Diabetes Mellitus, Obesity, Paraplegia, Quadriplegia, Spinal Cord Injury
Conditions
Keywords
Body Composition, Exercise, Glucose Tolerance, Insulin Sensitivity, Functional Electric Stimulation
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREArm Crank Ergometry
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
PROCEDUREFES Cycle Ergometer
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
Sponsors
National Center for Research Resources (NCRR)
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
* persons who were unresponsive to surface neurostimulation * had participated in an FES or ACE exercise (\> 60 minutes/week) program within the past 3 months * and those with known orthopedic limitations * CAD * diabetes mellitus (fasting glucose\>126 or HgbA1c\>7.0) or known family history * hypothyroidism * and/or renal disease were excluded from the study. * Additionally, individuals with uncontrolled autonomic dysreflexia, recent (within 3 months) deep vein thrombosis, or pressure ulcers \> Grade II were excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose Effectiveness (Sg) Between Groups | 16 weeks | Comparison of Sg between the ACE and FESLCE groups following the 16 week intervention. |
| Insulin Sensitivity (Si) Between Groups | 16 weeks | Comparison of Si between the ACE and FESLCE groups following the 16 week intervention. |
| Change in % Body Fat | baseline, 16 weeks | Change in % Body Fat after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value. |
| Change in Fat Mass | Baseline, 16 Weeks | Change in Fat Mass (Kg) after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value. |
| Change in Fat-Free Mass | baseline, 16 weeks | Fat-Free Mass (kg). Change score was calculated as final value (i.e., post intervention variable) minus baseline value. |
| Change in Glucose Effectiveness (Sg) | Baseline, 16-weeks | Change in Glucose Effectiveness (min\^-1). Change score was calculated as final value (i.e., post intervention variable) minus baseline value. |
| Change in Insulin Sensitivity (Si) | Baseline, 16-weeks | Change in insulin sensitivity (min\^-1). Change score was calculated as final value (i.e., post intervention variable) minus baseline value. |
| %Body Fat Between Groups | 16 weeks | Comparison of %body fat between the ACE and FESLCE groups following the 16 week intervention. |
| Fat Mass Between Groups | 16 weeks | Comparison of fat mass between the ACE and FESLCE groups following the 16 week intervention. |
| Fat Free Mass Between Groups | 16 weeks | Comparison of fat free mass between the ACE and FESLCE groups following the 16 week intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Triglycerides Between Groups | 16 weeks | Comparison of Triglycerides between the ACE and FESLCE groups following the 16 week intervention |
| High Density Lipoprotein Cholesterol (HDL) Between Groups | 16 weeks | Comparison of HDL between the ACE and FESLCE groups following the 16 week intervention |
| Total Cholesterol (TC) Between Groups | 16 weeks | Comparison of TC between the ACE and FESLCE groups following the 16 week intervention |
| Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL) Between Groups | 16 weeks | Comparison of Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL) between the ACE and FESLCE groups following the 16 week intervention |
| Low Density Lipoprotein Cholesterol (LDL) Between Groups | 16 weeks | Comparison of LDL between the ACE and FESLCE groups following the 16 week intervention |
| Change in Lower Limb Bone Mineral Density | baseline, 16 weeks | 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. |
| Change in Lower Limb Bone Mineral Content | baseline, 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. |
| Change in Triglycerides | baseline, 16 weeks | Change in triglycerides after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value. |
| Change in High Density Lipoprotein Cholesterol (HDL) | baseline, 16 weeks | Change in HDL after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value. |
| Change in Low Density Lipoprotein Cholesterol (LDL) | baseline, 16 weeks | Change in LDL after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value. |
| Change in Total Cholesterol (TC) | baseline, 16 weeks | Change in TC after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value. |
| Change in the Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL) | Baseline, 16 weeks | Change in TC:HDL after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value. |
| Lower Limb Bone Mineral Density Between Groups | 16 weeks | Comparison of Lower limb bone mineral density between the ACE and FESLCE groups following the 16 week intervention |
| Lower Limb Bone Mineral Content Between Groups | 16 weeks | Comparison of Lower limb bone mineral content between the ACE and FESLCE groups following the 16 week intervention |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Resting Metabolic Rate | baseline, 16 weeks | Change in resting metabolic rate after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value. |
| Resting Metabolic Rate Between Groups | 16 weeks | Comparison of resting metabolic rate between the ACE and FESLCE groups following the 16 week intervention |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm Cycling Ergometer Upper body Cycle ergometer
Arm Crank Ergometry: Use of an upper body cycle to perform exercise. | 7 |
| FESLCE Functional Electrical Stimulation Cycle Ergometer for Lower body
FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise | 6 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 8 | 8 |
Baseline characteristics
| Characteristic | FESLCE | Total | Arm Cycling Ergometer |
|---|---|---|---|
| Age, Continuous | 39 Years STANDARD_DEVIATION 14 | 40.5 Years STANDARD_DEVIATION 12 | 42 Years STANDARD_DEVIATION 10 |
| % Body Fat | 41.6 Percent Body Fat STANDARD_DEVIATION 7.1 | 40.75 Percent Body Fat STANDARD_DEVIATION 7.4 | 38.9 Percent Body Fat STANDARD_DEVIATION 6.9 |
| Bone Mineral Density | 1.293 g/cm^2 STANDARD_DEVIATION 0.135 | 1.209 g/cm^2 STANDARD_DEVIATION 0.14 | 1.138 g/cm^2 STANDARD_DEVIATION 0.104 |
| Exercise Energy Expenditure (Kcal/session) | 80.7 Kcal/session STANDARD_DEVIATION 32.6 | 101 Kcal/session STANDARD_DEVIATION 34 | 128.3 Kcal/session STANDARD_DEVIATION 35.4 |
| Fat-Free Mass (kg) | 49.5 Kg STANDARD_DEVIATION 11.2 | 49.55 Kg STANDARD_DEVIATION 10.15 | 49.6 Kg STANDARD_DEVIATION 9.1 |
| Fat Mass (Kg) | 33.4 Kg STANDARD_DEVIATION 11 | 31.5 Kg STANDARD_DEVIATION 8.7 | 29.6 Kg STANDARD_DEVIATION 6.4 |
| Glucose Effectiveness (Sg) | 0.017 min^-1 STANDARD_DEVIATION 0.01 | 0.02 min^-1 STANDARD_DEVIATION 0.01 | 0.023 min^-1 STANDARD_DEVIATION 0.01 |
| HDL-Cholesterol | 37.8 mg/dl STANDARD_DEVIATION 8.3 | 36.7 mg/dl STANDARD_DEVIATION 7.1 | 35.7 mg/dl STANDARD_DEVIATION 6.4 |
| Insulin Sensitivity (Si) | 2.7 μu/ml STANDARD_DEVIATION 2 | 2.85 μu/ml STANDARD_DEVIATION 2 | 3.0 μu/ml STANDARD_DEVIATION 2 |
| Resting Metabolic Rate | 1710 Kcal/d STANDARD_DEVIATION 974 | 1565 Kcal/d STANDARD_DEVIATION 689 | 1442 Kcal/d STANDARD_DEVIATION 348 |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Male | 4 Participants | 9 Participants | 5 Participants |
| Total Cholesterol | 167 mg/dl STANDARD_DEVIATION 49 | 172 mg/dl STANDARD_DEVIATION 38 | 176 mg/dl STANDARD_DEVIATION 29 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 7 | 0 / 6 |
| serious Total, serious adverse events | 0 / 7 | 0 / 6 |
Outcome results
Primary
%Body Fat Between Groups
Comparison of %body fat between the ACE and FESLCE groups following the 16 week intervention.
Time frame: 16 weeks
Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm Cycling Ergometer | %Body Fat Between Groups | 37.1 Percent Body Fat | Standard Deviation 5.6 |
| FESLCE | %Body Fat Between Groups | 39.9 Percent Body Fat | Standard Deviation 6.8 |
Comparison: We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise interventionp-value: >0.05Wilcoxon (Mann-Whitney)
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.
Time frame: baseline, 16 weeks
Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm Cycling Ergometer | Change in % Body Fat | -1.83 Percent Body Fat | Standard Deviation 2.72 |
| FESLCE | Change in % Body Fat | -1.68 Percent Body Fat | Standard Deviation 0.98 |
Comparison: We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group (i.e, baseline vs. post-intervention in ARE)p-value: >0.05t-test, 2 sided
Comparison: We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group (i.e, baseline vs. post-intervention in FESLCE)p-value: >0.05t-test, 2 sided
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.
Time frame: baseline, 16 weeks
Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm Cycling Ergometer | Change in Fat-Free Mass | 0.90 Kg | Standard Deviation 3.49 |
| FESLCE | Change in Fat-Free Mass | 1.86 Kg | Standard Deviation 2.42 |
Comparison: We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group.p-value: 0.519t-test, 2 sided
Comparison: We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE groupp-value: >0.05t-test, 2 sided
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.
Time frame: Baseline, 16 Weeks
Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm Cycling Ergometer | Change in Fat Mass | -1.84 Kg | Standard Deviation 1.99 |
| FESLCE | Change in Fat Mass | -1.02 Kg | Standard Deviation 2.55 |
Comparison: We evaluated differences between baseline and following the 16-week exercise intervention in the ACE groupp-value: >0.05t-test, 2 sided
Comparison: We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE groupp-value: >0.05t-test, 2 sided
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.
Time frame: Baseline, 16-weeks
Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm Cycling Ergometer | Change in Glucose Effectiveness (Sg) | 0.00 min^-1 | Standard Deviation 0.02 |
| FESLCE | Change in Glucose Effectiveness (Sg) | 0.01 min^-1 | Standard Deviation 0.01 |
Comparison: We evaluated differences between baseline and following the 16-week exercise intervention in the ACE groupp-value: 0.615t-test, 2 sided
Comparison: We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE groupp-value: >0.05t-test, 2 sided
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.
Time frame: Baseline, 16-weeks
Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm Cycling Ergometer | Change in Insulin Sensitivity (Si) | 10.1 min^-1 | Standard Deviation 25.3 |
| FESLCE | Change in Insulin Sensitivity (Si) | 5.28 min^-1 | Standard Deviation 12.4 |
Comparison: We evaluated differences between baseline and following the 16-week exercise intervention in the ACE groupp-value: >0.05t-test, 2 sided
Comparison: We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE groupp-value: >0.05t-test, 2 sided
Primary
Fat Free Mass Between Groups
Comparison of fat free mass between the ACE and FESLCE groups following the 16 week intervention.
Time frame: 16 weeks
Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm Cycling Ergometer | Fat Free Mass Between Groups | 50.5 kg | Standard Deviation 10.4 |
| FESLCE | Fat Free Mass Between Groups | 51.3 kg | Standard Deviation 12.8 |
Comparison: We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise interventionp-value: >0.05Wilcoxon (Mann-Whitney)
Primary
Fat Mass Between Groups
Comparison of fat mass between the ACE and FESLCE groups following the 16 week intervention.
Time frame: 16 weeks
Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm Cycling Ergometer | Fat Mass Between Groups | 29.6 kg | Standard Deviation 6.4 |
| FESLCE | Fat Mass Between Groups | 33.4 kg | Standard Deviation 11 |
Comparison: We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise interventionp-value: >0.05Wilcoxon (Mann-Whitney)
Primary
Glucose Effectiveness (Sg) Between Groups
Comparison of Sg between the ACE and FESLCE groups following the 16 week intervention.
Time frame: 16 weeks
Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm Cycling Ergometer | Glucose Effectiveness (Sg) Between Groups | .03 min^-1 | Standard Deviation 0.009 |
| FESLCE | Glucose Effectiveness (Sg) Between Groups | 0.02 min^-1 | Standard Deviation 0.009 |
Comparison: We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise interventionp-value: >0.05Wilcoxon (Mann-Whitney)
Primary
Insulin Sensitivity (Si) Between Groups
Comparison of Si between the ACE and FESLCE groups following the 16 week intervention.
Time frame: 16 weeks
Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm Cycling Ergometer | Insulin Sensitivity (Si) Between Groups | 13.7 min^-1 | Standard Deviation 0.02 |
| FESLCE | Insulin Sensitivity (Si) Between Groups | 8.4 min^-1 | Standard Deviation 12.9 |
Comparison: We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise interventionp-value: >0.05Wilcoxon (Mann-Whitney)
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.
Time frame: baseline, 16 weeks
Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm Cycling Ergometer | Change in High Density Lipoprotein Cholesterol (HDL) | -2.29 mg/dL | Standard Deviation 3.55 |
| FESLCE | Change in High Density Lipoprotein Cholesterol (HDL) | 0.07 mg/dL | Standard Deviation 2.63 |
Comparison: We evaluated differences between baseline and following the 16-week exercise intervention in the ACE groupp-value: >0.05t-test, 2 sided
Comparison: We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE groupp-value: >0.05t-test, 2 sided
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.
Time frame: baseline, 16 weeks
Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm Cycling Ergometer | Change in Low Density Lipoprotein Cholesterol (LDL) | 0.14 mg/dL | Standard Deviation 20.7 |
| FESLCE | Change in Low Density Lipoprotein Cholesterol (LDL) | 1.43 mg/dL | Standard Deviation 24.3 |
Comparison: We evaluated differences between baseline and following the 16-week exercise intervention in the ACE groupp-value: >0.05t-test, 2 sided
Comparison: We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE groupp-value: >0.05t-test, 2 sided
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.
Time frame: baseline, 16 weeks
Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm Cycling Ergometer | Change in Lower Limb Bone Mineral Content | -0.07 grams | Standard Deviation 0.14 |
| FESLCE | Change in Lower Limb Bone Mineral Content | -0.06 grams | Standard Deviation 0.09 |
Comparison: We evaluated differences between baseline and following the 16-week exercise intervention in the ACE groupp-value: >0.05t-test, 2 sided
Comparison: We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE groupp-value: >0.05t-test, 2 sided
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.
Time frame: baseline, 16 weeks
Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm Cycling Ergometer | Change in Lower Limb Bone Mineral Density | 0.02 g*(cm^2)^-1 | Standard Deviation 0.03 |
| FESLCE | Change in Lower Limb Bone Mineral Density | -0.01 g*(cm^2)^-1 | Standard Deviation 0.02 |
Comparison: We evaluated differences between baseline and following the 16-week exercise intervention in the ACE groupp-value: >0.05t-test, 2 sided
Comparison: We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE groupp-value: >0.05t-test, 2 sided
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.
Time frame: Baseline, 16 weeks
Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm Cycling Ergometer | Change in the Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL) | 0.24 Ratio | Standard Deviation 0.59 |
| FESLCE | Change in the Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL) | -0.22 Ratio | Standard Deviation 0.79 |
Comparison: We evaluated differences between baseline and following the 16-week exercise intervention in the ACE groupp-value: >0.05t-test, 2 sided
Comparison: We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE groupp-value: >0.05t-test, 2 sided
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.
Time frame: baseline, 16 weeks
Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm Cycling Ergometer | Change in Total Cholesterol (TC) | -1.14 mg/dL | Standard Deviation 22.6 |
| FESLCE | Change in Total Cholesterol (TC) | -12.33 mg/dL | Standard Deviation 8.19 |
Comparison: We evaluated differences between baseline and following the 16-week exercise intervention in the ACE groupp-value: >0.05t-test, 2 sided
Comparison: We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE groupp-value: >0.05t-test, 2 sided
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.
Time frame: baseline, 16 weeks
Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm Cycling Ergometer | Change in Triglycerides | -1.14 mg/dL | Standard Deviation 22.6 |
| FESLCE | Change in Triglycerides | -12.33 mg/dL | Standard Deviation 8.19 |
Comparison: We evaluated differences between baseline and following the 16-week exercise intervention in the ACE groupp-value: >0.05t-test, 2 sided
Comparison: We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE groupp-value: >0.05t-test, 2 sided
Secondary
High Density Lipoprotein Cholesterol (HDL) Between Groups
Comparison of HDL between the ACE and FESLCE groups following the 16 week intervention
Time frame: 16 weeks
Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm Cycling Ergometer | High Density Lipoprotein Cholesterol (HDL) Between Groups | 33.43 mg/dL | Standard Deviation 5.1 |
| FESLCE | High Density Lipoprotein Cholesterol (HDL) Between Groups | 37.8 mg/dL | Standard Deviation 8.3 |
Comparison: We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise interventionp-value: >0.05Wilcoxon (Mann-Whitney)
Secondary
Low Density Lipoprotein Cholesterol (LDL) Between Groups
Comparison of LDL between the ACE and FESLCE groups following the 16 week intervention
Time frame: 16 weeks
Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm Cycling Ergometer | Low Density Lipoprotein Cholesterol (LDL) Between Groups | 118.3 mg/dL | Standard Deviation 32.2 |
| FESLCE | Low Density Lipoprotein Cholesterol (LDL) Between Groups | 107.3 mg/dL | Standard Deviation 35.2 |
Comparison: We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise interventionp-value: >0.05Wilcoxon (Mann-Whitney)
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
Time frame: 16 weeks
Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm Cycling Ergometer | Lower Limb Bone Mineral Content Between Groups | 3.37 grams | Standard Deviation 0.64 |
| FESLCE | Lower Limb Bone Mineral Content Between Groups | 2.88 grams | Standard Deviation 0.55 |
Comparison: We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise interventionp-value: >0.05Wilcoxon (Mann-Whitney)
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
Time frame: 16 weeks
Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm Cycling Ergometer | Lower Limb Bone Mineral Density Between Groups | 1.15 g*(cm^2)^-1 | Standard Deviation 0.12 |
| FESLCE | Lower Limb Bone Mineral Density Between Groups | 1.28 g*(cm^2)^-1 | Standard Deviation 0.12 |
Comparison: We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise interventionp-value: >0.05Wilcoxon (Mann-Whitney)
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
Time frame: 16 weeks
Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm Cycling Ergometer | Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL) Between Groups | 5.3 Ratio | Standard Deviation 1.4 |
| FESLCE | Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL) Between Groups | 4.5 Ratio | Standard Deviation 1.4 |
Comparison: We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise interventionp-value: >0.05Wilcoxon (Mann-Whitney)
Secondary
Total Cholesterol (TC) Between Groups
Comparison of TC between the ACE and FESLCE groups following the 16 week intervention
Time frame: 16 weeks
Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm Cycling Ergometer | Total Cholesterol (TC) Between Groups | 172.0 mg/dL | Standard Deviation 28.6 |
| FESLCE | Total Cholesterol (TC) Between Groups | 163.7 mg/dL | Standard Deviation 38.9 |
Comparison: we evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise interventionp-value: >0.05Wilcoxon (Mann-Whitney)
Secondary
Triglycerides Between Groups
Comparison of Triglycerides between the ACE and FESLCE groups following the 16 week intervention
Time frame: 16 weeks
Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm Cycling Ergometer | Triglycerides Between Groups | 87.33 mg/dL | Standard Deviation 46.7 |
| FESLCE | Triglycerides Between Groups | 103.6 mg/dL | Standard Deviation 65.16 |
Comparison: We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise interventionp-value: >0.05Wilcoxon (Mann-Whitney)
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.
Time frame: baseline, 16 weeks
Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm Cycling Ergometer | Change in Resting Metabolic Rate | -131.7 kcal/day | Standard Deviation 393 |
| FESLCE | Change in Resting Metabolic Rate | -322.0 kcal/day | Standard Deviation 963 |
Comparison: We evaluated differences between baseline and following the 16-week exercise intervention in the ACE groupp-value: >0.05t-test, 2 sided
Comparison: We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE groupp-value: >0.05t-test, 2 sided
Other Pre-specified
Resting Metabolic Rate Between Groups
Comparison of resting metabolic rate between the ACE and FESLCE groups following the 16 week intervention
Time frame: 16 weeks
Population: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm Cycling Ergometer | Resting Metabolic Rate Between Groups | 1309.06 kcal/day | Standard Deviation 167.9 |
| FESLCE | Resting Metabolic Rate Between Groups | 1387.8 kcal/day | Standard Deviation 392.3 |
Comparison: We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise interventionp-value: >0.05Wilcoxon (Mann-Whitney)