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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL117037 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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Each year, 11,000 people suffer a spinal cord injury (SCI) in the U.S. Within the first year, there are profound declines in physiologic function, forming the underlying substrate for future cardiovascular disease . In fact, acquired cardiovascular disease is an increasingly recognized consequence of SCI and is the leading cause of death in SCI. Though incompletely understood, the almost 10-fold prevalence of cardiovascular disease results in part from profound physiologic 'detraining' resulting from motor impairment and immobility. Currently, effective interventions preventing acute declines that lead to cardiovascular compromise and increased risk in SCI are lacking - exercise therapy for those with SCI is challenging and when employed, is typically limited to the upper body. Recently, the investigators refined a unique form of exercise for those with SCI that specifically mirrors exercise performed by those without SCI. Functional Electrical Stimulation (FES) Row Training (RT) couples volitional arm and electrically controlled leg exercise, resulting in a hemodynamic profile that produces the beneficial cardiac loading conditions of large muscle mass exercise. As such, FES-RT may be a safe and effective way to attenuate cardiovascular declines following SCI. The investigators aims are to test the overall hypotheses that FES-RT will: 1) mitigate against increased visceral adiposity and reduced insulin sensitivity, 2) prevent worsening lipid profile and compromised baroreflex function, and 3) counter ventricular wall thickening and declining ventricular function occurring with acute SCI, and that these effects will be greater than that observed with an arms-only exercise group. Changes with FES-RT will be compared to a time (wait-list) control and to arms-only-RT. Individuals with an SCI within the last 3-6 months will be randomized to FES-RT, to a time control, or arms-only-RT. Measures will be made at baseline and 6 months. The investigators work will provide results that clearly delineate potential health benefits of FES-RT, and if FES-RT is effective in a majority of those with SCI, its application, implementation, and integration could be easily replicated.
We will enroll approximately 60 individuals within three to six months post SCI to obtain data on 50 individuals. One-half of the subjects (N=25) will be randomized to immediately enroll in 6 months of FES-RT. One third (N=18) will be randomized to a wait-list to provide time control data from baseline to 6 months. A wait-list control group is routine in exercise studies because most volunteers are interested in participating in an exercise program. Hence, time controls are difficult to capture since many of those randomized to receive no exercise either drop from the study entirely, or end up pursuing some form of exercise on their own. Therefore, a vehicle for enrollment of a time control group that is acceptable to most volunteers is a wait-list. Therefore, a six month time control will provide data on expected declines and then subjects will be randomized to six months exercise.
Training Protocols for Each Study Group
FES-RT GROUP
Subjects will begin with short intervals of FES-RT interspersed with rest intervals and/or arms-only rowing intervals depending on fitness level and the response to the FES. A maximum FES-rowing test will be performed at baseline. This will be repeated after three months of training and training intensity will be adjusted to maintain the training stimulus at the same relative intensity. The goal is for each volunteer to achieve an exercise intensity of 75-85% maintained for a continuous 30 minutes performed three times each week. A maximum FES-rowing test will be performed at the end of the six months of FES-RT to determine increases in fitness.
ARMS-ONLY-RT GROUP
Training sessions will be 3 times per week for 26 weeks. To parallel the FES-RT, the initial training sessions will also consist of 6 sets of arms-only rowing for five minutes at 60% of VO2peak with a work-to-rest ratio of 2:1 and progress over the six months to an exercise intensity of 75-85% maintained for 30 minutes performed three times each week. A maximum arms-only rowing test will be performed at baseline. This will be repeated after three months of training and training intensity will be adjusted to maintain the training stimulus at the same relative intensity. A maximum arms-only rowing test will be performed at the end of the six months of training to determine increases in fitness.
WAIT-LIST GROUP
The wait list group will not participate in any training for 6 months. A maximum arms-only rowing test will be performed immediately after enrollment, after initial familiarization with arms-only-RT equipment (usually 2-3 sessions) and will be repeated after 3 and 6 months
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FES-row-training | Experimental | Subjects will perform 6 months of FES-row-training. |
|
| Wait-list time control | Other | Subjects perform 6 months of their standard of care |
|
| Arms-only-row-training | Active Comparator | Subjects will perform 6 months of arms-only row training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FES-row-training | Other |
| ||
| Arms-only-row training |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Exercise Capacity at 6 Months | Volunteers will perform an incremental exercise test of FES- or arms-only rowing to determine maximal oxygen uptake. | Baseline and 6 months |
| Change From Baseline in Visceral Adiposity at 6 Months | We will use a 5th generation General Electric Healthcare dual x-ray absorptiometry(DXA) scanner for regional fat measurements, the DXA software can be used to define standard regions that will allow comparability of measurements throughout the study. | Baseline, 6 months |
| Change From Baseline in Myocardial Structure at 6 Months. | Echocardiography was performed using a commercially available system(Vivid-1, General Electric Healthcare)to obtain measures of left ventricular wall thickness and left ventricular diastolic function. | Baseline and 6 months |
| Change From Baseline in Insulin Sensitivity at 6 Months. | Blood will be taken via standard venipuncture to measure the homeostasis model assessment of insulin resistance (HOMA-IR). HOMA-IR is a measure of insulin resistance/sensitivity calculated by multiplying fasting insulin (μU/mL) by fasting glucose (mg/dL) and divided by a constant (405). A higher value indicates higher insulin resistance. | Baseline and 6 months |
| Change From Baseline in Blood Lipids at 6 Months | Blood will be taken via standard venipuncture to measure: total cholesterol. | Baseline and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J. Andrew Taylor, Ph.D. | Spaulding Rehabilitation Hospital/Harvard Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Hospital Cambridge | Cambridge | Massachusetts | 02138 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36622954 | Derived | Yates BA, Brown R, Picard G, Taylor JA. Improved pulmonary function is associated with reduced inflammation after hybrid whole-body exercise training in persons with spinal cord injury. Exp Physiol. 2023 Mar;108(3):353-360. doi: 10.1113/EP090785. Epub 2023 Jan 9. | |
| 36572202 | Derived | Ely MR, Schleifer GD, Singh TK, Baggish AL, Taylor JA. Exercise Training Does Not Attenuate Cardiac Atrophy or Loss of Function in Individuals With Acute Spinal Cord Injury: A Pilot Study. Arch Phys Med Rehabil. 2023 Jun;104(6):909-917. doi: 10.1016/j.apmr.2022.12.001. Epub 2022 Dec 23. |
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| ID | Title | Description |
|---|---|---|
| FG000 | FES-row-training | Subjects will perform 6 months of FES-row-training. FES-row-training |
| FG001 | Wait-list Time Control | Subjects perform 6 months of their standard of care Time Control |
| FG002 | Arms-only-row-training | Subjects will perform 6 months of arms-only row training Arms-only-row training |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This analysis is a subset of the total number of participants in the whole study from which complete data was available
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| ID | Title | Description |
|---|---|---|
| BG000 | FES-row-training | Subjects will perform 6 months of FES-row-training. FES-row-training |
| BG001 | Wait-list Time Control | Subjects perform 6 months of their standard of care Time Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change From Baseline in Exercise Capacity at 6 Months | Volunteers will perform an incremental exercise test of FES- or arms-only rowing to determine maximal oxygen uptake. | The reported results represent a sub-population of the total number of subjects who completed the study. Some subjects did not complete the 6 month VO2 or their results were removed due to quality control or not meeting the criteria for a good test. Therefore, the presented numbers represent reliable and unbiased data. | Posted | Mean | Standard Error | ml/kg/min | Baseline and 6 months |
|
up to 6 months
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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 | FES-row-training | Subjects will perform 6 months of FES-row-training. FES-row-training |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Autonomic Dysreflexia | Cardiac disorders | Non-systematic Assessment | Autonomic dysreflexia (AD) characterized by a sudden abnormal elevation in blood pressure. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Low Blood Pressure | Cardiac disorders | Non-systematic Assessment | Low BP is common in individuals with SCI. Excluded from exercise if BP is low. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Glen Picard | Spaulding Rehabilitation Hospital | 6177585511 | gpicard@partners.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 25, 2020 | Feb 24, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| C106535 | Flowering time control protein FCA, Arabidopsis |
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Three intervention groups (Control, AO-Row, and FES-RT) run in parallel
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|
| Time Control | Other |
|
| 35077032 | Derived | Solinsky R, Schleifer GD, Draghici AE, Hamner JW, Taylor JA. Methodologic implications for rehabilitation research: Differences in heart rate variability introduced by respiration. PM R. 2022 Dec;14(12):1483-1489. doi: 10.1002/pmrj.12770. Epub 2022 Mar 12. |
| 33661958 | Derived | Solinsky R, Draghici A, Hamner JW, Goldstein R, Taylor JA. High-intensity, whole-body exercise improves blood pressure control in individuals with spinal cord injury: A prospective randomized controlled trial. PLoS One. 2021 Mar 4;16(3):e0247576. doi: 10.1371/journal.pone.0247576. eCollection 2021. |
| 33556347 | Derived | Ely MR, Singh TK, Baggish AL, Taylor JA. Reductions in Cardiac Structure and Function 24 Months After Spinal Cord Injury: A Cross-Sectional Study. Arch Phys Med Rehabil. 2021 Aug;102(8):1490-1498. doi: 10.1016/j.apmr.2021.01.070. Epub 2021 Feb 5. |
| BG002 | Arms-only-row-training | Subjects will perform 6 months of arms-only row training Arms-only-row training |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Arms Only Rowing
| OG002 | FES-Rowing | Functional Electrical Stimulation Rowing |
|
|
| Primary | Change From Baseline in Visceral Adiposity at 6 Months | We will use a 5th generation General Electric Healthcare dual x-ray absorptiometry(DXA) scanner for regional fat measurements, the DXA software can be used to define standard regions that will allow comparability of measurements throughout the study. | These are subgroups of the main study population. Exercise groups were combined. | Posted | Mean | Standard Error | g | Baseline, 6 months |
|
|
|
| Primary | Change From Baseline in Myocardial Structure at 6 Months. | Echocardiography was performed using a commercially available system(Vivid-1, General Electric Healthcare)to obtain measures of left ventricular wall thickness and left ventricular diastolic function. | The reported results represent a sub-population of the total number of subjects who completed the study. Some subjects did not complete the 6 month echocardiography or their results were removed due to quality control or not meeting the criteria for a good test. Therefore, the presented numbers represent reliable and unbiased data. | Posted | Mean | Standard Error | g | Baseline and 6 months |
|
|
|
| Primary | Change From Baseline in Insulin Sensitivity at 6 Months. | Blood will be taken via standard venipuncture to measure the homeostasis model assessment of insulin resistance (HOMA-IR). HOMA-IR is a measure of insulin resistance/sensitivity calculated by multiplying fasting insulin (μU/mL) by fasting glucose (mg/dL) and divided by a constant (405). A higher value indicates higher insulin resistance. | The reported results represent a sub-population of the total number of subjects who completed the study. Some subjects did not complete the 6 month blood draw. Therefore, the presented numbers represent reliable and unbiased data. | Posted | Mean | Standard Error | HOMA-IR Index | Baseline and 6 months |
|
|
|
| Primary | Change From Baseline in Blood Lipids at 6 Months | Blood will be taken via standard venipuncture to measure: total cholesterol. | The reported results represent a sub-population of the total number of subjects who completed the study. Some subjects did not complete the 6 month blood draw. Therefore, the presented numbers represent reliable and unbiased data. | Posted | Mean | Standard Error | mg/dL | Baseline and 6 months |
|
|
|
| 0 |
| 41 |
| 0 |
| 41 |
| 8 |
| 41 |
| EG001 | Wait-list Time Control | Subjects perform 6 months of their standard of care Time Control | 0 | 14 | 1 | 14 | 0 | 14 |
| EG002 | Arms-only-row-training | Subjects will perform 6 months of arms-only row training Arms-only-row training | 0 | 13 | 1 | 13 | 1 | 13 |
|
|
| Skin Ulcer | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Pressure ulcers are common in individuals with SCI |
|
| Elevated Blood Pressure | Cardiac disorders | Non-systematic Assessment | Temporary elevations in blood pressure, not related to autonomic dysreflexia, which subsides with 10 minutes of rest |
|
| Arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Inflammation of a joint. |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment | Reports of sickness following exercise/testing |
|
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| D014947 | Wounds and Injuries |
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|
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