Pilot Randomized Trial of Ambulatory Exercise in Pulmonary Hypertension

Withdrawn before enrolling · Not applicable

Conditions studied: Pulmonary Arterial Hypertension

In brief

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.

Key facts

Study ID

NCT04254289

Run by

University of Michigan

People needed

0

Starts

2024-08-11

Expected to finish

2025-12-01

Last updated by the study team

2024-08-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Life expectancy under 1 year
• 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
• Recently completed (<6 months), current enrollment or planned enrollment in pulmonary rehab.
• ≥30 minutes of exercise, ≥ 1 day per week for the previous 3 months
• Six-minute walk distance <150 meters or >550 meters
• 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).
• Arterial oxygen saturation (SpO2) <88% during 6-minute walk test on baseline home oxygen prescription if applicable or SpO2 <80% if uncorrected shunt.
• History of exercise-induced syncope or arrhythmias.
• Pregnancy or lactation
• Non-English speaking

Where it is running

• The University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.