Trial · NCT06290713
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Vascular responsiveness after muscle contraction to a single dose of tadalafil. | up to 4 weeks after the completion of Visits 1 and 2 of Aim 1. | Responsiveness will be determined by an increase in post-contractile muscle oxygenation using MRI-Blood Oxygen Level Dependent (BOLD) responses after dosing compared to before. Study participants demonstrating an increase (\>50%) in post-contractile BOLD after tadalafil will be enrolled into Aim 2 of this study. |
| Primary | Cycling time to fatigue | Baseline and 6 month follow-up visits of Aim 2. | The study will assess the impact of tadalafil on exercise performance and fatigue resistance compared to placebo. Participants will undergo a maximal effort cycling test before and after the intervention period. The time it takes for participants to reach exhaustion (TTE) will be recorded as the primary outcome measure. Measurement: Time to exhaustion (TTE) during a maximal effort cycling test on a recumbent, stationary ergometer. This test will quantify fatigue resistance by measuring the duration participants can sustain maximal effort cycling. |
| Secondary | Quadriceps muscle Fat Fraction | Aim 1 and Aim 2 (baseline and 6 month follow-up) | This outcome serves as a measure of disease severity. This measure is a sensitive and reproducible biomarker of DMD muscle pathology. |
| Secondary | Metabolic recovery | Through study completion, an average of 3 years. | The rate of phosphocreatine resynthesis after leg exercise will be quantified and serves as index of skeletal muscle mitochondrial oxidative capacity. (Part of Aim 2 of the study). |
| Secondary | cardiopulmonary exercise testing (CPET) - Peak aerobic capacity (VO2max) | Through study completion, an average of 3 years. | Patients will undergo cycling exercise at submaximal and peak workloads to quantify peak aerobic capacity, ventilation. Peak Oxygen Uptake (VO2max): This measure quantifies the maximum amount of oxygen the body can utilize during exercise, assessed through maximal cycling effort in a CPET. It serves as a primary indicator of overall cardiovascular and aerobic fitness. Peak aerobic capacity: VO2max reflects the maximum oxygen utilization capacity, indicating overall cardiovascular fitness. |
| Secondary | cardiopulmonary exercise testing (CPET) - Minute Ventilation (VE) | Through study completion, an average of 3 years. | Minute Ventilation (VE): This measure reflects the total volume of air breathed per minute during exercise, assessed throughout the CPET. Evaluating VE at various workloads provides insights into respiratory efficiency and potential limitations during exercise. Respiratory efficiency: VE and VE/VO2 assess how well the body utilizes oxygen during exercise, revealing potential respiratory limitations. |
| Secondary | cardiopulmonary exercise testing (CPET) - Ventilatory Equivalent for Oxygen (VE/VO2) | Through study completion, an average of 3 years. | Ventilatory Equivalent for Oxygen (VE/VO2): This ratio compares ventilation to oxygen uptake, calculated throughout the CPET. It indicates the efficiency of oxygen utilization during exercise and potential respiratory limitations. Respiratory efficiency: VE and VE/VO2 assess how well the body utilizes oxygen during exercise, revealing potential respiratory limitations. |
| Secondary | cardiopulmonary exercise testing (CPET) - Gas Exchange Threshold (GET) | Through study completion, an average of 3 years. | Gas Exchange Threshold (GET): This point during exercise marks the transition from predominantly aerobic to anaerobic metabolism, identified through changes in blood lactate levels and other CPET parameters. Analyzing GET helps assess exercise tolerance and potential for improvement. Exercise tolerance and fatigue: GET and W at AT pinpoint the intensity at which fatigue and performance decline become significant, offering insights into exercise limitations and potential for improvement. |
| Secondary | cardiopulmonary exercise testing (CPET) - Workload at Anaerobic Threshold (W at AT) | Through study completion, an average of 3 years. | Workload at Anaerobic Threshold (W at AT): This measure, derived from the CPET, quantifies the power output at which anaerobic metabolism significantly contributes to energy production. It reflects exercise intensity at which fatigue and performance decline become prominent. Exercise tolerance and fatigue: GET and W at AT pinpoint the intensity at which fatigue and performance decline become significant, offering insights into exercise limitations and potential for improvement. |
| Secondary | The 100-meter timed test (100m) | Through study completion, an average of 3 years. | The 100m is a fixed distance test of maximal performance and will be completed according to published guidelines. |
| Secondary | the North Star Ambulatory Assessment (NSAA) | Through study completion, an average of 3 years. | The North Star Ambulatory Assessment (NSAA) is a 17-item rating scale that is used to measure physical function and motor abilities in ambulatory boys with DMD and is increasingly being used in clinical trials as an overall measure of physical function. |
| Secondary | The 4-stair climb | Through study completion, an average of 3 years. | The time to ascend 4-stairs is a strength-measure. The patient is instructed to climb four standard steps (six inches in height each) with two handrails as fast as safely possible, using the rails if needed. |
| Secondary | The Physical activity questionnaire (PAQ-C) | Through study completion, an average of 3 years. | The PAQ-C is a self-administered, 7-day recall instrument developed to assess general levels of physical activity throughout the elementary school year for students in grades 4 to 8 and approximately 8 to 14 years, with high validity. Although reliability is considered to be moderate, other physical activity questionnaires are less reliable. Results will be correlated with indices of disease severity and tadalafil responsiveness. |
| Secondary | Pulmonary function testing - vital capacity (FVC) | Through study completion, an average of 3 years. | Measurement: FVC, measured using a standard spirometer according to American Thoracic Society guidelines. This is the maximum amount of air an individual can forcefully exhale after a full inhalation. Significance: FVC reflects the total lung capacity and is a key indicator of overall lung volume and function. It can help identify restrictive lung diseases, where lung volume is limited, and track respiratory health changes over time. |
| Secondary | Pulmonary function testing - forced expiratory volume in 1 second (FEV1) | Through study completion, an average of 3 years. | Measurement: FEV1, measured using a standard spirometer according to American Thoracic Society guidelines. This is the amount of air forcefully exhaled in the first second of a maximal exhalation after a full inhalation. Significance: FEV1 reflects the efficiency of airflow from the lungs and is sensitive to obstructive lung diseases, like asthma and Chronic Obstructive Pulmonary Disease (COPD), where airflow is impaired. |
| Secondary | Neurology Quality of Life (NeuroQoL) pediatric lower extremity function | Through study completion, an average of 3 years. | Questionnaire used to measure patient-reported outcomes of intervention impact. |
| Secondary | Patient Reported Outcomes Measurement Information System (PROMIS) pediatric fatigue | Through study completion, an average of 3 years. | Questionnaire used to measure patient-reported outcomes of intervention impact. |
| Secondary | PROMIS parent proxy for physical activity | Through study completion, an average of 3 years. | Questionnaire used to measure patient's parent-reported outcomes of intervention impact. |
| Secondary | PROMIS pediatric physical activity | Through study completion, an average of 3 years. | Questionnaire used to measure patient's parent-reported outcomes of intervention impact. |
| Secondary | Physical Activity Monitoring - Daily Step Rate | Through study completion, an average of 3 years. | Measurement: Total number of steps taken per day, assessed using the Actigraph activity monitor. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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