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NCT02660073 · ClinicalTrials.gov registry record · NA
Skeletal Muscle Hypertrophy and Cardio-Metabolic Benefits After Spinal Cord Injury
A NA study, sponsored by United States Department of Defense.
- Completed
- Registry status
- NA
- Development phase
- 48
- Enrollment target
NCT02660073 is a NA study that has completed, run by United States Department of Defense. The registered enrollment target is 48 participants.
The verdict
NCT02660073, a NA study, has completed, sponsored by United States Department of Defense.
- COMPLETED
- Registry status
- NA
- Development phase
- 48 participants
- Enrollment target
Study Summary
Spinal cord injury (SCI) is a devastating medical problem that affects thousands of civilian and military personnel in the United States. Spinal cord injuries (SCI) predispose individuals to impaired fitness, obesity, glucose intolerance and insulin resistance, placing them at greater risk for diabetes and coronary artery disease. These are devastating problems that occur frequently because of changes in body composition and reduced level of physical activity. Skeletal muscle wasting plays a central role in altered metabolism after SCI. Functional electrical stimulation (FES) is an effective rehabilitation tool that has been used to train the paralyzed skeletal muscles and which has shown some ability to ameliorate the deleterious effects of SCI on metabolism, particularly on insulin sensitivity. However, its ability to reverse skeletal muscle wasting is modest; most studies report limited gains in muscle mass and workload with highly variables outcomes from one study to another. This proposal was stimulated by the findings that a program of neuromuscular electrical stimulation resistance exercise prior to initiating functional electrical stimulation lower extremity cycling (FES-LEC) improves the gains in muscle mass and workload observed with FES. The specific objectives for the current proposal are to compare the impact of FES following evoking skeletal muscle hypertrophy of the lower extremity versus initiating FES cycling without introducing the hypertrophy effects on insulin sensitivity, control of blood sugar levels, oxygen uptake and amounts of muscle tissue and fat deposition. These studies could potentially have significant effects on thousands of people that will experience an SCI in the future as well as those living with SCI where prolonged paralysis is a major quality of life issue. There is a major need to investigate the mechanisms lead to maximize the benefits of FES applications and to understand cellular or molecular events that are associated wit
Interventions
- DEVICE NMES+FES
- DEVICE Control+FES
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2015-10 |
| Est. Completion | 2020-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02660073
The ClinicalTrials.gov registry entry for NCT02660073 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is United States Department of Defense, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which NMES+FES is the first listed.
NCT02660073 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02660073 about?
NCT02660073 is a clinical study titled "Skeletal Muscle Hypertrophy and Cardio-Metabolic Benefits After Spinal Cord Injury". Spinal cord injury (SCI) is a devastating medical problem that affects thousands of civilian and military personnel in the United States. Spinal cord injuries (SCI) predispose individuals to impaired fitness, obesity, glucose intolerance and insulin resistance, placing them at greater risk for diabe...
What is the current status of trial NCT02660073?
This trial is currently completed. It is a NA study. The enrollment target is 48 participants. The study started on 2015-10. Estimated completion is 2020-09.
What interventions are being tested in trial NCT02660073?
The interventions under investigation include: NMES+FES (DEVICE), Control+FES (DEVICE).
Who is sponsoring clinical trial NCT02660073?
This trial is sponsored by United States Department of Defense, which has 13 total clinical trials registered on ClinicalTrials.gov.
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