Spinal Injuries
Conditions
Brief summary
The purpose of this research is to test the health benefits of using functional electrical stimulation for lower extremity exercise at home.
Detailed description
The specific objectives are to assess the impact of 16 weeks of home-based telemonitored functional electrical stimulation leg cycle ergometry (FESLCE) exercise on body composition and metabolic health in adults with C4-T4 motor complete SCI. This study is available only to those who were previously enrolled in the SCIENCE protocol #20190659 that were randomized to the diet alone group. After completing the dietary intervention, those individuals will have an opportunity to experience FES bicycle.
Interventions
OTHERSpinal Cord Injury Exercise Group
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.
Sponsors
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in percent body fat | Baseline, 20 weeks (Post Intervention) | Percent body fat will be assessed using Dual Energy x-ray absorbency (DXA) |
| Change in percent visceral fat | Baseline, 20 weeks (Post Intervention) | Percent visceral fat will be assessed using DXA |
| Change in percent of lean body mass | Baseline, 20 weeks (Post Intervention) | Percent lean body mass will be assessed using DXA |
| Change in percent of fat free mass | Baseline, 20 weeks (Post Intervention) | Percent fat free mass will be assessed using DXA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Insulin levels | Baseline, 20 weeks (Post Intervention) | Insulin levels will be assessed using blood samples |
| Change in glucose levels | Baseline, 20 weeks (Post Intervention) | Glucose will be measured in mg/dL using blood samples |
| Change in hsCRP levels | Baseline, 20 weeks (Post Intervention) | High sensitivity C Reactive Protein (hsCRP) will be assessed using blood samples |
| Change in HgbA1C levels | Baseline, 20 weeks (Post Intervention) | Hemoglobin A1c (HgbA1c) levels will be assessed using blood samples |
| Change in Lipid Panel values | Baseline, 20 weeks (Post Intervention) | 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 |
| Change in resting metabolic rate | Baseline, 20 weeks (Post Intervention) | 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 |
Countries
United States
Outcome results
None listed