The NIH Exercise Therapy for Advanced Lung Disease Trials: Response and Adaptation to Aerobic Exercise in Patients With Interstitial Lung Disease
Condition: Interstitial Lung Disease; Idiopathic Pulmonary Fibrosis; Interstitial Pneumonitis; Desquamative Interstitial Pneumonia
MeSH terms: Pneumonia; Lung Diseases; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Lung Diseases, Interstitial
Study type: Interventional

Summary: 
      Interstitial lung disease (ILD) is the result of over 200 etiological pathways arising from
      several different insults to the lung parenchyma: inhaled substances, drug side effects,
      connective tissue disease, infection, and malignancy. The disease can also be of idiopathic
      origin. If prolonged, the resulting inflammation causes permanent and progressive fibrotic
      reorganization of the parenchyma and small airways, which reduces the distensibility of the
      lung and impedes O2 and carbon dioxide (CO2) exchange.

      This study is a randomized controlled trial to determine the safety and efficacy of aerobic
      exercise for patients who have interstitial lung disease (ILD) uncomplicated by pulmonary
      hypertension. In an uncontrolled study, we observed more efficient cardiorespiratory
      function, increased physical work capacity, and improved health-related quality of life
      following aerobic exercise in this study population. Serious adverse events resulting from
      aerobic exercise training were not observed and our work to date has established plausibility
      for the efficacy of aerobic exercise training and its safety for patients with ILD.
    

Detailed description: 
      There are two primary treatment conditions. Patients with ILD are be randomized to either an
      intervention consisting of aerobic exercise training plus patient education or a control
      condition that includes patient education only. Aerobic exercise training will consist of a
      10-week regimen of supervised treadmill walking three times a week. The duration of the
      exercise sessions will progress from 30 minutes to 45 minutes per session over the 10 weeks,
      as tolerated. The intensity of the exercise will be determined based on results of a
      cardiopulmonary exercise test. Those randomized to control will not initially engage in
      aerobic exercise training. There will, however, be a secondary study: a crossover design in
      which subjects in the control group will complete the aerobic exercise regimen.

        -  Participants must be between the ages of 21 and 80 and live within a reasonable travel
           distance from the greater Washington D.C. area

        -  All pre and post testing will be conducted at the NIH Clinical Center in Bethesda,
           Maryland. Each testing session will last about 6 hours and will consist of a medical
           history and examination; six questionnaires on health, fatigue, activity, and mood;
           electrocardiogram, transthoracic echocardiogram, pulmonary function tests, six-minute
           walk test (6MWT); and urine pregnancy test (if applicable). Other required tests are:

        -  A maximum treadmill test: The exercise begins at an easy level and gradually increases
           until the participant says he or she can no longer continue or the investigator decides
           it is not safe to continue. Participants are fitted with a mask, electrodes and light
           sensors to measure how well the heart is working and how well the muscles use oxygen.

        -  An arterial occlusion muscle oxygenation capacity test:: During seated rest, a light
           sensor that measures the oxygen level in the muscle is placed on the calf while a
           pressure cuff will then be placed around the thigh. The cuff is rapidly inflated and
           held at a high pressure for up to 10 minutes and then deflated.

        -  A blood sample for complete blood count and Nt-ProBNP (a hormone that indicates damage
           to heart muscle).

        -  Aerobic exercise training and education may take place at either the NIH Clinical Center
           in Bethesda, Maryland, or the Pulmonary Rehabilitation Program at INOVA Fairfax Hospital
           in Falls Church, Virginia.
    

Intervention name(s): Aerobic Exercise Training (AET); Education
Intervention type(s): Other; Other
Intervention description(s): walking on a treadmill at vigorous intensity for up to 45 minutes; Weekly education
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: Exercise; Interstitial Lung Disease; Pulmonary Rehabilitation