Aerobic Exercise in Patients With Pulmonary Hypertension
Condition: Pulmonary Hypertension; Interstitial Lung Disease
MeSH terms: Lung Diseases; Hypertension, Pulmonary; Lung Diseases, Interstitial; Hypertension
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      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.
    

Intervention name(s): Aerobic exercise
Intervention type(s): Other
Intervention description(s): Supervised aerobic exercise and educational lectures for 10 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: Interstitial Lung Disease; Pulmonary Rehabilitation