N/A N=29 Randomized Treatment

Exercise to Reduce Obesity in Spinal Cord Injury

Diabetes Mellitus · Obesity · Paraplegia · Quadriplegia · Spinal Cord Injury

Bottom Line

View on ClinicalTrials.gov: NCT00270855 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2017

Primary outcome: Primary: Change in % Body Fat — -1.83; -1.68 Percent Body Fat — p=>0.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Arm Crank Ergometry (Procedure); FES Cycle Ergometer (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Jun 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in % Body Fat	-1.83; -1.68	>0.05
PRIMARY Change in Fat Mass	-1.84; -1.02	>0.05
PRIMARY Change in Fat-Free Mass	0.90; 1.86	0.519
PRIMARY Change in Glucose Effectiveness (Sg)	0.00; 0.01	0.615
PRIMARY Change in Insulin Sensitivity (Si)	10.1; 5.28	>0.05
PRIMARY %Body Fat Between Groups	37.1; 39.9	>0.05
PRIMARY Fat Mass Between Groups	29.6; 33.4	>0.05
PRIMARY Fat Free Mass Between Groups	50.5; 51.3	>0.05
PRIMARY Insulin Sensitivity (Si) Between Groups	13.7; 8.4	>0.05
PRIMARY Glucose Effectiveness (Sg) Between Groups	.03; 0.02	>0.05
SECONDARY Change in Lower Limb Bone Mineral Density	0.02; -0.01	>0.05
SECONDARY Change in Lower Limb Bone Mineral Content	-0.07; -0.06	>0.05
SECONDARY Change in Triglycerides	-1.14; -12.33	>0.05
SECONDARY Change in High Density Lipoprotein Cholesterol (HDL)	-2.29; 0.07	>0.05
SECONDARY Change in Low Density Lipoprotein Cholesterol (LDL)	0.14; 1.43	>0.05
SECONDARY Change in Total Cholesterol (TC)	-1.14; -12.33	>0.05
SECONDARY Change in the Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL)	0.24; -0.22	>0.05
SECONDARY Lower Limb Bone Mineral Density Between Groups	1.15; 1.28	>0.05
SECONDARY Lower Limb Bone Mineral Content Between Groups	3.37; 2.88	>0.05
SECONDARY Triglycerides Between Groups	87.33; 103.6	>0.05
SECONDARY High Density Lipoprotein Cholesterol (HDL) Between Groups	33.43; 37.8	>0.05
SECONDARY Low Density Lipoprotein Cholesterol (LDL) Between Groups	118.3; 107.3	>0.05
SECONDARY Total Cholesterol (TC) Between Groups	172.0; 163.7	>0.05
SECONDARY Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL) Between Groups	5.3; 4.5	>0.05

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.

Eligibility Criteria

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.

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Data sourced from ClinicalTrials.gov (NCT00270855). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.