Pilot Randomized Trial of Ambulatory Exercise in Pulmonary Hypertension

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04254289
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Michigan
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Thomas Cascino, MD
Principal Investigator Affiliation	University of Michigan
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Arterial Hypertension

Arms & Interventions

Arms

Active Comparator: Usual Care

Usual care administered at the Pulmonary Arterial Hypertension (PAH) clinic at the University of Michigan.

Experimental: Home-based exercise program

Home-based individualized exercise program based on heart rate reserve (HRR).

Interventions

Behavioral: - Usual Care

Usual care

Behavioral: - Home-based exercise program

Home-based program determined by exercise physiologist

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

The University of Michigan, Ann Arbor, Michigan

Status

Address

The University of Michigan

Ann Arbor, Michigan, 48109

Site Contact

Thomas Cascino

tcascino@umich.edu

734-232-0112