NCT02421523

Strength Training in Duchenne Muscular Dystrophy

Completed NA Last updated 6 March 2019

What this trial tests

NA trial testing Aim 2 Exercise group in Duchenne Muscular Dystrophy in 18 participants. Completed in 8 October 2018.

Timeline

30 May 2015

Primary endpoint
15 February 2018

8 October 2018

Quick facts

Lead sponsor	University of Florida
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	18
Start date	30 May 2015
Primary completion	15 February 2018
Estimated completion	8 October 2018
Sites	1 location across United States

Drugs / interventions tested

• Aim 2 Exercise group
• Aim 1 Exercise Dosing
• Aim 2 Control group

Conditions studied

• Duchenne Muscular Dystrophy — all drugs for Duchenne Muscular Dystrophy →

Sponsor

University of Florida

Who can join

Adults 7 to 10, male only, with Duchenne Muscular Dystrophy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Strength training and aerobic exercise training for muscle disease.
   Voet NB, van der Kooi EL, van Engelen BG, Geurts AC. · · 2019 · cited 65× · PMID 31808555 · DOI 10.1002/14651858.cd003907.pub5
2. Progress and prospects of gene therapy clinical trials for the muscular dystrophies.
   Bengtsson NE, Seto JT, Hall JK, Chamberlain JS, et al · · 2016 · cited 48× · PMID 26450518 · DOI 10.1093/hmg/ddv420
3. Isometric resistance training increases strength and alters histopathology of dystrophin-deficient mouse skeletal muscle.
   Lindsay A, Larson AA, Verma M, Ervasti JM, et al · · 2019 · cited 28× · PMID 30571283 · DOI 10.1152/japplphysiol.00948.2018
4. Effect of Muscular Exercise on Patients With Muscular Dystrophy: A Systematic Review and Meta-Analysis of the Literature.
   Gianola S, Castellini G, Pecoraro V, Monticone M, et al · · 2020 · cited 15× · PMID 33281695 · DOI 10.3389/fneur.2020.00958