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NCT03810963 · ClinicalTrials.gov registry record · NA
FES Cycling and Nutritional Counseling for Battling Obesity After SCI
A NA study of Spinal Cord Injuries, sponsored by William Carey University.
- Completed
- Registry status
- NA
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT03810963: Completed NA study of Spinal Cord Injuries, sponsored by William Carey University.
NCT03810963 is a NA study of Spinal Cord Injuries that has completed, run by William Carey University. The registered enrollment target is 15 participants, below the 62-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03810963, a NA study of Spinal Cord Injuries, has completed, sponsored by William Carey University.
- COMPLETED
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
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)
Primary Outcome
Percentage of body fat measured during pre- and post-testing
Conditions Studied
Interventions
- COMBINATION_PRODUCT HIIT-FES Cycling combined with Nutritional Counseling
- OTHER Nutritional Counseling Only
Study Locations (1)
Mississippi
- William Carey University Physical Therapy Program - Hattiesburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2017-05-01 |
| Est. Completion | 2019-05-01 |
| Phase | NA |
What the finished NCT03810963 record still lists
NCT03810963 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 62-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (76% lower).
The record links to 1 condition, with Spinal Cord Injuries appearing as the primary indexed condition, and to 2 interventions - of which HIIT-FES Cycling combined with Nutritional Counseling is the first listed.
NCT03810963 reports a single indexed study location in Mississippi.
Frequently Asked Questions
What is clinical trial NCT03810963 about?
NCT03810963 is a clinical study titled "FES Cycling and Nutritional Counseling for Battling Obesity After SCI". 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 melli...
What is the current status of trial NCT03810963?
This trial is currently completed. It is a NA study. The enrollment target is 15 participants. The study started on 2017-05-01. Estimated completion is 2019-05-01.
What conditions does trial NCT03810963 study?
This clinical trial studies the following conditions: Spinal Cord Injuries.
What interventions are being tested in trial NCT03810963?
The interventions under investigation include: HIIT-FES Cycling combined with Nutritional Counseling (COMBINATION_PRODUCT), Nutritional Counseling Only (OTHER).
Who is sponsoring clinical trial NCT03810963?
This trial is sponsored by William Carey University, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03810963 being conducted?
This trial has 1 study location across Mississippi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03810963's enrollment target sits among peer trials
15 151st of 202 higher than 45 of 202 other Spinal Cord Injuries trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Spinal Cord Injuries trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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