ClinicalTrials.Veeva

Menu

Pilot Randomized Trial of Ambulatory Exercise in Pulmonary Hypertension (PaRTAkE-PH)

University of Michigan logo

University of Michigan

Status

Withdrawn

Conditions

Pulmonary Arterial Hypertension

Treatments

Behavioral: Home-based exercise program
Behavioral: Usual Care

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT04254289
HUM00150343

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No 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.
  • Pregnancy or lactation
  • Non-English speaking

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

0 participants in 2 patient groups

Usual Care
Active Comparator group
Description:
Usual care administered at the Pulmonary Arterial Hypertension (PAH) clinic at the University of Michigan.
Treatment:
Behavioral: Usual Care
Home-based exercise program
Experimental group
Description:
Home-based individualized exercise program based on heart rate reserve (HRR).
Treatment:
Behavioral: Home-based exercise program

Trial contacts and locations

1

Loading...

Central trial contact

Thomas Cascino, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems