RecruitingPhase 2NCT06290713

Vasodilator and Exercise Study for DMD (VASO-REx)

Vasodilators and Exercise as Adjuvant Therapy for Duchenne Muscular Dystrophy (VASO-REx Study)

Sponsor

University of Florida

Enrollment

50 participants

Start Date

Jun 5, 2024

Study Type

INTERVENTIONAL

Conditions

Exercise Duchenne Muscular Dystrophy DMD Muscular Dystrophy Vasodilation Duchenne Disease Muscular Dystrophy in Children

Summary

Examining two strategies as potential adjuvant therapies for Duchenne muscular dystrophy (DMD); aerobic exercise training (to induce adaptations in skeletal muscle and improve cardiovascular health) and tadalafil, an FDA-approved vasodilator (to optimize blood flow and muscle perfusion which is impaired and often overlooked in DMD). Target: improved muscle function, vascular health, and DMD treatment.

Eligibility

Sex: MALEMin Age: 6 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Exercise Training, a drug called Placebo, and others for people with dmd, duchenne disease, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include men aged 6 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTadalafil

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.

DRUGPlacebo

OTHERExercise 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.