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Vasodilator and Exercise Study for DMD (VASO-REx)
Sponsor: University of Florida
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.
Official title: Vasodilators and Exercise as Adjuvant Therapy for Duchenne Muscular Dystrophy (VASO-REx Study)
Key Details
Gender
MALE
Age Range
6 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2024-06-05
Completion Date
2026-11
Last Updated
2025-07-09
Healthy Volunteers
No
Conditions
Interventions
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.
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.
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.
Locations (1)
University of Florida Clinical and Translational Research Building
Gainesville, Florida, United States