Aerobic Exercise in Patients With Pulmonary Hypertension

Summary

This study will determine if a rehabilitation exercise program can help people with pulmonary hypertension (PH) increase their physical activity. Patients with PH have an increase in blood pressure in the pulmonary blood vessels (artery, vein or capillaries) that leads to shortness of breath, dizziness, fainting and other symptoms.

Healthy volunteers and people with pulmonary hypertension between 21 and 75 years of age may be eligible for this study.

All participants undergo the following tests and procedures:

* Medical history and physical examination
* 6-minute walk test: Subjects walk as fast as they can for 6 minutes on a walking track to determine their ability to participate in physical activity.
* Questionnaires: Subjects complete nine questionnaires related to their fatigue, daily physical activity, mood, and so forth.
* Maximum treadmill test: The exercise begins at an easy level and gradually increases until the subject says he or she can no longer continue or the investigator decides it is not safe to continue. Subjects are fitted with a mask, electrodes and light sensors to measure how well the heart is working and how well the muscles use oxygen.

Patients with pulmonary hypertension undergo the following additional procedures:

* Activity monitoring: Patients wear a monitor for 3 days that measures movement and heart rate.
* Group assignment: Patients are randomly assigned to Group 1 (education plus aerobic exercise) or Group 2 (education followed by exercise).
* Group 1 patients will attend classes three days a week at either Inova Fairfax Hospital Pulmonary Rehabilitation Center or The National Institutes of Health for 10 weeks. Two sessions a week will include a 1 hour education session as well as a 30-45 minute track or treadmill exercise session. The third session will only include exercise. During the education patients will learn about a healthy lifestyle with pulmonary hypertension. After the 10 weeks of education and exercise, subjects repeat the 6-minute walk test, maximum treadmill test and questionnaires.
* Group 2 patients participate in 2; 1-hour educational session at either the Inova Pulmonary Rehabilitation Center or The National Institutes of Health for 10 weeks. After the classes, they repeat the 6-minute walk test, maximum treadmill test and questionnaires. The following 10 weeks will consist of 3 days a week of 30-45 minute track or treadmill walking at either Inova or NIH, after which they again repeat the questionnaires, treadmill and walk tests.

Conditions

• Pulmonary Hypertension
• Interstitial Lung Disease

Interventions

OTHER

Aerobic exercise

Supervised aerobic exercise and educational lectures for 10 weeks

Sponsors & Collaborators

• George Mason University

  collaborator OTHER

• Inova Fairfax Hospital

  collaborator OTHER

• National Institutes of Health Clinical Center (CC)

  lead NIH

Principal Investigators

• Leighton Chan, M.D. · National Institutes of Health Clinical Center (CC)

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

21 Years

Max Age

82 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-06-12

Primary Completion

2015-09-23

Completion

2015-09-23

Countries

• United States

Study Locations