protocolSection identificationModule nctId: NCT06290713, orgStudyIdInfo id: IRB202301491, secondaryIdInfos id: 1R21AR079755-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1R21AR079755-01, secondaryIdInfos id: PRO00050023, type: OTHER, domain: UFIRST, briefTitle: Vasodilator and Exercise Study for DMD (VASO-REx), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-11, completionDateStruct date: 2026-11, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: University of Florida, class: OTHER, collaborators name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), descriptionModule briefSummary: 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., conditionsModule conditions: Duchenne Muscular Dystrophy, conditions: Duchenne Disease, conditions: Muscular Dystrophy, conditions: Muscular Dystrophy in Children, conditions: Vasodilation, conditions: Exercise, conditions: DMD, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants are assigned to receive interventions based on their completion and results of Aim 1 (responsiveness to study drug). If participants are found to be Tadalafil-responsive after one dose, they will be included in Aim 2 of the study and will be asked to participate in the double-blinded, randomized, placebo-controlled longitudinal medication \& exercise 6-month study program., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Tadalafil, interventions name: Placebo, interventions name: Exercise Training, outcomesModule primaryOutcomes measure: Vascular responsiveness after muscle contraction to a single dose of tadalafil., primaryOutcomes measure: Cycling time to fatigue, secondaryOutcomes measure: Quadriceps muscle Fat Fraction, secondaryOutcomes measure: Metabolic recovery, secondaryOutcomes measure: cardiopulmonary exercise testing (CPET) - Peak aerobic capacity (VO2max), secondaryOutcomes measure: cardiopulmonary exercise testing (CPET) - Minute Ventilation (VE), secondaryOutcomes measure: cardiopulmonary exercise testing (CPET) - Ventilatory Equivalent for Oxygen (VE/VO2), secondaryOutcomes measure: cardiopulmonary exercise testing (CPET) - Gas Exchange Threshold (GET), secondaryOutcomes measure: cardiopulmonary exercise testing (CPET) - Workload at Anaerobic Threshold (W at AT), secondaryOutcomes measure: The 100-meter timed test (100m), secondaryOutcomes measure: the North Star Ambulatory Assessment (NSAA), secondaryOutcomes measure: The 4-stair climb, secondaryOutcomes measure: The Physical activity questionnaire (PAQ-C), secondaryOutcomes measure: Pulmonary function testing - vital capacity (FVC), secondaryOutcomes measure: Pulmonary function testing - forced expiratory volume in 1 second (FEV1), secondaryOutcomes measure: Neurology Quality of Life (NeuroQoL) pediatric lower extremity function, secondaryOutcomes measure: Patient Reported Outcomes Measurement Information System (PROMIS) pediatric fatigue, secondaryOutcomes measure: PROMIS parent proxy for physical activity, secondaryOutcomes measure: PROMIS pediatric physical activity, secondaryOutcomes measure: Physical Activity Monitoring - Daily Step Rate, secondaryOutcomes measure: Physical Activity Monitoring - Time in Low-Level Activity, secondaryOutcomes measure: Physical Activity Monitoring - Time in Moderate-Level Activity, secondaryOutcomes measure: Physical Activity Monitoring - Time in High-Level Activity, eligibilityModule sex: MALE, minimumAge: 6 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False