Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01244594 · ClinicalTrials.gov registry record · Phase 2
The Effects of Two Functional Electrical Stimulation Cycling Paradigms
A Phase 2 study, sponsored by Thomas Jefferson University.
- Completed
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT01244594 is a Phase 2 study that has completed, run by Thomas Jefferson University. The registered enrollment target is 17 participants.
The verdict
NCT01244594, a Phase 2 study, has completed, sponsored by Thomas Jefferson University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study Summary
Background: People with spinal cord injury (SCI) are at risk for many health conditions, some of which can be decreased with exercise. Cycling with Functional Electrical Stimulation (FES) is one way to obtain exercise after SCI. However, cycling with FES has only been done one way, which involves pedaling more quickly with less force to work against. Pedaling more slowly would allow the person to work against more force, which may lead to greater improvements in bone mineral density and muscle size. It may also lead to greater changes in bone make-up, body fat, and cholesterol levels. All of these improvements may lead to a decrease in bone fractures and cardiovascular disease, two major medical issues that exist in the SCI population. Study Aims: This study will compare the outcomes on bone, muscle and cardiovascular health between the commonly used method of pedaling more quickly to a new method of pedaling more slowly. Both groups will work against the maximal force possible. It is expected that the group pedaling more slowly will work against greater force and thus will have improved outcomes compared to other group pedaling faster. Methods: Twenty people with SCI, ages 18-65 years, will be randomly assigned to a treatment group and will participate in three 60-minute sessions per week for 6 months at an outpatient rehabilitation center. All subjects must have complete paralysis of both legs, but may have sensation preserved. Before and after 6 months of exercise, subjects will have an MRI scan to assess muscle size and bone, a dexascan to assess bone, a strength test using electrical stimulation to assess muscle force, an analysis of fat free body tissue, and lab work to measure cholesterol, bone factors that provide insight into bone change, and nutritional status. Relevance: If the protocol of pedaling more slowly results in greater improvements, this technique can be applied to clinical practice. Some people with SCI have FES cycles in their homes and many
Interventions
- OTHER Cycling with functional electrical stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2010-07 |
| Est. Completion | 2013-10 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01244594
The ClinicalTrials.gov registry entry for NCT01244594 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Thomas Jefferson University, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cycling with functional electrical stimulation is the first listed.
NCT01244594 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01244594 about?
NCT01244594 is a clinical study titled "The Effects of Two Functional Electrical Stimulation Cycling Paradigms". Background: People with spinal cord injury (SCI) are at risk for many health conditions, some of which can be decreased with exercise. Cycling with Functional Electrical Stimulation (FES) is one way to obtain exercise after SCI. However, cycling with FES has only been done one way, which involves p...
What is the current status of trial NCT01244594?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2010-07. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01244594?
The interventions under investigation include: Cycling with functional electrical stimulation (OTHER).
Who is sponsoring clinical trial NCT01244594?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.