Aerobic Exercise in Patients With Pulmonary Hypertension - Full Text View

Sponsored by:	National Institutes of Health Clinical Center (CC)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00678821

Purpose

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.
6-minute treadmill test: Subjects are fitted with a mask, electrodes and light sensors while walking on a treadmill at the speed they walked during the 6-minute walk test. This procedure allows measurement of how much oxygen the body is using and how well the muscles use oxygen.
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 participate in a 1-hour educational class at the INOVA Fairfax Hospital Pulmonary Rehabilitation Center three times a week for 10 weeks to learn about a healthy lifestyle with pulmonary hypertension. At each visit, subjects walk vigorously for 30-45 minutes on a track or treadmill. After the 10 weeks of education and exercise, subjects repeat the 6-minute walk test, 6-minute treadmill test, maximum treadmill test and questionnaires.
Group 2 patients participate in a 1-hour educational class at the INOVA Pulmonary Rehabilitation Center three times a week for 10 weeks. After the classes, they repeat the 6-minute walk test, 6-minute treadmill test, maximum treadmill test and questionnaires. Then they come to INOVA to exercise for 1 hour 3 days a week for 10 weeks, after which they again repeat the questionnaires, treadmill and walk tests.

Condition	Intervention	Phase
Hypertension, Pulmonary	Procedure: Excerise Training Procedure: Patient Education (Placebo)	Phase II

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: Exercise and Physical Fitness High Blood Pressure Pulmonary Hypertension Rehabilitation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Response and Adaptation to Aerobic Exercise in Patients With Pulmonary Hypertension: Initial Studies for Establishing Guidelines

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:

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

Secondary Outcome Measures:

Changes in the relationships among oxygen consumption, cardiac output and muscle oxygenation.

Estimated Enrollment:	135
Study Start Date:	May 2008

Intervention Details:

N/A

Detailed Description:

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

An essential treatment for almost all cardiovascular and pulmonary disorders is aerobic exercise training. However, fundamental information about the mechanisms underlying exercise training and its benefits is lacking for patients who have PH.

Subjects will be over the age of 21 years with a confirmed diagnosis of PH. The patients will be enrolled from sites throughout the Baltimore/Washington area and will receive their exercise training at INOVA Fairfax Hospital. 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 are experienced in PH.

There will be two primary treatment arms. Patients will be randomized to either aerobic exercise training plus education or education only. 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 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 in patients with PH to 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, oxygen on-kinetics, 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 including: International Physical Activity Questionnaire, Fatigue Severity Scale, SF-36, the Human Activity Profile, Stages of Exercise Adoption Scale, Self-Efficacy, Social Support Questionnaire, and Patient Health Questionnaire.

This study represents a unique opportunity to assess the affects of exercise on patients with PH and may open up valuable new treatment options for these patients.

Eligibility

Ages Eligible for Study:	21 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

INCLUSION CRITERIA:

PH Cohort: Subjects of this study will include individuals with PH who are referred for pulmonary rehabilitation. Patients with either primary or secondary hypertension will be included. The following list provides more specific inclusion criteria:

between age 21-75 years
WHO functional class II or III
no recent syncope or significant chest pain
no prior Pulmonary Rehabilitation received within the last 6 months.
physically inactive (no maintenance program for rehabilitation) within the last 6 months.
PAH diagnosed by right heart catheterization defined as resting pulmonary mean arterial pressure equal to or higher than 25 mmHg

Controls: The controls will include individuals who have never been diagnosed with primary or secondary PH and are apparently healthy or those that have veen diagnosed with primary or secondary PH but have participated in a pulmonary rehabilitation program within the last six months. Controls will be matched to the PH cohort for age, gender, and body mass.

between 21 - 75 years
physically inactive
no cardiorespiratory or pulmonary disease
no other diseases of the neurological, metabolic, renal, or musculoskeletal system
no medications that would influence aerobic capacity or treadmill performance

EXCLUSION CRITERIA FOR PH COHORT AND CONTROLS:

Since the goal is to examine exercise responses and adaptations as affected by PH, patients will have no other (except the primary disease in those with secondary PH) medical conditions that would impair aerobic capacity or the ability to engage in physical activity. These conditions would include any of those affecting the cardiovascular, pulmonary, metabolic, neurological, or musculoskeletal systems. Specific exclusion criteria for the PH and control cohorts are:

Significant restrictive or obstructive lung disease. Patients with a TLC and/or FVC less than 70 percent predicted, or a FEV1/FVC ratio less than 70 percent
Severe, symptomatic ischemic heart disease
History of left-sided heart failure or a documented pulmonary capillary wedge pressure greater than 15 mmHg.
Acute cor pulmonale
Dilated or hypertrophic cardiomyopathy
Non-idiopathic cardiomyopathy
Significant hepatic or renal dysfunction
Metastatic cancer with a life expectance of less than 6 months
Disabling stroke
Active substance abuse
Severe psychiatric disease
Patients on Antiretroviral Therapy
Other medications that limit exercise capacity or the ability to adapt to aerobic exercise training (Beta-blockers)
Uncontrolled diabetes mellitus with a history of DKA
Mitochondrial disease
Pregnancy
Ongoing tobacco use
Children: Individuals younger than 21 years will not be included in the protocol because reference ranges for normative aerobic capacity and aerobic fitness have not been established for these age ranges.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00678821

Contacts

Contact: Patient Recruitment and Public Liaison Office	(800) 411-1222	prpl@mail.cc.nih.gov
Contact: TTY	1-866-411-1010

Locations

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike	Recruiting
Bethesda, Maryland, United States, 20892
United States, Virginia
INOVA Fairfax Hospital	Recruiting
Falls Church, Virginia, United States, 22042-3300

Sponsors and Collaborators

National Institutes of Health Clinical Center (CC)

More Information

NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site

Publications:

Rich S, Dantzker DR, Ayres SM, Bergofsky EH, Brundage BH, Detre KM, Fishman AP, Goldring RM, Groves BM, Koerner SK, et al. Primary pulmonary hypertension. A national prospective study. Ann Intern Med. 1987 Aug;107(2):216-23.

Palevsky HI, Schloo BL, Pietra GG, Weber KT, Janicki JS, Rubin E, Fishman AP. Primary pulmonary hypertension. Vascular structure, morphometry, and responsiveness to vasodilator agents. Circulation. 1989 Nov;80(5):1207-21.

Christman BW, McPherson CD, Newman JH, King GA, Bernard GR, Groves BM, Loyd JE. An imbalance between the excretion of thromboxane and prostacyclin metabolites in pulmonary hypertension. N Engl J Med. 1992 Jul 9;327(2):70-5.

Study ID Numbers:	080133, 08-CC-0133
Study First Received:	May 14, 2008
Last Updated:	December 13, 2008
ClinicalTrials.gov Identifier:	NCT00678821
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

Exercise
Pulmonary Hypertension
Pulmonary Rehabilitation

Rehabilitation
Pulmonary Hypertension
Exercise

Study placed in the following topic categories:

Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Diseases
Vascular Diseases
Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009