Aerobic Exercise in Patients With Pulmonary Hypertension
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.
Procedure: Excerise Training
Procedure: Patient Education (Placebo)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
|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 Establishing Guidelines|
- Changes in the relationships among oxygen consumption, six-minute walk distance, and measures of health related quality of life.
- Changes in the relationships among oxygen consumption, cardiac output and muscle oxygenation.
|Study Start Date:||May 2008|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Procedure: Excerise Training
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 education only (Ed-only) treatments. A comparison group of patients with ILD who do not have secondary PH (ILD-only) will also undergo the AET arm. Exercise training will consist of a 10-week regimen of supervised treadmill or over ground walking three times a week. Exercise session duration will be 30 minutes and will progress to 45 minutes per session over the 10 weeks. The intensity of the exercise will be between 70 and 80% of the heart rate reserve.
There will also be two secondary studies. First, the subjects with PH initially randomized to the education only arm will complete an aerobic exercise training program after participation in education. In addition, we will also compare baseline tests among patients with PH, patients with ILD-only and healthy controls.
The study outcome measures will be assessed at NIH, RMD. These will include pre- and post-exercise training comparisons of symptom limited treadmill exercise tests to assess heart rate, pulse oximetry, EKG, maximum oxygen consumption, bioelectrical impedance cardiography, and near infrared spectroscopy measurements of muscle oxygenation. We will also assess accelerometry based activity, 6-minute walk distance, and a number of other quality of life and functional measures questionnaires including: International Physical Activity Questionnaire, Fatigue Severity Scale, SF-36v2 Health Survey, Human Activity Profile, Stages of Exercise Change, Exercise Self-Efficacy, Profile of Mood States, Cambridge Pulmonary Hypertension Outcome Review.
This study represents a unique opportunity to assess the effects of exercise on patients with advanced lung disease and may open up valuable new treatment options for these patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00678821
|Contact: Anne B Quinn, R.N.||(301) firstname.lastname@example.org|
|Contact: Leighton Chan, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Leighton Chan, M.D.||National Institutes of Health Clinical Center (CC)|