Exercise to Reduce Obesity in Spinal Cord Injury

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00270855
• Collaborator: National Center for Research Resources (NCRR) (NIH)
• Enrollment: 29
• Location: 1
• Arms: 2
• Duration (Months): 43
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus; Obesity; Paraplegia; Quadriplegia; Spinal Cord Injury	Procedure: Arm Crank Ergometry; Procedure: FES Cycle Ergometer	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 29 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Exercise to Reduce Obesity in Spinal Cord Injury
• Study Start Date: May 1, 2008
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: Arm Crank Ergometer Upper body Cycle ergometer Exercise: 10-minute warm up, 40 minutes @ 70%HRMax (50RPM), 10 minute cool down 5x/week x 16 weeks	Procedure: Arm 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
Other: FESLCE 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	Procedure: FES 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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. %Body Fat Between Groups [16 weeks]

   Comparison of %body fat between the ACE and FESLCE groups following the 16 week intervention.

7. Fat Mass Between Groups [16 weeks]

   Comparison of fat mass between the ACE and FESLCE groups following the 16 week intervention.

8. Fat Free Mass Between Groups [16 weeks]

   Comparison of fat free mass between the ACE and FESLCE groups following the 16 week intervention.

9. Insulin Sensitivity (Si) Between Groups [16 weeks]

   Comparison of Si between the ACE and FESLCE groups following the 16 week intervention.

10. Glucose Effectiveness (Sg) Between Groups [16 weeks]

    Comparison of Sg between the ACE and FESLCE groups following the 16 week intervention.

Secondary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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

9. 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

10. Triglycerides Between Groups [16 weeks]

    Comparison of Triglycerides between the ACE and FESLCE groups following the 16 week intervention

11. High Density Lipoprotein Cholesterol (HDL) Between Groups [16 weeks]

    Comparison of HDL between the ACE and FESLCE groups following the 16 week intervention

12. Low Density Lipoprotein Cholesterol (LDL) Between Groups [16 weeks]

    Comparison of LDL between the ACE and FESLCE groups following the 16 week intervention

13. Total Cholesterol (TC) Between Groups [16 weeks]

    Comparison of TC between the ACE and FESLCE groups following the 16 week intervention

14. 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

Other Outcome Measures

1. 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.

2. Resting Metabolic Rate Between Groups [16 weeks]

   Comparison of resting metabolic rate between the ACE and FESLCE groups following the 16 week intervention

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hunter Holmes McGuire VA Medical Center	Richmond	Virginia	United States	23249

Sponsors and Collaborators

• VA Office of Research and Development
• National Center for Research Resources (NCRR)

Investigators

• Principal Investigator: David R Gater, MD PhD MS, Hunter Holmes McGuire VA Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT00270855
• Other Study ID Numbers: B3918-R; UL1RR031990
• First Posted: Dec 28, 2005
• Last Update Posted: Nov 17, 2017
• Last Verified: Oct 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by VA Office of Research and Development: Body Composition; Exercise; Glucose Tolerance; Insulin Sensitivity; Functional Electric Stimulation
• Additional relevant MeSH terms: Spinal Cord Injuries; Paraplegia; Quadriplegia; Obesity; Wounds and Injuries

Study Results

Participant Flow

Arm/Group Title	Arm Crank Ergometer	FESLCE
Arm/Group Description	Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Period Title: Overall Study
STARTED	15	14
COMPLETED	7	6
NOT COMPLETED	8	8

Baseline Characteristics

Arm/Group Title	Arm Cycling Ergometer	FESLCE	Total
Arm/Group Description	Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise	Total of all reporting groups
Overall Participants	7	6	13
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	42 (10)	39 (14)	40.5 (12)
Sex: Female, Male (Count of Participants)
Female	2 28.6%	2 33.3%	4 30.8%
Male	5 71.4%	4 66.7%	9 69.2%
% Body Fat (Percent Body Fat) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Percent Body Fat]	38.9 (6.9)	41.6 (7.1)	40.75 (7.4)
Fat Mass (Kg) (Kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kg]	29.6 (6.4)	33.4 (11.0)	31.5 (8.7)
Fat-Free Mass (kg) (Kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kg]	49.6 (9.1)	49.5 (11.2)	49.55 (10.15)
Glucose Effectiveness (Sg) (min^-1) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [min^-1]	0.023 (0.01)	0.017 (0.01)	0.02 (0.01)
Insulin Sensitivity (Si) (μu/ml) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [μu/ml]	3.0 (2.0)	2.7 (2.0)	2.85 (2)
Exercise Energy Expenditure (Kcal/session) (Kcal/session) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kcal/session]	128.3 (35.4)	80.7 (32.6)	101 (34)
Resting Metabolic Rate (Kcal/d) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kcal/d]	1442 (348)	1710 (974)	1565 (689)
Total Cholesterol (mg/dl) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dl]	176 (29)	167 (49)	172 (38)
HDL-Cholesterol (mg/dl) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dl]	35.7 (6.4)	37.8 (8.3)	36.7 (7.1)
Bone Mineral Density (g/cm^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [g/cm^2]	1.138 (0.104)	1.293 (0.135)	1.209 (0.140)

Outcome Measures

1. Primary Outcome

Title	Change in % Body Fat
Description	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

Outcome Measure Data

Analysis Population Description

Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Arm/Group Title	Arm Cycling Ergometer	FESLCE
Arm/Group Description	Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Measure Participants	7	6
Mean (Standard Deviation) [Percent Body Fat]	-1.83 (2.72)	-1.68 (0.98)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm Cycling Ergometer
	Comments	We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group (i.e, baseline vs. post-intervention in ARE)
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A Wilcoxon signed-rank test was performed.
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	FESLCE
	Comments	We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group (i.e, baseline vs. post-intervention in FESLCE)
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A Wilcoxon signed-rank test was performed.
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	t-test, 2 sided
	Comments

2. Primary Outcome

Title	Change in Fat Mass
Description	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

Outcome Measure Data

Analysis Population Description

Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Arm/Group Title	Arm Cycling Ergometer	FESLCE
Arm/Group Description	Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Measure Participants	7	6
Mean (Standard Deviation) [Kg]	-1.84 (1.99)	-1.02 (2.55)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm Cycling Ergometer
	Comments	We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A Wilcoxon signed-rank test was performed.
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	FESLCE
	Comments	We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A Wilcoxon signed-rank test was performed.
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	t-test, 2 sided
	Comments

3. Primary Outcome

Title	Change in Fat-Free Mass
Description	Fat-Free Mass (kg). Change score was calculated as final value (i.e., post intervention variable) minus baseline value.
Time Frame	baseline, 16 weeks

Outcome Measure Data

Analysis Population Description

Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Arm/Group Title	Arm Cycling Ergometer	FESLCE
Arm/Group Description	Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Measure Participants	7	6
Mean (Standard Deviation) [Kg]	0.90 (3.49)	1.86 (2.42)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm Cycling Ergometer
	Comments	We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A Wilcoxon signed-rank test was performed.
Statistical Test of Hypothesis	p-Value	0.519
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	FESLCE
	Comments	We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A Wilcoxon signed-rank test was performed.
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	t-test, 2 sided
	Comments

4. Primary Outcome

Title	Change in Glucose Effectiveness (Sg)
Description	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

Outcome Measure Data

Analysis Population Description

Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Arm/Group Title	Arm Crank Ergometer	FESLCE
Arm/Group Description	Upper body Cycle ergometer Exercise: 10-minute warm up, 40 minutes @ 70%HRMax (50RPM), 10 minute cool down 5x/week x 16 weeks Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	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 FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Measure Participants	7	6
Mean (Standard Deviation) [min^-1]	0.00 (0.02)	0.01 (0.01)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm Cycling Ergometer
	Comments	We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A Wilcoxon signed-rank test was performed.
Statistical Test of Hypothesis	p-Value	0.615
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	FESLCE
	Comments	We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A Wilcoxon signed-rank test was performed.
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	t-test, 2 sided
	Comments

5. Primary Outcome

Title	Change in Insulin Sensitivity (Si)
Description	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

Outcome Measure Data

Analysis Population Description

Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Arm/Group Title	Arm Crank Ergometer	FESLCE
Arm/Group Description	Upper body Cycle ergometer Exercise: 10-minute warm up, 40 minutes @ 70%HRMax (50RPM), 10 minute cool down 5x/week x 16 weeks Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	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 FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Measure Participants	7	6
Mean (Standard Deviation) [min^-1]	10.1 (25.3)	5.28 (12.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm Cycling Ergometer
	Comments	We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A Wilcoxon signed-rank test was performed.
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	FESLCE
	Comments	We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A Wilcoxon signed-rank test was performed.
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	t-test, 2 sided
	Comments

6. Primary Outcome

Title	%Body Fat Between Groups
Description	Comparison of %body fat between the ACE and FESLCE groups following the 16 week intervention.
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Arm/Group Title	Arm Cycling Ergometer	FESLCE
Arm/Group Description	Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Measure Participants	7	6
Mean (Standard Deviation) [Percent Body Fat]	37.1 (5.6)	39.9 (6.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm Cycling Ergometer, FESLCE
	Comments	We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A Mann-Whitney-u test was performed.
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

7. Primary Outcome

Title	Fat Mass Between Groups
Description	Comparison of fat mass between the ACE and FESLCE groups following the 16 week intervention.
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Arm/Group Title	Arm Cycling Ergometer	FESLCE
Arm/Group Description	Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Measure Participants	7	6
Mean (Standard Deviation) [kg]	29.6 (6.4)	33.4 (11.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm Cycling Ergometer, FESLCE
	Comments	We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A Mann-Whitney-u test was performed.
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

8. Primary Outcome

Title	Fat Free Mass Between Groups
Description	Comparison of fat free mass between the ACE and FESLCE groups following the 16 week intervention.
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Arm/Group Title	Arm Cycling Ergometer	FESLCE
Arm/Group Description	Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Measure Participants	7	6
Mean (Standard Deviation) [kg]	50.5 (10.4)	51.3 (12.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm Cycling Ergometer, FESLCE
	Comments	We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A Mann-Whitney-u test was performed.
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

9. Primary Outcome

Title	Insulin Sensitivity (Si) Between Groups
Description	Comparison of Si between the ACE and FESLCE groups following the 16 week intervention.
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Arm/Group Title	Arm Cycling Ergometer	FESLCE
Arm/Group Description	Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Measure Participants	7	6
Mean (Standard Deviation) [min^-1]	13.7 (0.02)	8.4 (12.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm Cycling Ergometer, FESLCE
	Comments	We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A Mann-Whitney-u test was performed.
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

10. Primary Outcome

Title	Glucose Effectiveness (Sg) Between Groups
Description	Comparison of Sg between the ACE and FESLCE groups following the 16 week intervention.
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Arm/Group Title	Arm Cycling Ergometer	FESLCE
Arm/Group Description	Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Measure Participants	7	6
Mean (Standard Deviation) [min^-1]	.03 (0.009)	0.02 (0.009)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm Cycling Ergometer, FESLCE
	Comments	We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A Mann-Whitney-u test was performed
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

11. Secondary Outcome

Title	Change in Lower Limb Bone Mineral Density
Description	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

Outcome Measure Data

Analysis Population Description

Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Arm/Group Title	Arm Cycling Ergometer	FESLCE
Arm/Group Description	Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Measure Participants	7	6
Mean (Standard Deviation) [g*(cm^2)^-1]	0.02 (0.03)	-0.01 (0.02)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm Cycling Ergometer
	Comments	We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A Wilcoxon signed-rank test was performed.
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	FESLCE
	Comments	We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A Wilcoxon signed-rank test was performed.
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	t-test, 2 sided
	Comments

12. Secondary Outcome

Title	Change in Lower Limb Bone Mineral Content
Description	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

Outcome Measure Data

Analysis Population Description

Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Arm/Group Title	Arm Cycling Ergometer	FESLCE
Arm/Group Description	Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Measure Participants	7	6
Mean (Standard Deviation) [grams]	-0.07 (0.14)	-0.06 (0.09)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm Cycling Ergometer
	Comments	We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A Wilcoxon signed-rank test was performed.
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	FESLCE
	Comments	We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A Wilcoxon signed-rank test was performed.
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	t-test, 2 sided
	Comments

13. Secondary Outcome

Title	Change in Triglycerides
Description	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

Outcome Measure Data

Analysis Population Description

Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Arm/Group Title	Arm Cycling Ergometer	FESLCE
Arm/Group Description	Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Measure Participants	7	6
Mean (Standard Deviation) [mg/dL]	-1.14 (22.6)	-12.33 (8.19)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm Cycling Ergometer
	Comments	We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Wilcoxon signed-rank test was performed
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	FESLCE
	Comments	We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A Wilcoxon signed-rank test was performed.
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	t-test, 2 sided
	Comments

14. Secondary Outcome

Title	Change in High Density Lipoprotein Cholesterol (HDL)
Description	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

Outcome Measure Data

Analysis Population Description

Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Arm/Group Title	Arm Cycling Ergometer	FESLCE
Arm/Group Description	Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Measure Participants	7	6
Mean (Standard Deviation) [mg/dL]	-2.29 (3.55)	0.07 (2.63)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm Cycling Ergometer
	Comments	We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A Wilcoxon signed-rank test was performed
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	FESLCE
	Comments	We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A Wilcoxon signed-rank test was performed.
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	t-test, 2 sided
	Comments

15. Secondary Outcome

Title	Change in Low Density Lipoprotein Cholesterol (LDL)
Description	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

Outcome Measure Data

Analysis Population Description

Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Arm/Group Title	Arm Cycling Ergometer	FESLCE
Arm/Group Description	Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Measure Participants	7	6
Mean (Standard Deviation) [mg/dL]	0.14 (20.7)	1.43 (24.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm Cycling Ergometer
	Comments	We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A Wilcoxon signed-rank test was performed
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	FESLCE
	Comments	We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A Wilcoxon signed-rank test was performed.
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	t-test, 2 sided
	Comments

16. Secondary Outcome

Title	Change in Total Cholesterol (TC)
Description	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

Outcome Measure Data

Analysis Population Description

Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Arm/Group Title	Arm Cycling Ergometer	FESLCE
Arm/Group Description	Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Measure Participants	7	6
Mean (Standard Deviation) [mg/dL]	-1.14 (22.6)	-12.33 (8.19)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm Cycling Ergometer
	Comments	We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A Wilcoxon signed-rank test was performed
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	FESLCE
	Comments	We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A Wilcoxon signed-rank test was performed.
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	t-test, 2 sided
	Comments

17. Secondary Outcome

Title	Change in the Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL)
Description	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

Outcome Measure Data

Analysis Population Description

Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Arm/Group Title	Arm Cycling Ergometer	FESLCE
Arm/Group Description	Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Measure Participants	7	6
Mean (Standard Deviation) [Ratio]	0.24 (0.59)	-0.22 (0.79)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm Cycling Ergometer
	Comments	We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A Wilcoxon signed-rank test was performed
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	FESLCE
	Comments	We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A Wilcoxon signed-rank test was performed.
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	t-test, 2 sided
	Comments

18. Secondary Outcome

Title	Lower Limb Bone Mineral Density Between Groups
Description	Comparison of Lower limb bone mineral density between the ACE and FESLCE groups following the 16 week intervention
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Arm/Group Title	Arm Cycling Ergometer	FESLCE
Arm/Group Description	Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Measure Participants	7	6
Mean (Standard Deviation) [g*(cm^2)^-1]	1.15 (0.12)	1.28 (0.12)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm Cycling Ergometer, FESLCE
	Comments	We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A Mann-Whitney-u test was performed.
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

19. Secondary Outcome

Title	Lower Limb Bone Mineral Content Between Groups
Description	Comparison of Lower limb bone mineral content between the ACE and FESLCE groups following the 16 week intervention
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Arm/Group Title	Arm Cycling Ergometer	FESLCE
Arm/Group Description	Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Measure Participants	7	6
Mean (Standard Deviation) [grams]	3.37 (0.64)	2.88 (0.55)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm Cycling Ergometer, FESLCE
	Comments	We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A Mann-Whitney-u test was performed
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

20. Secondary Outcome

Title	Triglycerides Between Groups
Description	Comparison of Triglycerides between the ACE and FESLCE groups following the 16 week intervention
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Arm/Group Title	Arm Cycling Ergometer	FESLCE
Arm/Group Description	Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Measure Participants	7	6
Mean (Standard Deviation) [mg/dL]	87.33 (46.7)	103.6 (65.16)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm Cycling Ergometer, FESLCE
	Comments	We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A Mann-Whitney-u test was performed
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

21. Secondary Outcome

Title	High Density Lipoprotein Cholesterol (HDL) Between Groups
Description	Comparison of HDL between the ACE and FESLCE groups following the 16 week intervention
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Arm/Group Title	Arm Cycling Ergometer	FESLCE
Arm/Group Description	Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Measure Participants	7	6
Mean (Standard Deviation) [mg/dL]	33.43 (5.1)	37.8 (8.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm Cycling Ergometer, FESLCE
	Comments	We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A Mann-Whitney-u test was performed
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

22. Secondary Outcome

Title	Low Density Lipoprotein Cholesterol (LDL) Between Groups
Description	Comparison of LDL between the ACE and FESLCE groups following the 16 week intervention
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Arm/Group Title	Arm Cycling Ergometer	FESLCE
Arm/Group Description	Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Measure Participants	7	6
Mean (Standard Deviation) [mg/dL]	118.3 (32.2)	107.3 (35.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm Cycling Ergometer, FESLCE
	Comments	We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention
	Type of Statistical Test	Other
	Comments	A Mann-Whitney U test was performed.
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

23. Secondary Outcome

Title	Total Cholesterol (TC) Between Groups
Description	Comparison of TC between the ACE and FESLCE groups following the 16 week intervention
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Arm/Group Title	Arm Cycling Ergometer	FESLCE
Arm/Group Description	Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Measure Participants	7	6
Mean (Standard Deviation) [mg/dL]	172.0 (28.6)	163.7 (38.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm Cycling Ergometer, FESLCE
	Comments	we evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	We used a Mann-Whitney U test.
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

24. Secondary Outcome

Title	Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL) Between Groups
Description	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

Outcome Measure Data

Analysis Population Description

Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Arm/Group Title	Arm Cycling Ergometer	FESLCE
Arm/Group Description	Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Measure Participants	7	6
Mean (Standard Deviation) [Ratio]	5.3 (1.4)	4.5 (1.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm Cycling Ergometer, FESLCE
	Comments	We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A mann-whitney u test was performed.
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

25. Other Pre-specified Outcome

Title	Change in Resting Metabolic Rate
Description	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

Outcome Measure Data

Analysis Population Description

Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Arm/Group Title	Arm Cycling Ergometer	FESLCE
Arm/Group Description	Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Measure Participants	7	6
Mean (Standard Deviation) [kcal/day]	-131.7 (393)	-322.0 (963)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm Cycling Ergometer
	Comments	We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A Wilcoxon signed-rank test was performed.
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	FESLCE
	Comments	We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A Wilcoxon signed-rank test was performed.
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	t-test, 2 sided
	Comments

26. Other Pre-specified Outcome

Title	Resting Metabolic Rate Between Groups
Description	Comparison of resting metabolic rate between the ACE and FESLCE groups following the 16 week intervention
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Arm/Group Title	Arm Cycling Ergometer	FESLCE
Arm/Group Description	Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.	Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
Measure Participants	7	6
Mean (Standard Deviation) [kcal/day]	1309.06 (167.9)	1387.8 (392.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm Cycling Ergometer, FESLCE
	Comments	We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A Mann-Whitney U test was performed.
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Arm/Group Title	Arm Cycling Ergometer		FESLCE
Arm/Group Description	Upper body Cycle ergometer Arm Crank Ergometry: Use of an upper body cycle to perform exercise.		Functional Electrical Stimulation Cycle Ergometer for Lower body FES Cycle Ergometer: Use of an FES cycle ergometer to perform exercise
All Cause Mortality
	Arm Cycling Ergometer		FESLCE
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm Cycling Ergometer		FESLCE
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	Arm Cycling Ergometer		FESLCE
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/6 (0%)

Limitations/Caveats

The number of subjects that withdrew lead to small numbers of subjects analyzed.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.