Vasodilator and Exercise Study for DMD (VASO-REx)

PHASE2RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

June 5, 2024

Primary Completion Date

November 30, 2026

Study Completion Date

November 30, 2026

Conditions
Duchenne Muscular DystrophyDuchenne DiseaseMuscular DystrophyMuscular Dystrophy in ChildrenVasodilationExerciseDMD
Interventions
DRUG

Tadalafil

Patients will be given either the intervention medication or a placebo (double-blinded, randomized trial) and will be asked to take the medication every day for 6 months in conjunction with weekly exercise sessions.

DRUG

Placebo

Patients will be given either the intervention medication or a placebo (double-blinded, randomized trial) and will be asked to take the medication every day for 6 months in conjunction with weekly exercise sessions.

OTHER

Exercise Training

The home-based cycling exercise training program is designed to improve muscle strength and endurance. Participants will engage in individualized exercise sessions up to four times per week, lasting up to 40 minutes each. Live video and heart rate monitoring will ensure proper exercise performance and allow for adjustments to the program throughout the study. The participants will receive the exercise equipment for use at home.

Trial Locations (1)

32603

RECRUITING

University of Florida Clinical and Translational Research Building, Gainesville

All Listed Sponsors
collaborator

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

NIH

lead

University of Florida

OTHER