | Laboratory values for Thyroid Stimulating Hormone (TSH) at baseline entry into study | Posted | Mean | Standard Deviation | uIU/mL | Baseline |
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| Other Pre-specified | Age | Age of participants at entry into study. | Posted | Mean | Standard Deviation | years | at baseline |
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|
| 12 |
| 6 |
| 12 |
| 0 |
| 12 |
| EG001 | Aerobic Exercise | Structured aerobic exercise (treadmill) | 4 | 11 | 4 | 11 | 0 | 11 |
| EG002 | Strength Exercise | Structured isokinetic strength exercise (dynameter). | 4 | 11 | 4 | 11 | 0 | 11 |
| EG003 | Combined Aerobic and Strength | Structured aerobic exercise (treadmill) and structured isokinetic strength exercise (dynameter). | 5 | 11 | 5 | 11 | 0 | 11 |
Not provided
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
| 12 weeks |
|
|
| 24 weeks |
|
|
| 1.00 |
Tukey's multiple comparisons test: |
| Superiority |
| Evaluated within group across time | ANOVA | 1.00 | Tukey's multiple comparisons test: | Superiority |
| Evaluated within group across time | ANOVA | 0.93 | Tukey's multiple comparisons test: | Superiority |
| Comparison across groups at baseline. | ANOVA | 0.80 | Superiority |
| Comparison across groups at 12-wks | ANOVA | 0.63 | Superiority |
| Comparison across groups at 24-wk | ANOVA | 0.31 | Superiority |
|
| 12 weeks |
|
|
| 24 weeks |
|
|
| 1.00 |
Tukey's multiple comparisons test: |
| Superiority |
| Evaluated within group across time | ANOVA | 1.00 | Tukey's multiple comparisons test: | Superiority |
| Evaluated within group across time | ANOVA | 0.98 | Tukey's multiple comparisons test: | Superiority |
| Comparison across groups at baseline | ANOVA | 0.70 | Superiority |
| Comparison across groups at 12-wks | ANOVA | 0.45 | Superiority |
| Comparison across groups at 24-wks | ANOVA | 0.22 | Superiority |
|
| 12 wks |
|
|
| 24 wks |
|
|
| 0.90 |
Tukey's multiple comparisons test: |
| Superiority |
| Evaluated within group across time | ANOVA | 0.97 | Tukey's multiple comparisons test: | Superiority |
| Evaluated within group across time | ANOVA | 0.78 | Tukey's multiple comparisons test: | Superiority |
| Comparison across groups at baseline | ANOVA | 0.63 | Superiority |
| Comparison across groups at 12-wk | ANOVA | 0.97 | Superiority |
| Comparison across groups at 24-wks | ANOVA | 0.99 | Superiority |
|
| 12 wks |
|
|
| 24 wks |
|
|
| 0.69 |
Tukey's multiple comparisons test: |
| Superiority |
| Evaluated within group across time | ANOVA | 0.98 | Tukey's multiple comparisons test: | Superiority |
| Evaluated within group across time | ANOVA | 0.97 | Tukey's multiple comparisons test: | Superiority |
| Comparison across groups at baseline | ANOVA | 0.45 | Superiority |
| Comparison across groups at 12-wks | ANOVA | 0.91 | Superiority |
| Comparison across groups at 24-wks | ANOVA | 0.51 | Superiority |
|
| 12 wks |
|
|
| 24 wks |
|
|
| 0.72 |
Tukey's multiple comparisons test: |
| Superiority |
| Evaluated within group across time | ANOVA | 0.99 | Tukey's multiple comparisons test: | Superiority |
| Evaluated within group across time | ANOVA | 0.99 | Tukey's multiple comparisons test: | Superiority |
| Comparison across groups at baseline | ANOVA | 0.85 | Superiority |
| Comparison across groups at 12-wks | ANOVA | 0.98 | Superiority |
| Comparison across groups at 24-wks | ANOVA | 0.68 | Superiority |
|
| 12 weeks |
|
|
| 24 weeks |
|
|
| 0.99 |
Tukey's multiple comparisons test: |
| Superiority |
| Evaluated within group across time | ANOVA | 0.94 | Tukey's multiple comparisons test: | Superiority |
| Evaluated within group across time | ANOVA | 0.93 | Tukey's multiple comparisons test: | Superiority |
| Comparison across groups at baseline | ANOVA | 0.38 | Superiority |
| Comparison across groups at 12-wks | ANOVA | 0.51 | Superiority |
| Comparison across groups at 24-wks | ANOVA | 0.94 | Superiority |
|
| 12 weeks |
|
|
| 24 weeks |
|
|
| 0.97 |
Tukey's multiple comparisons test: |
| Superiority |
| Evaluated within group across time. | ANOVA | 0.96 | Tukey's multiple comparisons test: | Superiority |
| Evaluated within group across time. | ANOVA | 1.00 | Tukey's multiple comparisons test: | Superiority |
| Comparison across groups at baseline. | ANOVA | 0.16 | Superiority |
| Comparison across groups at 12-wks | ANOVA | 0.37 | Superiority |
| Comparison across groups at 24-wks | ANOVA | 0.75 | Superiority |
|
| 12 weeks |
|
|
| 24 weeks |
|
|
| 0.99 |
Tukey's multiple comparisons test: |
| Superiority |
| Evaluated within group across time. | ANOVA | 1.00 | Tukey's multiple comparisons test: | Superiority |
| Evaluated within group across time. | ANOVA | 0.81 | Tukey's multiple comparisons test: | Superiority |
| Comparison across groups at baseline | ANOVA | 0.28 | Superiority |
| Comparison across groups at 12-wks | ANOVA | 0.28 | Superiority |
| Comparison across groups at 24-wks | ANOVA | 0.83 | Superiority |
|
| 12 weeks |
|
|
| 24 weeks |
|
|
| 0.97 |
Tukey's multiple comparisons test: |
| Superiority |
| Evaluated within group across time | ANOVA | 0.82 | Tukey's multiple comparisons test: | Superiority |
| Evaluated within group across time | ANOVA | 0.96 | Tukey's multiple comparisons test: | Superiority |
| Comparison across groups at baseline. | ANOVA | 0.55 | Superiority |
| Comparison across groups at 12-wks | ANOVA | 0.31 | Superiority |
| Comparison across groups at 24-wks | ANOVA | 0.32 | Superiority |
|
| 12 weeks |
|
|
| 24 weeks |
|
|
| 0.92 |
Tukey's multiple comparisons test: |
| Superiority |
| Evaluated within group across time. | ANOVA | 0.93 | Tukey's multiple comparisons test: | Superiority |
| Evaluated within group across time. | ANOVA | 0.99 | Tukey's multiple comparisons test: | Superiority |
| Comparison across groups at baseline. | ANOVA | 0.50 | Superiority |
| Comparison across groups at 12-wks. | ANOVA | 0.47 | Superiority |
| Comparison across groups at 24-wks | ANOVA | 0.97 | Superiority |
|
| 12 weeks |
|
|
| 24 weeks |
|
|
| 0.91 |
Tukey's multiple comparisons test: |
| Superiority |
| Evaluated within group across time. | ANOVA | 1.00 | Tukey's multiple comparisons test: | Superiority |
| Evaluated within group across time. | ANOVA | 0.95 | Tukey's multiple comparisons test: | Superiority |
| Comparison across groups at baseline. | ANOVA | 0.26 | Superiority |
| Comparison across groups at 12-wks | ANOVA | 0.42 | Superiority |
| Comparison across groups at 24-wks. | ANOVA | 0.95 | Superiority |
|
| 12 weeks |
|
|
| 24 weeks |
|
|
| 0.53 |
Tukey's multiple comparisons test: |
| Superiority |
| Evaluated within group across time. | ANOVA | 0.79 | Tukey's multiple comparisons test: | Superiority |
| Evaluated within group across time. | ANOVA | 0.94 | Tukey's multiple comparisons test: | Superiority |
| Comparison across groups at baseline | ANOVA | 0.75 | Superiority |
| Comparison across groups at 12-wks | ANOVA | 0.51 | Superiority |
| Comparison across groups at 24-wks. | ANOVA | 0.63 | Superiority |
|
| 12 weeks |
|
|
| 24 weeks |
|
|
| 0.99 |
Tukey's multiple comparisons test: |
| Superiority |
| Evaluated within group across time. | ANOVA | 0.89 | Tukey's multiple comparisons test: | Superiority |
| Evaluate within group across time. | ANOVA | 0.90 | Tukey's multiple comparisons test: | Superiority |
| Comparison across groups at baseline | ANOVA | 0.98 | Superiority |
| Comparison across groups at 12-wks | ANOVA | 0.94 | Superiority |
| Comparison across groups at 24-wks. | ANOVA | 0.91 | Superiority |
|
| 12 weeks |
|
|
| 24 weeks |
|
|
| 0.99 |
Tukey's multiple comparisons test: |
| Superiority |
| Evaluate within group across time. | ANOVA | 0.84 | Tukey's multiple comparisons test: | Superiority |
| Evaluate within group across time. | ANOVA | 1.00 | Tukey's multiple comparisons test: | Superiority |
| Comparison across groups at baseline. | ANOVA | 0.96 | Superiority |
| Comparison across groups at 12-wks. | ANOVA | 0.86 | Superiority |
| Comparison across groups at 24-wks. | ANOVA | 0.92 | Superiority |
|
| Baseline-Post Exercise |
|
|
| 12-weeks-Pre Exercise |
|
|
| 12-weeks-Post Exercise |
|
|
| 24-weeks-Pre Exercise |
|
|
| 24-weeks-Post Exercise |
|
|
| t-test, 2 sided |
| 0.29 |
Unpaired two-tailed t-test: |
| Superiority |
| Evaluate within group pre- and post-test responses across time. | t-test, 2 sided | 0.36 | Unpaired two-tailed t-test: | Superiority |
| Evaluate within group pre- and post-test responses across time. | t-test, 2 sided | 0.15 | Unpaired two-tailed t-test: | Superiority |
| Comparison of pre- and post-responses across groups at baseline. | ANOVA | 0.20 | ANOVA | Superiority |
| Comparison of pre- and post-test responses across groups at 12 wks. | ANOVA | 0.51 | ANOVA | Superiority |
| Comparison of pre- and post-test responses across groups at 24 wks. | ANOVA | 0.59 | ANOVA | Superiority |
|
| 12-weeks |
|
|
| 24-weeks |
|
|
| 0.01 |
Dunn's multiple comparisons |
| Superiority |
| Evaluate within group across time | Kruskal-Wallis | 1.00 | Dunn's multiple comparisons | Superiority |
| Evaluate within group across time | Kruskal-Wallis | 0.98 | Dunn's multiple comparisons | Superiority |
| Comparison across groups at baseline | Kruskal-Wallis | 0.96 | Superiority |
| Comparison across groups at 12-wks | Kruskal-Wallis | 0.06 | Superiority |
| Comparison across groups at 24-wks | Kruskal-Wallis | 0.14 | Superiority |
|
| 12-weeks |
|
|
| 24-weeks |
|
|
| 0.36 |
Tukey's multiple comparisons test: |
| Superiority |
| Evaluate within group across time. | ANOVA | 0.93 | Tukey's multiple comparisons test: | Superiority |
| Evaluate within group across time. | ANOVA | 0.46 | Tukey's multiple comparisons test: | Superiority |
| Comparison across groups at baseline. | ANOVA | 0.14 | Superiority |
| Comparison across groups at 12 wks. | ANOVA | 0.05 | Superiority |
| Comparison across groups at 24 wks. | ANOVA | 0.01 | Superiority |
|
| 12-weeks |
|
|
| 24-weeks |
|
|
| 0.98 |
Tukey's multiple comparisons test: |
| Superiority |
| Evaluate within group across time. | ANOVA | 0.67 | Tukey's multiple comparisons test: | Superiority |
| Evaluate within group across time. | ANOVA | 0.55 | Tukey's multiple comparisons test: | Superiority |
| Comparison across groups at baseline. | ANOVA | 0.40 | Tukey's multiple comparisons test: | Superiority |
| Comparison across groups at 12 wks. | ANOVA | 0.47 | Superiority |
| Comparison across groups at 24 wks. | ANOVA | 0.43 | Superiority |
|
| 12-weeks |
|
|
| 24-weeks |
|
|
| 0.93 |
Tukey's multiple comparisons test: |
| Superiority |
| Evaluate within group across time. | ANOVA | 0.94 | Tukey's multiple comparisons test: | Superiority |
| Evaluate within group across time. | ANOVA | 0.94 | Tukey's multiple comparisons test: | Superiority |
| Comparison across groups at baseline. | ANOVA | 0.88 | Superiority |
| Comparison across groups at 12 wks. | ANOVA | 0.48 | Superiority |
| Comparison across groups at 24 wks. | ANOVA | 0.38 | Superiority |
|
| 12-weeks |
|
|
| 24-weeks |
|
|
| 0.93 |
Tukey's multiple comparisons test: |
| Superiority |
| Evaluate within group across time. | ANOVA | 0.51 | Tukey's multiple comparisons test: | Superiority |
| Evaluate within group across time. | ANOVA | 0.89 | Tukey's multiple comparisons test: | Superiority |
| Comparison across groups at baseline. | ANOVA | 0.46 | Superiority |
| Comparison across groups at 12 wks. | ANOVA | 0.72 | Superiority |
| Comparison across groups at 24wks. | ANOVA | 0.22 | Superiority |
|
| 12-weeks |
|
|
| 24-weeks |
|
|
| 0.99 |
Tukey's multiple comparisons test: |
| Superiority |
| Evaluate within group across time. | ANOVA | 0.87 | Tukey's multiple comparisons test: | Superiority |
| Evaluate within group across time. | ANOVA | 0.95 | Tukey's multiple comparisons test: | Superiority |
| Comparison across groups at baseline. | ANOVA | 0.39 | Superiority |
| Comparison across groups at 12-wks. | ANOVA | 0.59 | Superiority |
| Comparison across groups at 24-wks. | ANOVA | 0.29 | Superiority |
|
| 12-weeks |
|
|
| 24-weeks |
|
|
| 1.00 |
Tukey's multiple comparisons test: |
| Superiority |
| Evaluate within group across time. | ANOVA | 0.09 | Tukey's multiple comparisons test: | Superiority |
| Evaluate within group across time. | ANOVA | 0.05 | Tukey's multiple comparisons test: | Superiority |
| Comparison across groups at baseline. | ANOVA | 0.11 | Superiority |
| Comparison across groups at 12-wks. | ANOVA | 0.41 | Superiority |
| Comparison across groups at 24-wks. | ANOVA | 0.03 | Superiority |
|
| 12-weeks |
|
|
| 24-weeks |
|
|
| 1.00 |
Tukey's multiple comparisons test: |
| Superiority |
| Evaluate within group across time. | ANOVA | 0.87 | Tukey's multiple comparisons test: | Superiority |
| Evaluate within group across time. | ANOVA | 0.48 | Tukey's multiple comparisons test: | Superiority |
| Comparison across groups at baseline. | ANOVA | 0.58 | Superiority |
| Comparison across groups at 12-wks. | ANOVA | 0.50 | Superiority |
| Comparison across groups at 24-wks. | ANOVA | 0.33 | Superiority |
|
| 12-weeks |
|
|
| 24-weeks |
|
|
| 1.00 |
Tukey's multiple comparisons test: |
| Superiority |
| Evaluate within group across time. | ANOVA | 0.88 | Tukey's multiple comparisons test: | Superiority |
| Evaluate within group across time. | ANOVA | 0.93 | Tukey's multiple comparisons test: | Superiority |
| Comparison across groups at baseline. | ANOVA | 0.38 | Superiority |
| Comparison across groups at 12-wks. | ANOVA | 0.55 | Superiority |
| Comparison across groups at 24-wks | ANOVA | 0.37 | Superiority |
|
| 12-wks |
|
|
| 24-wks |
|
|
| 1.00 |
Dunn's multiple comparisons test: |
| Superiority |
| Evaluate within group across time | Kruskal-Wallis | 1.00 | Dunn's multiple comparisons test: | Superiority |
| Evaluate within group across time. | Kruskal-Wallis | 1.00 | Dunn's multiple comparisons test: | Superiority |
| Comparison across groups at baseline | Kruskal-Wallis | 0.81 | Superiority |
| Comparison across groups at 12-wks | Kruskal-Wallis | 0.60 | Superiority |
| Comparison across groups at 24-wks | Kruskal-Wallis | 0.99 | Superiority |
|
| 12-wks |
|
|
| 24-wks |
|
|
| 1.00 |
Tukey's multiple comparisons test: |
| Superiority |
| Evaluate within group across time. | ANOVA | 1.00 | Tukey's multiple comparisons test: | Superiority |
| Evaluate within group across time. | ANOVA | 0.72 | Tukey's multiple comparisons test: | Superiority |
| Comparison across groups at baseline. | ANOVA | 0.62 | Superiority |
| Comparison across groups at 12 wks. | ANOVA | 0.33 | Superiority |
| Comparison across groups at 24 wks. | ANOVA | 0.38 | Superiority |
|
| 12-wk |
|
|
| 24-wk |
|
|
| 1.00 |
Tukey's multiple comparisons test: |
| Superiority |
| Evaluate within group across time. | ANOVA | 1.00 | Tukey's multiple comparisons test: | Superiority |
| Evaluate within group across time. | ANOVA | 0.76 | Tukey's multiple comparisons test: | Superiority |
| Comparison across groups at baseline. | ANOVA | 0.82 | Superiority |
| Comparison across groups at 12 wks. | ANOVA | 0.53 | Superiority |
| Comparison across groups at 24 wks. | ANOVA | 0.68 | Superiority |
|
| 12-wk |
|
|
| 24-wk |
|
|
| HDL-Cholesterol |
|
| LDL-Cholesterol |
|