Strength Training in Duchenne Muscular Dystrophy

NACompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

May 30, 2015

Primary Completion Date

February 15, 2018

Study Completion Date

October 8, 2018

Conditions
Duchenne Muscular Dystrophy
Interventions
PROCEDURE

Aim 2 Exercise group

The experimental group will participate in an isometric exercise strengthening intervention with a frequency of \~three times/week for 12 weeks. Training will include using a custom-built exercise set-up and a live monitoring system for all of the subjects who participate in the experimental group. Progression of the exercise program will only occur after safety assessments at weeks 3, 6, and 9. The safety assessments to occur at baseline, 1 week, 6 weeks, and 12 weeks include T2 MRI, Spectroscopic relaxometry, pain rating scale, and CK levels. The safety assessments to occur at 3 weeks and 9 weeks include the pain rating scale and CK levels. Participants in this group may also be tested for strength assessments (of the knee flexors and extensors) and time to climb 4 stairs.

PROCEDURE

Aim 1 Exercise Dosing

The maximal voluntary contraction (MVC) will be determined for each subject. The first four subjects will exercise at an intensity of \~30% of the subject's MVC. Subjects will be asked to perform \~4 sets of 6 reps of knee extension and knee flexion contractions. 48hs after the exercise is completed a safety assessment will be performed for muscle damage. If none has occurred, four additional subjects will perform the exercise at the next level of intensity (\~50% MVC). Similarly, if no damage has occurred at \~50% MVC, four more subjects exercise at \~70% MVC. All safety measures will be performed 48hrs after the exercise has been completed at each of the levels. These safety assessments include T2 MRI, Spectroscopic relaxometry, pain rating scale, and CK levels.

PROCEDURE

Aim 2 Control group

This group will receive safety assessments at baseline, 1 week, 6 weeks, and 12 weeks including T2 MRI, Spectroscopic relaxometry, pain rating scale, and CK levels. They will also receive safety assessments at 3 weeks and 9 weeks that will include the pain rating scale and CK levels. Participants in this group may also be tested for strength assessments (of the knee flexors and extensors) and time to climb 4 stairs.

Trial Locations (1)

32611

University of Florida, Gainesville

All Listed Sponsors
collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

lead

University of Florida

OTHER

NCT02421523 - Strength Training in Duchenne Muscular Dystrophy | Biotech Hunter | Biotech Hunter