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NCT07648173 · ClinicalTrials.gov registry record · NA
Hybrid HIIT-FES Cycling Program on Individuals With Spinal Cord Injury to Improve Health
A NA study, sponsored by William Carey University.
- Recruiting
- Registry status
- NA
- Development phase
- 12
- Enrollment target
NCT07648173: Recruiting NA study, sponsored by William Carey University.
NCT07648173 is a NA study that is actively recruiting participants, run by William Carey University. The registered enrollment target is 12 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07648173, a NA study, is actively recruiting participants, sponsored by William Carey University.
- RECRUITING
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
Study Summary
Project Summary/Abstract Obesity and metabolic syndrome (obesity, dyslipidemia, hyperglycemia, hypertension) are epidemic in the spinal cord injured (SCI) population. A recent study assessing the body composition and metabolic syndrome rates of 72 motor complete chronic SCI individuals revealed an obesity rate of over 90% and a metabolic syndrome rate of 60%. These results are significantly higher than in the general population. As such individuals with SCI typically have systemic inflammation and an accelerated trajectory towards cardiometabolic disease, and early mortality. Although the accelerated trajectory is multi-factorial, substantial evidence implicates sedentary behavior and low physical activity levels as significant contributing factors. Exercise strategies for individuals with SCI have included upper body arm crank exercise (ACE), functional electrical stimulation leg cycling exercise (FES-LCE), or a combination of the two (FES Hybrid Exercise). These modalities have yielded modest improvements in physical fitness and cardiometabolic risk profiles in individuals with SCI. FES-LCE reportedly increased lean-to-fat mass ratio, enhanced peripheral blood flow and vasoreactivity, and increased bone mass in the paralyzed legs. In addition, FES-LCE improves metabolic function as evidenced by increased glucose disposal. There is evidence that high-intensity interval training exercise can increase muscle mass and improve cardiovascular fitness with considerably less time commitment than non-interval activities. However, given many individuals with SCI respond poorly to the onset of training a primer exercise program for the extremely deconditioned muscles is recommended for optimal results. The investigators intend to investigate the optimization of benefits by using a novel hybrid FES cycling protocol (FES legs cycling plus voluntary arms cycling) combined with high intensity interval training (HIIT) and preceded by a preparatory muscle strengthening program cal
Primary Outcome
Vo2peak determined by arm crank maximal exercise stress test
Interventions
- OTHER Muscle strengthening exercise followed by Hybrid FES cycling Exercise
- OTHER Active ROM exercise with arms and Passive ROM exercise with legs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2026-03-03 |
| Est. Completion | 2027-08-31 |
| Phase | NA |
What NCT07648173 shows while recruiting
NCT07648173 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Muscle strengthening exercise followed by Hybrid FES cycling Exercise is the first listed.
NCT07648173 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07648173 about?
NCT07648173 is a clinical study titled "Hybrid HIIT-FES Cycling Program on Individuals With Spinal Cord Injury to Improve Health". Project Summary/Abstract Obesity and metabolic syndrome (obesity, dyslipidemia, hyperglycemia, hypertension) are epidemic in the spinal cord injured (SCI) population. A recent study assessing the body composition and metabolic syndrome rates of 72 motor complete chronic SCI individuals revealed an o...
What is the current status of trial NCT07648173?
This trial is currently recruiting. It is a NA study. The enrollment target is 12 participants. The study started on 2026-03-03. Estimated completion is 2027-08-31.
What interventions are being tested in trial NCT07648173?
The interventions under investigation include: Muscle strengthening exercise followed by Hybrid FES cycling Exercise (OTHER), Active ROM exercise with arms and Passive ROM exercise with legs (OTHER).
Who is sponsoring clinical trial NCT07648173?
This trial is sponsored by William Carey University, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07648173's enrollment target sits among peer trials
12 1913th of 2000 higher than 74 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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