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| ID | Type | Description | Link |
|---|---|---|---|
| UL1RR031990 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Research Resources (NCRR) | NIH |
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The purpose of this proposal was to evaluate and compare the health benefits of using upper extremity exercise versus functional electrical stimulation for lower extremity exercise. It was our hypothesis that both Functional Electrical Stimulation Leg Cycle Ergometry (FES LCE) exercise and voluntary Arm Crank Ergometry (ACE) upper extremity exercise would increase whole body energy expenditure, thereby increasing muscle mass, insulin sensitivity, glucose effectiveness and improving lipid profiles in adults with paraplegia.
Objective: Spinal cord injuries (SCI) predispose individuals to impaired fitness, obesity, glucose intolerance and insulin resistance, placing them at greater risk for diabetes, coronary artery disease, and upper extremity overuse syndrome as body weight increases. The specific objectives for the current proposal were to compare the impact of FES (functional electrical stimulation) lower extremity exercise versus upper extremity arm crank ergometry on energy metabolism, body composition and fat deposition, insulin sensitivity, glucose effectiveness, lower extremity bone mineral density and lipid profiles, in adults with complete paraplegia. Research Plan: A randomized, baseline-controlled, prospective, 16-week interventional trial was employed to assess the impact of FES LCE versus volitional arm crank ergometry exercise on energy metabolism, body composition and fat deposition, insulin sensitivity, glucose effectiveness, lower extremity bone mineral density and lipid profiles in adults with complete paraplegia. Methods: Twenty-four 18-65 y.o. individuals with motor complete T4-L2 SCI were assigned to either FES lower extremity exercise or upper extremity arm crank ergometry to compare impact on energy expenditure, obesity, and insulin sensitivity. Both groups were provided similar nutritional assessments and intervention. Exercise training consisted of five, 40-minute sessions at 70% maximal heart rate (HRmax) each week for a total of 16 weeks. Resting metabolic rate, exercise energy expenditure, body composition by DXA, insulin sensitivity, glucose effectiveness, lipid profiles, and lower extremity bone mineral density (BMD) were determined before and after 16-week exercise interventions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm Crank Ergometer | Other | Upper body Cycle ergometer Exercise: 10-minute warm up, 40 minutes @ 70%HRMax (50RPM), 10 minute cool down 5x/week x 16 weeks |
|
| FESLCE | Other | Functional Electrical Stimulation Leg Cycle Ergometer Exercise: 10-minute warm up, 40 minutes @ 70%HRMax (50RPM), 10 minute cool down 5x/week x 16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arm Crank Ergometry | Procedure | Use of an upper body cycle to perform exercise. 10-minute warm up, 40 minutes @ 70%HRMax (50RPM), 10 minute cool down 5x/week x 16 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in % Body Fat | Change in % Body Fat after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value. | baseline, 16 weeks |
| Change in Fat Mass | Change in Fat Mass (Kg) after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value. | Baseline, 16 Weeks |
| Change in Fat-Free Mass | Fat-Free Mass (kg). Change score was calculated as final value (i.e., post intervention variable) minus baseline value. | baseline, 16 weeks |
| Change in Glucose Effectiveness (Sg) | Change in Glucose Effectiveness (min^-1). Change score was calculated as final value (i.e., post intervention variable) minus baseline value. | Baseline, 16-weeks |
| Change in Insulin Sensitivity (Si) | Change in insulin sensitivity (min^-1). Change score was calculated as final value (i.e., post intervention variable) minus baseline value. | Baseline, 16-weeks |
| %Body Fat Between Groups | Comparison of %body fat between the ACE and FESLCE groups following the 16 week intervention. | 16 weeks |
| Fat Mass Between Groups | Comparison of fat mass between the ACE and FESLCE groups following the 16 week intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Lower Limb Bone Mineral Density | Change in lower limb bone mineral density after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value. | baseline, 16 weeks |
| Change in Lower Limb Bone Mineral Content |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Resting Metabolic Rate | Change in resting metabolic rate after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value. | baseline, 16 weeks |
| Resting Metabolic Rate Between Groups |
Inclusion Criteria:
Criteria for participation included men and women within the age range of 18-65 years old with BMI>25 kg/m2 who have had T4-L2 Motor-Complete (ASIA A&B) SCI for duration of greater than 12 months to ensure a homogenous sample.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David R Gater, MD PhD MS | Hunter Holmes McGuire VA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunter Holmes McGuire VA Medical Center | Richmond | Virginia | 23249 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm Crank Ergometer | Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise. |
| FG001 | FESLCE | Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm Cycling Ergometer | Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise. |
| BG001 | FESLCE | Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise |
| 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 | Change in % Body Fat | Change in % Body Fat after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value. | Two exercise groups consisted of an arm crank ergometry group and an FESLCE group. | Posted | Mean | Standard Deviation | Percent Body Fat | baseline, 16 weeks |
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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 | Arm Cycling Ergometer | Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise. |
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The number of subjects that withdrew lead to small numbers of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Gater | Penn State Hershey Medical Center | 7175314263 | dgater@hmc.psu.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D009765 | Obesity |
| D010264 | Paraplegia |
| D011782 | Quadriplegia |
| D013119 | Spinal Cord Injuries |
| D009043 | Motor Activity |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| FES Cycle Ergometer | Procedure | Use of an FES cycle ergometer to perform exercise. 10-minute warm up, 40 minutes @ 70%HRMax (50RPM), 10 minute cool down 5x/week x 16 weeks |
|
| 16 weeks |
| Fat Free Mass Between Groups | Comparison of fat free mass between the ACE and FESLCE groups following the 16 week intervention. | 16 weeks |
| Insulin Sensitivity (Si) Between Groups | Comparison of Si between the ACE and FESLCE groups following the 16 week intervention. | 16 weeks |
| Glucose Effectiveness (Sg) Between Groups | Comparison of Sg between the ACE and FESLCE groups following the 16 week intervention. | 16 weeks |
Change in lower limb bone mineral content after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value. |
| baseline, 16 weeks |
| Change in Triglycerides | Change in triglycerides after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value. | baseline, 16 weeks |
| Change in High Density Lipoprotein Cholesterol (HDL) | Change in HDL after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value. | baseline, 16 weeks |
| Change in Low Density Lipoprotein Cholesterol (LDL) | Change in LDL after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value. | baseline, 16 weeks |
| Change in Total Cholesterol (TC) | Change in TC after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value. | baseline, 16 weeks |
| Change in the Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL) | Change in TC:HDL after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value. | Baseline, 16 weeks |
| Lower Limb Bone Mineral Density Between Groups | Comparison of Lower limb bone mineral density between the ACE and FESLCE groups following the 16 week intervention | 16 weeks |
| Lower Limb Bone Mineral Content Between Groups | Comparison of Lower limb bone mineral content between the ACE and FESLCE groups following the 16 week intervention | 16 weeks |
| Triglycerides Between Groups | Comparison of Triglycerides between the ACE and FESLCE groups following the 16 week intervention | 16 weeks |
| High Density Lipoprotein Cholesterol (HDL) Between Groups | Comparison of HDL between the ACE and FESLCE groups following the 16 week intervention | 16 weeks |
| Low Density Lipoprotein Cholesterol (LDL) Between Groups | Comparison of LDL between the ACE and FESLCE groups following the 16 week intervention | 16 weeks |
| Total Cholesterol (TC) Between Groups | Comparison of TC between the ACE and FESLCE groups following the 16 week intervention | 16 weeks |
| Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL) Between Groups | Comparison of Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL) between the ACE and FESLCE groups following the 16 week intervention | 16 weeks |
Comparison of resting metabolic rate between the ACE and FESLCE groups following the 16 week intervention
| 16 weeks |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| % Body Fat | Mean | Standard Deviation | Percent Body Fat |
|
| Fat Mass (Kg) | Mean | Standard Deviation | Kg |
|
| Fat-Free Mass (kg) | Mean | Standard Deviation | Kg |
|
| Glucose Effectiveness (Sg) | Mean | Standard Deviation | min^-1 |
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| Insulin Sensitivity (Si) | Mean | Standard Deviation | μu/ml |
|
| Exercise Energy Expenditure (Kcal/session) | Mean | Standard Deviation | Kcal/session |
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| Resting Metabolic Rate | Mean | Standard Deviation | Kcal/d |
|
| Total Cholesterol | Mean | Standard Deviation | mg/dl |
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| HDL-Cholesterol | Mean | Standard Deviation | mg/dl |
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| Bone Mineral Density | Mean | Standard Deviation | g/cm^2 |
|
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| Primary | Change in Fat Mass | Change in Fat Mass (Kg) after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value. | Two exercise groups consisted of an arm crank ergometry group and an FESLCE group. | Posted | Mean | Standard Deviation | Kg | Baseline, 16 Weeks |
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| Primary | Change in Fat-Free Mass | Fat-Free Mass (kg). Change score was calculated as final value (i.e., post intervention variable) minus baseline value. | Two exercise groups consisted of an arm crank ergometry group and an FESLCE group. | Posted | Mean | Standard Deviation | Kg | baseline, 16 weeks |
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|
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| Primary | Change in Glucose Effectiveness (Sg) | Change in Glucose Effectiveness (min^-1). Change score was calculated as final value (i.e., post intervention variable) minus baseline value. | Two exercise groups consisted of an arm crank ergometry group and an FESLCE group. | Posted | Mean | Standard Deviation | min^-1 | Baseline, 16-weeks |
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| Primary | Change in Insulin Sensitivity (Si) | Change in insulin sensitivity (min^-1). Change score was calculated as final value (i.e., post intervention variable) minus baseline value. | Two exercise groups consisted of an arm crank ergometry group and an FESLCE group. | Posted | Mean | Standard Deviation | min^-1 | Baseline, 16-weeks |
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| Primary | %Body Fat Between Groups | Comparison of %body fat between the ACE and FESLCE groups following the 16 week intervention. | Two exercise groups consisted of an arm crank ergometry group and an FESLCE group. | Posted | Mean | Standard Deviation | Percent Body Fat | 16 weeks |
|
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| Primary | Fat Mass Between Groups | Comparison of fat mass between the ACE and FESLCE groups following the 16 week intervention. | Two exercise groups consisted of an arm crank ergometry group and an FESLCE group. | Posted | Mean | Standard Deviation | kg | 16 weeks |
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| Primary | Fat Free Mass Between Groups | Comparison of fat free mass between the ACE and FESLCE groups following the 16 week intervention. | Two exercise groups consisted of an arm crank ergometry group and an FESLCE group. | Posted | Mean | Standard Deviation | kg | 16 weeks |
|
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| Primary | Insulin Sensitivity (Si) Between Groups | Comparison of Si between the ACE and FESLCE groups following the 16 week intervention. | Two exercise groups consisted of an arm crank ergometry group and an FESLCE group. | Posted | Mean | Standard Deviation | min^-1 | 16 weeks |
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| Primary | Glucose Effectiveness (Sg) Between Groups | Comparison of Sg between the ACE and FESLCE groups following the 16 week intervention. | Two exercise groups consisted of an arm crank ergometry group and an FESLCE group. | Posted | Mean | Standard Deviation | min^-1 | 16 weeks |
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| Secondary | Change in Lower Limb Bone Mineral Density | Change in lower limb bone mineral density after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value. | Two exercise groups consisted of an arm crank ergometry group and an FESLCE group. | Posted | Mean | Standard Deviation | g*(cm^2)^-1 | baseline, 16 weeks |
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| Secondary | Change in Lower Limb Bone Mineral Content | Change in lower limb bone mineral content after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value. | Two exercise groups consisted of an arm crank ergometry group and an FESLCE group. | Posted | Mean | Standard Deviation | grams | baseline, 16 weeks |
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| Secondary | Change in Triglycerides | Change in triglycerides after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value. | Two exercise groups consisted of an arm crank ergometry group and an FESLCE group. | Posted | Mean | Standard Deviation | mg/dL | baseline, 16 weeks |
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| Secondary | Change in High Density Lipoprotein Cholesterol (HDL) | Change in HDL after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value. | Two exercise groups consisted of an arm crank ergometry group and an FESLCE group. | Posted | Mean | Standard Deviation | mg/dL | baseline, 16 weeks |
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| Secondary | Change in Low Density Lipoprotein Cholesterol (LDL) | Change in LDL after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value. | Two exercise groups consisted of an arm crank ergometry group and an FESLCE group. | Posted | Mean | Standard Deviation | mg/dL | baseline, 16 weeks |
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| Secondary | Change in Total Cholesterol (TC) | Change in TC after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value. | Two exercise groups consisted of an arm crank ergometry group and an FESLCE group. | Posted | Mean | Standard Deviation | mg/dL | baseline, 16 weeks |
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| Secondary | Change in the Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL) | Change in TC:HDL after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value. | Two exercise groups consisted of an arm crank ergometry group and an FESLCE group. | Posted | Mean | Standard Deviation | Ratio | Baseline, 16 weeks |
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| Secondary | Lower Limb Bone Mineral Density Between Groups | Comparison of Lower limb bone mineral density between the ACE and FESLCE groups following the 16 week intervention | Two exercise groups consisted of an arm crank ergometry group and an FESLCE group. | Posted | Mean | Standard Deviation | g*(cm^2)^-1 | 16 weeks |
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| Secondary | Lower Limb Bone Mineral Content Between Groups | Comparison of Lower limb bone mineral content between the ACE and FESLCE groups following the 16 week intervention | Two exercise groups consisted of an arm crank ergometry group and an FESLCE group. | Posted | Mean | Standard Deviation | grams | 16 weeks |
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| Secondary | Triglycerides Between Groups | Comparison of Triglycerides between the ACE and FESLCE groups following the 16 week intervention | Two exercise groups consisted of an arm crank ergometry group and an FESLCE group. | Posted | Mean | Standard Deviation | mg/dL | 16 weeks |
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| Secondary | High Density Lipoprotein Cholesterol (HDL) Between Groups | Comparison of HDL between the ACE and FESLCE groups following the 16 week intervention | Two exercise groups consisted of an arm crank ergometry group and an FESLCE group. | Posted | Mean | Standard Deviation | mg/dL | 16 weeks |
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| Secondary | Low Density Lipoprotein Cholesterol (LDL) Between Groups | Comparison of LDL between the ACE and FESLCE groups following the 16 week intervention | Two exercise groups consisted of an arm crank ergometry group and an FESLCE group. | Posted | Mean | Standard Deviation | mg/dL | 16 weeks |
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| Secondary | Total Cholesterol (TC) Between Groups | Comparison of TC between the ACE and FESLCE groups following the 16 week intervention | Two exercise groups consisted of an arm crank ergometry group and an FESLCE group. | Posted | Mean | Standard Deviation | mg/dL | 16 weeks |
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| Secondary | Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL) Between Groups | Comparison of Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL) between the ACE and FESLCE groups following the 16 week intervention | Two exercise groups consisted of an arm crank ergometry group and an FESLCE group. | Posted | Mean | Standard Deviation | Ratio | 16 weeks |
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| Other Pre-specified | Change in Resting Metabolic Rate | Change in resting metabolic rate after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value. | Two exercise groups consisted of an arm crank ergometry group and an FESLCE group. | Posted | Mean | Standard Deviation | kcal/day | baseline, 16 weeks |
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| Other Pre-specified | Resting Metabolic Rate Between Groups | Comparison of resting metabolic rate between the ACE and FESLCE groups following the 16 week intervention | Two exercise groups consisted of an arm crank ergometry group and an FESLCE group. | Posted | Mean | Standard Deviation | kcal/day | 16 weeks |
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|
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | FESLCE | Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise | 0 | 6 | 0 | 6 |
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| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D001519 | Behavior |
| D006946 | Hyperinsulinism |
| t-test, 2 sided |
| >0.05 |
| Non-Inferiority or Equivalence |
A Wilcoxon signed-rank test was performed. |
| t-test, 2 sided |
| >0.05 |
| Non-Inferiority or Equivalence |
A Wilcoxon signed-rank test was performed. |
| t-test, 2 sided |
| >0.05 |
| Non-Inferiority or Equivalence |
A Wilcoxon signed-rank test was performed. |
| t-test, 2 sided |
| >0.05 |
| Non-Inferiority or Equivalence |
A Wilcoxon signed-rank test was performed. |
| t-test, 2 sided |
| >0.05 |
| Non-Inferiority or Equivalence |
A Wilcoxon signed-rank test was performed. |
| t-test, 2 sided |
| >0.05 |
| Non-Inferiority or Equivalence |
A Wilcoxon signed-rank test was performed. |
| t-test, 2 sided |
| >0.05 |
| Non-Inferiority or Equivalence |
A Wilcoxon signed-rank test was performed. |
| t-test, 2 sided |
| >0.05 |
| Non-Inferiority or Equivalence |
A Wilcoxon signed-rank test was performed. |
| t-test, 2 sided |
| >0.05 |
| Non-Inferiority or Equivalence |
A Wilcoxon signed-rank test was performed. |
| t-test, 2 sided |
| >0.05 |
| Non-Inferiority or Equivalence |
A Wilcoxon signed-rank test was performed. |
| t-test, 2 sided |
| >0.05 |
| Non-Inferiority or Equivalence |
A Wilcoxon signed-rank test was performed. |
| t-test, 2 sided |
| >0.05 |
| Non-Inferiority or Equivalence |
A Wilcoxon signed-rank test was performed. |