Pilot Randomized Trial of Ambulatory Exercise in Pulmonary Hypertension
Megadott ok: Lack of enrollment
Key facts
- Where
- Ann Arbor, Egyesült ÁllamokSee the site
Where in Egyesült Államok
- The University of MichiganAnn Arbor, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- University of Michigan
- Trial code
- NCT04254289
- Record updated
- 2024. augusztus 14.
- Original description
The researchers are investigating if changing an individual's behaviors may have an impact on outcomes for patients with pulmonary arterial hypertension (PAH). This research will test the efficacy of a home-based exercise program to improve exercise tolerance and physical activity.Read full original descriptionShow less
The researchers are investigating if changing an individual's behaviors may have an impact on outcomes for patients with pulmonary arterial hypertension (PAH). This research will test the efficacy of a home-based exercise program to improve exercise tolerance and physical activity.
Inclusion: Diagnosis of group 1 Pulmonary Atrial Hypertension (PAH) diagnosed during right heart catheterization (RHC) according to WHO criteria 28; WHO functional class II to III; Stable clinical condition, with no change in medical therapy for pulmonary arterial hypertension (PAH) for at least 3 months before enrollment; Planned follow-up at University of Michigan Hospital Centers over at least 1 year; If enrolled in clinical trial, must be in open-label extension stage on stable medications for at least 3 months; Competent to give informed consent; Have computer and internet access.
Exclusion: ≥30 minutes of exercise, ≥ 1 day per week for the previous 3 months; Co-morbidities which limit physical activity to a severe degree (i.e., permanently wheelchair bound, musculoskeletal disorders, recent myocardial infarction, unstable arrhythmia); Current substance abuse, and/or a severe psychiatric disorder (including severe depression, psychosis, or dementia) which limits the patient's ability to follow the study protocol; Moderate or severe obstructive lung disease forced expiratory volume/forced vital capacity (FEV1/FVC) < 70% and FEV1 < 65% of predicted value after bronchodilator administration); Moderate or severe restrictive lung disease (total lung capacity < 60% predicted value); History of exercise-induced syncope or arrhythmias; Life expectancy under 1 year; Recently completed (<6 months), current enrollment or planned enrollment in pulmonary rehab; Six-minute walk distance <150 meters or >550 meters; Arterial oxygen saturation (SpO2) <88% during 6-minute walk test on baseline home oxygen prescription if applicable or SpO2 <80% if uncorrected shunt; Pregnancy or lactation; Non-English speaking.