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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal Cord Injury Exercise Group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Cord Injury Exercise Group | Other | 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. |
| 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) |
| 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 |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Eduard Tiozzo, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Christine E. Lynn Rehabilitation Center | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D013124 | Spinal Injuries |
| ID | Term |
|---|---|
| D019567 | Back Injuries |
| D014947 | Wounds and Injuries |
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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) |