Pilot Randomized Trial of Ambulatory Exercise in Pulmonary Hypertension

NCT04254289 | Withdrawn

• 1 other identifier: HUM00150343
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Arterial Hypertension

Keywords

Exercise; Six-minute walk; Heart rate monitor

Outcome Measures

Primary Outcomes (1)

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

  Distance measured in meters

  Baseline, 12 weeks

Secondary Outcomes (14)

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

  Baseline, 6 months

• Change in physical activity as measured by daily activity captured using the pedometer step count

  Baseline, 12 weeks

• Change in physical activity as measured by daily activity captured using the pedometer step count

  Baseline, 6 months

• 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 from the EuroQol five dimension, five level (EQ-5D-5L) questionnaire.

  Baseline, 12 weeks

Other Outcomes (18)

• Change in heart rate recovery

  Baseline, 12 weeks

• Change in echocardiographic assessment of right ventricle size

  Baseline, 12 weeks

• Change in echocardiographic assessment of right ventricle function

  Baseline, 12 weeks

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

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

Behavioral: Usual Care

Home-based exercise program

EXPERIMENTAL

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

Behavioral: Home-based exercise program

Interventions

Usual Care BEHAVIORAL

Usual care

Usual Care

Home-based exercise program BEHAVIORAL

Home-based program determined by exercise physiologist

Home-based exercise program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Actelion: collaborator

Study Sites (1)

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Motor Activity

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Behavior

Study Officials

• Thomas Cascino, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Lecturer in Internal Medicine

Study Record Dates

• First Submitted: February 2, 2020
• First Posted: February 5, 2020
• Study Start: August 11, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 14, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)