Protocol Number: 08-CC-0133

Title:

Response and Adaptation to Aerobic Exercise in Patients with Pulmonary Hypertension: Initial Studies for Establishing Guidelines

Number:

08-CC-0133

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.

-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.

Sponsoring Institute:

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): Children

Eligibility 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.

Special Instructions:

Currently Not Provided

Keywords:

Exercise

Pulmonary Hypertension

Pulmonary Rehabilitation

Rehabilitation

Recruitment Keyword(s):

Pulmonary Hypertension

Exercise

Condition(s):

Hypertension, Pulmonary

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

Procedure/Surgery: Excerise Training

Procedure/Surgery: Patient Education (Placebo)

Supporting Site:

Warren G. Magnuson Clinical Center

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

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.

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