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Pilot Randomized Trial of Ambulatory Exercise in Pulmonary Hypertension | Clinical Trials | Clareo Health

WITHDRAWNNA

Pilot Randomized Trial of Ambulatory Exercise in Pulmonary Hypertension

NCT04254289•University of Michigan

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+2 more criteria

Locations (1)

The University of Michigan

Ann Arbor, Michigan, United States

Key Dates

Start Date

August 11, 2024

Primary Completion Date

June 1, 2025

Completion Date

December 1, 2025

Last Updated

August 14, 2024

Conditions

Pulmonary Arterial Hypertension

Interventions

Usual Care

BEHAVIORAL

Home-based exercise program

BEHAVIORAL

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RECRUITINGPHASE1/PHASE2

A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

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RECRUITINGPHASE1

A Placebo-controlled, Randomized Clinical Trial to Assess the Safety, Feasibility, and Pharmacokinetics of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation in Patients With Pulmonary Arterial Hypertension

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 14, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pilot Randomized Trial of Ambulatory Exercise in Pulmonary Hypertension

Inclusion Criteria

Exclusion Criteria

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

A Placebo-controlled, Randomized Clinical Trial to Assess the Safety, Feasibility, and Pharmacokinetics of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation in Patients With Pulmonary Arterial Hypertension

COMPERA / COMPERA-KIDS

The MObile Health InterVEntion in Pulmonary Arterial Hypertension (MOVE PAH) Study

China Pulmonary Vascular Disease Intervention Diagnosis and Management Study-right Heart Catheterization