Telemonitored Exercise to Attenuate Metabolic Dysregulation in Spinal Cord Injury
- Conditions
- Spinal Injuries
- Interventions
- Other: Spinal Cord Injury Exercise Group
- Registration Number
- NCT05597176
- Lead Sponsor
- University of Miami
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4
- 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.
-
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
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Any potential causes of autonomic dysreflexia at the discretion of the PI
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Spinal Cord Injury Exercise Group Spinal Cord Injury Exercise Group 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.
- Primary Outcome Measures
Name Time Method Change in percent of lean body mass Baseline, 20 weeks (Post Intervention) Percent lean body mass will be assessed using DXA
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 fat free mass Baseline, 20 weeks (Post Intervention) Percent fat free mass will be assessed using DXA
- Secondary Outcome Measures
Name Time Method 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 glucose levels Baseline, 20 weeks (Post Intervention) Glucose will be measured in mg/dL using blood samples
Change in Insulin levels Baseline, 20 weeks (Post Intervention) Insulin levels will be assessed 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 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
Trial Locations
- Locations (1)
University of Miami Christine E. Lynn Rehabilitation Center
🇺🇸Miami, Florida, United States