Telemonitored Exercise to Attenuate Metabolic Dysregulation in Spinal Cord Injury

Study Overview
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Brief Summary
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The purpose of this research is to test the health benefits of using functional electrical stimulation for lower extremity exercise at home.

Official Title
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Telemonitored Exercise to Attenuate Metabolic Dysregulation in Spinal Cord Injury (TEAM-SCI)

Conditions
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Spinal Injuries

Intervention / Treatment
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* Other: Spinal Cord Injury Exercise Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women of child-bearing potential who agree to refrain from getting pregnant during the trial Previously enrolled in the SCIENCE protocol (NCT03495986) randomized to the diet alone group in SCIENCE, and are willing to complete an 8-week (2 month) washout period after the completion of the dietary intervention in the study. Exclusion Criteria: Do not meet inclusion criteria above Those who have participated in a Functional Electrical Stimulation (FES) or ACE exercise program (>60 minutes/week) within the past 3 months Self-reported or documented history of: orthopedic limitations coronary artery disease type 1 diabetes mellitus; insulin-requiring Type 2 diabetes mellitus; untreated Type 2 diabetes mellitus untreated hypothyroidism renal disease uncontrolled autonomic dysreflexia, recent (within 3 months) deep vein thrombosis (within the past 3 months) On anticoagulation therapy Pressure injuries > Grade II Decisional impairment Prisoners Pregnant or nursing women Any potential causes of autonomic dysreflexia at the discretion of the PI

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spinal Cord Injury Exercise Group<br>Participants will exercise at home 3-5 times per week under supervision via teleconference. Participants will be part of this group for 18-20 weeks. | Other: Spinal Cord Injury Exercise Group<br>* Participants will have an initial accommodation period of 4 weeks, during which four 10-minute exercise bouts/day will be interspersed with 5 minutes of rest. The bouts will gradually increase until at least continuous 40-minute sessions. The remaining 12-week intervention will be set at 70% max heart rate for a total of 16 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in percent body fat | Percent body fat will be assessed using Dual Energy x-ray absorbency (DXA) | Baseline, 20 weeks (Post Intervention) | 
| Change in percent visceral fat | Percent visceral fat will be assessed using DXA | Baseline, 20 weeks (Post Intervention) | 
| Change in percent of lean body mass | Percent lean body mass will be assessed using DXA | Baseline, 20 weeks (Post Intervention) | 
| Change in percent of fat free mass | Percent fat free mass will be assessed using DXA | Baseline, 20 weeks (Post Intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Lipid Panel values | Lipid panel values including High Density Lipoprotein, Low Density Lipoprotein, Total Cholesterol and triglycerides, all assessed in mg/dL, will be measured from blood samples | Baseline, 20 weeks (Post Intervention) | 
| Change in resting metabolic rate | Change in resting metabolic rate will be measured by using a large clear plastic dome over the head and the air exhaled will be measured | Baseline, 20 weeks (Post Intervention) | 
| Change in glucose levels | Glucose will be measured in mg/dL using blood samples | Baseline, 20 weeks (Post Intervention) | 
| Change in HgbA1C levels | Hemoglobin A1c (HgbA1c) levels will be assessed using blood samples | Baseline, 20 weeks (Post Intervention) | 
| Change in Insulin levels | Insulin levels will be assessed using blood samples | Baseline, 20 weeks (Post Intervention) | 
| Change in hsCRP levels | High sensitivity C Reactive Protein (hsCRP) will be assessed using blood samples | Baseline, 20 weeks (Post Intervention) |