Pilot Randomized Trial of Ambulatory Exercise in Pulmonary Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-11

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulmonary Arterial Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

An independent statistician will develop the randomization schedule and an unblinded study team member will document and maintain the treatment assignment log. The investigators will be adjusting the exercise regimens of those randomized to the exercise program and are unable to be blinded. All patients will receive weekly telephone calls to review activity logs. Outcomes included in the primary and secondary analysis will be blinded as possible. The staff performing the 6-minute walk test (6MWT) and interpreting echocardiograms will be blinded to the group assignment.

Study Groups

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Usual Care

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

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type BEHAVIORAL

Usual care

Home-based exercise program

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

Group Type EXPERIMENTAL

Home-based exercise program

Intervention Type BEHAVIORAL

Home-based program determined by exercise physiologist

Interventions

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Usual Care

Usual care

Intervention Type BEHAVIORAL

Home-based exercise program

Home-based program determined by exercise physiologist

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No