Pilot Randomized Trial of Ambulatory Exercise in Pulmonary Hypertension

University of Michigan1 site in 1 countryAugust 11, 2024

ConditionsPulmonary Arterial Hypertension

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pulmonary Arterial Hypertension
Sponsor: University of Michigan
Locations: 1
Primary Endpoint: Efficacy of a home-based exercise training as measured by change in six-minute walk distance
Status: Withdrawn
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 11, 2024

End Date

December 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Michigan

Responsible Party

Principal Investigator

Thomas Matthew Cascino

Clinical Lecturer in Internal Medicine

University of Michigan

Eligibility 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.

Outcomes

Primary Outcomes

Efficacy of a home-based exercise training as measured by change in six-minute walk distance

Time Frame: Baseline, 12 weeks

Distance measured in meters

Secondary Outcomes

Efficacy of a home-based exercise training as measured by change in treadmill exercise time(Baseline, 12 weeks)
Efficacy of a home-based exercise training as measured by change in survey score Patient Health Questionnaire (PHQ)-8(Baseline, 6 months)
Efficacy of a home-based exercise training as measured by change in survey score International Physical Activity Questionnaire Short Form (IPAQ-SF)(Baseline, 6 months)
Efficacy of a home-based exercise training as measured by change in World Health Organization (WHO) functional class(Baseline, 6 months)
Efficacy of a home-based exercise training as measured by change in six-minute walk distance(Baseline, 6 months)
Efficacy of a home-based exercise training as measured by change in survey score from the EuroQol five dimension, five level (EQ-5D-5L) questionnaire.(Baseline, 6 months)
Efficacy of a home-based exercise training as measured by change in survey score The Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT)(Baseline, 6 months)
Change in physical activity as measured by daily activity captured using the pedometer step count(Baseline, 6 months)