Clinical Trial: Aerobic Exercise in Patients With Pulmonary Hypertension

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The NIH Exercise Therapy for Advanced Lung Disease Trials: Response and Adaptation to Aerobic Exercise in Patients With Pulmonary Hypertension: Initial Studies for Establi

Brief 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).

    • Detailed Summary:

    We propose a randomized trial to determine the safety and effectiveness of aerobic exercise for patients who have primary pulmonary hypertension (PH) or PH secondary to interstitial lung disease (ILD). This project will be the first in a series of studies aimed at establishing exercise prescription and general rehabilitation guidelines for patients who have advanced lung diseases.

    An essential treatment for almost all cardiovascular and pulmonary disorders is aerobic exercise training. The effectiveness of exercise rehabilitation has been established and exercise rehabilitation has become a standard of care for patients with chronic obstructive pulmonary disease (COPD). However, fundamental information about the mechanisms underlying exercise training and its therapeutic benefits remains lacking for patients who have advanced lung disease in general and specifically for those with PH.

    Subjects will be over the age of 21 years. The patients will be enrolled from sites within a reasonable travel distance from the greater Washington area and will receive their exercise training at Inova Fairfax Hospital or at the National Institutes of Health (NIH) main campus. Exercise-based rehabilitation is already common for patients who have PH at the Inova Fairfax Hospital. Their pulmonary rehabilitation program is well established, and their staff is experienced in providing exercise therapy for patients with PH and advanced lung diseases. The Rehabilitation Medicine Department (RMD) at The NIH Clinical Center has established a pulmonary rehabilitation program for this protocol as well as to provide rehabilitation services for NIH clinic patients.

    There will be two primary treatment arms. Patients with PH will be randomized to either aerobic exercise training plus education (AET) or edu
    Sponsor: National Institutes of Health Clinical Center (CC)

    Current Primary Outcome: Changes in the relationships among oxygen consumption, six-minute walk distance, and measures of health related quality of life.

    Original Primary Outcome: Same as current

    Current Secondary Outcome: Changes in the relationships among oxygen consumption, cardiac output and muscle oxygenation.

    Original Secondary Outcome: Same as current

    Information By: National Institutes of Health Clinical Center (CC)

    Dates:
    Date Received: May 14, 2008
    Date Started: May 6, 2008
    Date Completion:
    Last Updated: April 20, 2017
    Last Verified: September 2, 2016