Exercise to Reduce Obesity in Spinal Cord Injury

NCT00270855 | Completed Results

• 2 other identifiers: B3918-RUL1RR031990
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Body Composition; Exercise; Glucose Tolerance; Insulin Sensitivity; Functional Electric Stimulation

Outcome Measures

Primary Outcomes (10)

• 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.

  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

Secondary Outcomes (14)

• Change in Lower Limb Bone Mineral Density

  baseline, 16 weeks

• Change in Lower Limb Bone Mineral Content

  baseline, 16 weeks

• Change in Triglycerides

  baseline, 16 weeks

• Change in High Density Lipoprotein Cholesterol (HDL)

  baseline, 16 weeks

• Change in Low Density Lipoprotein Cholesterol (LDL)

  baseline, 16 weeks

Other Outcomes (2)

• Change in Resting Metabolic Rate

  baseline, 16 weeks

• Resting Metabolic Rate Between Groups

  16 weeks

Study Arms (2)

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

Procedure: Arm Crank Ergometry

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

Procedure: FES Cycle Ergometer

Interventions

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

Arm Crank Ergometer

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

FESLCE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Obesity; Paraplegia; Quadriplegia; Spinal Cord Injuries; Motor Activity; Insulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Paralysis; Neurologic Manifestations; Nervous System Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Behavior; Hyperinsulinism

Limitations and Caveats

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

Results Point of Contact

• Title: Dr. David Gater
• Organization: Penn State Hershey Medical Center

dgater@hmc.psu.edu

7175314263

Study Officials

• David R Gater, MD PhD MS

  Hunter Holmes McGuire VA Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2005
• First Posted: December 28, 2005
• Study Start: May 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: December 1, 2011
• Last Updated: November 17, 2017
• Results First Posted: November 17, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)