Aerobic Exercise in Patients With Pulmonary Hypertension

NCT00678821 | Completed Phase 2

• 2 other identifiers: 08013308-CC-0133
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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).
• 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

Keywords

Interstitial Lung Disease; Pulmonary Rehabilitation

Outcome Measures

Primary Outcomes (4)

• Pre and post exercise training CPET

  CPET variables

  10 wks

• Accelerometry-based activity

  Physical activity participation

  10 wks

• 6 minute walk distance

  total meters walked in 6 minutes

  10 wks

• Quality of life and functional measures

  self-report questionnaires

  10 wks

Study Arms (2)

1

EXPERIMENTAL

Patients with PH will be randomized to either aerobic exercise training plus education (AET) or education only (Ed-only) treatments

Other: Aerobic exercise

2

ACTIVE COMPARATOR

A comparison group of patients with ILD who do not have secondary PH (ILD-only) will also undergo the AET arm

Other: Aerobic exercise

Interventions

Aerobic exercise OTHER

Supervised aerobic exercise and educational lectures for 10 weeks

1; 2

Eligibility Criteria

• Age: 21 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between age 21-82 years
• WHO functional class II or III, will accept WHO functional class I and IV based on 6 minute walk test results (less than or equal to 400 meters for Class I and greater than or equal to 50 meters for Class IV)
• No recent syncope or significant chest pain
• No prior Pulmonary Rehabilitation received within the last 6 months.
• Physically inactive, no participation in a structured exercise program 3 or more days a week for over 30 minutes at each session including pulmonary rehabilitation maintenance within the last 6 months.
• Patients may qualify if they have any one of the following conditions:
• PAH diagnosed by right heart catheterization defined as resting pulmonary mean arterial pressure equal to or higher than 25 mmHg
• Interstitial lung disease, including idiopathic pulmonary fibrosis (IPF), non-specific pulmonary fibrosis (NSPF), sarcoidosis or other form of chronic lung fibrosis will be based on clinical context via clinic note from primary pulmonologist and an echo within one year of enrollment showing an RVSP \<40mmHg.
• If RVSP is lower than 40mmHg patients with interstitial lung disease will be enrolled without the need for a right heart catheterization.
• If RVSP is indeterminate on an echo procedure performed within a year of enrollment, the patient will undergo another echo test at The National Institutes of Health, Echocardiogram Laboratory.
• Only if RVSP is unable to be estimated on an echo at NIH, the absence of the following abnormalities on echo will be used: right ventricular enlargement, right ventricular hypertrophy, paradoxical movement of interventricular septum and/or altered pulmonary flow velocity. If RVSP is unable to be estimated and these abnormalities are absent on echo, the patient will be enrolled as an ILD-only patient. If any of these echocardiographic abnormalities are present the patient will not be enrolled until the results of a right heart catheterization can be obtained to verify the absence of pulmonary hypertension.
• Healthy Controls: The controls will include individuals who have never been diagnosed with primary or secondary PH and are apparently healthy. Controls will be matched to the PH cohort for age, gender, and body mass.
• Between 21 82 years
• Physically inactive, no participation in a structured exercise program 3 or more days a week for over 30 minutes at each session.
• No cardiorespiratory or pulmonary disease

You may not qualify if:

• Significant Restrictive or Obstructive Lung Disease with a FEV1/FVC ratio less than or equal to 65 percent
• Diagnosis of ischemic heart disease
• Left ventricular dysfunction with the ejection fraction less than 40 or a documented pulmonary capillary wedge pressure greater than or equal to 18 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
• Uncontrolled diabetes mellitus with a history of DKA
• Mitochondrial disease
• Pregnancy

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead
• George Mason University: collaborator
• Inova Fairfax Hospital: collaborator

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• Keyser RE, Christensen EJ, Chin LM, Woolstenhulme JG, Drinkard B, Quinn A, Connors G, Weir NA, Nathan SD, Chan LE. Changes in fatigability following intense aerobic exercise training in patients with interstitial lung disease. Respir Med. 2015 Apr;109(4):517-25. doi: 10.1016/j.rmed.2015.01.021. Epub 2015 Feb 7.

  PMID: 25698651 BACKGROUND

• Chan L, Chin LMK, Kennedy M, Woolstenhulme JG, Nathan SD, Weinstein AA, Connors G, Weir NA, Drinkard B, Lamberti J, Keyser RE. Benefits of intensive treadmill exercise training on cardiorespiratory function and quality of life in patients with pulmonary hypertension. Chest. 2013 Feb 1;143(2):333-343. doi: 10.1378/chest.12-0993.

  PMID: 22922554 BACKGROUND

• Weinstein AA, Chin LM, Keyser RE, Kennedy M, Nathan SD, Woolstenhulme JG, Connors G, Chan L. Effect of aerobic exercise training on fatigue and physical activity in patients with pulmonary arterial hypertension. Respir Med. 2013 May;107(5):778-84. doi: 10.1016/j.rmed.2013.02.006. Epub 2013 Mar 7.

  PMID: 23478192 BACKGROUND

• Woolstenhulme JG, Guccione AA, Herrick JE, Collins JP, Nathan SD, Chan L, Keyser RE. Left Ventricular Function Before and After Aerobic Exercise Training in Women With Pulmonary Arterial Hypertension. J Cardiopulm Rehabil Prev. 2019 Mar;39(2):118-126. doi: 10.1097/HCR.0000000000000397.

  PMID: 30624371 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Hypertension, Pulmonary; Lung Diseases, Interstitial

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Leighton Chan, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2008
• First Posted: May 16, 2008
• Study Start: June 12, 2008
• Primary Completion: September 23, 2015
• Study Completion: September 23, 2015
• Last Updated: May 1, 2026

Record last verified: 2025-12-03

Locations

US (1)