NOT_YET_RECRUITING
Pilot Randomized Trial of Ambulatory Exercise in Pulmonary Hypertension
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.
Conditions:
🦠 Pulmonary Arterial Hypertension
🗓️ Study Start (Actual) June 2024
🗓️ Primary Completion (Estimated) June 2025
✅ Study Completion (Estimated) December 2025
👥 Enrollment (Estimated) 54
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Ann Arbor, Michigan, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 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 Criteria:

    • * 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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 2 February 2020
  • First Submitted that Met QC Criteria 2 February 2020
  • First Posted 5 February 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 15 May 2024
  • Last Update Posted 16 May 2024
  • Last Verified May 2024