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NCT02421523 · ClinicalTrials.gov registry record · NA
Strength Training in Duchenne Muscular Dystrophy
A NA study, sponsored by University of Florida.
- Completed
- Registry status
- NA
- Development phase
- 18
- Enrollment target
NCT02421523: Completed NA study, sponsored by University of Florida.
NCT02421523 is a NA study that has completed, run by University of Florida. The registered enrollment target is 18 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
NCT02421523, a NA study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- NA
- Development phase
- 18 participants
- Enrollment target
Study Summary
Duchenne muscular dystrophy (DMD) is a debilitating neuromuscular disease that causes muscle breakdown, weakness, and eventual death. Over the last 40 years parents have received little guidance on the potential of exercise as a therapeutic strategy to maintain muscle function. It is well known that high intensity exercise and eccentric contractions can result in muscle damage in dystrophic muscle, yet the absence of muscle loading will conversely result in muscle wasting. Recent research in rodent models and milder forms of muscular dystrophy supports earlier studies that resistance exercise may have beneficial effects for maintenance of muscle mass in dystrophic muscle. However, careful and systematic investigation into the safety and feasibility of resistance exercise is needed to consider its implementation in boys with DMD. The goal of this project is to assess the safety and feasibility of a home based mild to moderate-intensity strengthening exercise program in boys with Duchenne muscular dystrophy (DMD). Evidence from milder forms of muscular dystrophy and mouse models of DMD suggests that strengthening exercise may be beneficial for these children, but this area has not been adequately explored using human subjects. The results of this study should provide information to assist in the development of scientifically based recommendations concerning optimal exercise parameters for patients with DMD.
Primary Outcome
In order to examine the distribution of affected tissue (versus unaffected tissue) across the lower extremity muscles, multi-slice spin-echo images will be acquired from the lower leg and thigh muscles. A pixel-by-pixel T2 map will be created for each slice (minimal 8 slices) by fitting the decay in image signal intensity (SI) to a single exponential (SI=Aexp-TE/T2+B; A=proton density) with respect to echo time (TE). The total affected tissue volume (% of pixels with T2 \>2SD above control) will
Interventions
- PROCEDURE Aim 2 Exercise group
- PROCEDURE Aim 1 Exercise Dosing
- PROCEDURE Aim 2 Control group
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2015-05-30 |
| Est. Completion | 2018-10-08 |
| Phase | NA |
What the finished NCT02421523 record still lists
NCT02421523 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 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 3 interventions - of which Aim 2 Exercise group is the first listed.
NCT02421523 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02421523 about?
NCT02421523 is a clinical study titled "Strength Training in Duchenne Muscular Dystrophy". Duchenne muscular dystrophy (DMD) is a debilitating neuromuscular disease that causes muscle breakdown, weakness, and eventual death. Over the last 40 years parents have received little guidance on the potential of exercise as a therapeutic strategy to maintain muscle function. It is well known that...
What is the current status of trial NCT02421523?
This trial is currently completed. It is a NA study. The enrollment target is 18 participants. The study started on 2015-05-30. Estimated completion is 2018-10-08.
What interventions are being tested in trial NCT02421523?
The interventions under investigation include: Aim 2 Exercise group (PROCEDURE), Aim 1 Exercise Dosing (PROCEDURE), Aim 2 Control group (PROCEDURE).
Who is sponsoring clinical trial NCT02421523?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02421523's enrollment target sits among peer trials
18 1863rd of 2000 higher than 130 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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