FES Cycling and Nutritional Counseling for Battling Obesity After SCI
Public ClinicalTrials.gov record NCT03810963. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
Electrically Induced Cycling and Nutritional Counseling for Counteracting Obesity After SCI
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Individuals who suffer from paralysis after spinal cord injury (SCI) are estimated to have an even greater (66%) prevalence of obesity. Obesity is a major public health concern and is associated with a plethora of cardiometabolic health complications (heart disease, stroke and type II diabetes mellitus). Although the benefits of physical activity to counteract obesity and cardiometabolic disease have been documented, SCI typically limits voluntary exercise to the often injured arms (60-90%). On the other hand, functional electrical stimulation (FES) cycling has proven to be a safe and effective way to exercise paralyzed leg muscles in clinical and home settings, saving the often overworked arms. The investigators have developed a novel high-intensity interval training (HIIT) protocol for FES lower extremities cycling that may provide equal or greater benefits with less time commitment. The investigators proof-of-principle study in 3 obese persons with SCI confirmed that HIIT-FES cycling 3 times per week for 8 weeks without dietary monitoring can increase legs lean mass (5-9%), increase cardiovascular health markers (58% on average) and decrease HbA1c blood levels (2-4%). Also, 2 persons decreased body weight and BMI. The investigators hypothesize that combining HIIT-FES cycling with nutritional counseling will be effective for reducing obesity and enhancing cardiometabolic health in persons with chronic SCI. Research AIM: To determine preliminary efficacy of HIIT-FES cycling combined with nutritional counseling in obese adults with SCI. In this pilot two-arm, parallel, pre-post, subject-matched controlled trial, we will test the hypothesis that the experimental group receiving HIIT-FES cycling plus nutritional counseling will decrease total body weight, decrease body fat percentage, decrease fat mass, increase total and legs lean mass, improve blood lipid levels, decrease blood glucose and HbA1c levels and improve vascular endothelial health (flow mediated dilation) significantly more than age-, sex- and injury-matched controls receiving nutritional counseling only. The investigators will recruit 20 obese adults, 21-65 years of age, with chronic post-traumatic SCI ranging in neurological level between C4 and T12. Participants will be divided into experimental (HIIT-FES cycling plus nutritional counseling) and control (nutritional counseling only) groups.
Study identification
- NCT ID
- NCT03810963
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 15 participants
Conditions and interventions
Conditions
Interventions
- HIIT-FES Cycling combined with Nutritional Counseling Combination Product
- Nutritional Counseling Only Other
Combination Product · Other
Eligibility (public fields only)
- Age range
- 21 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2017
- Primary completion
- Apr 30, 2019
- Completion
- Apr 30, 2019
- Last update posted
- Oct 3, 2019
2017 – 2019
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| William Carey University Physical Therapy Program | Hattiesburg | Mississippi | 39401 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03810963, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 3, 2019 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03810963 live on ClinicalTrials.gov.