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RECRUITING
NCT06290713
PHASE2

Vasodilator and Exercise Study for DMD (VASO-REx)

Sponsor: University of Florida

View on ClinicalTrials.gov

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

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.

Locations (1)

University of Florida Clinical and Translational Research Building

Gainesville, Florida, United States