The NIH Exercise Therapy for Advanced Lung Disease Trials: Response and Adaptation to Aerobic Exercise in Patients With Interstitial Lung Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02019641
Recruitment Status : Recruiting
First Posted : December 24, 2013
Last Update Posted : May 9, 2018
George Mason University
Inova Fairfax Hospital
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)

Brief 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 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.

Condition or disease Intervention/treatment Phase
Interstitial Lung Disease Idiopathic Pulmonary Fibrosis Interstitial Pneumonitis Desquamative Interstitial Pneumonia Other: Aerobic Exercise Training Other: Education Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The NIH Exercise Therapy for Advanced Lung Disease Trials: Response and Adaptation to Aerobic Exercise in Patients With Interstitial Lung Disease
Study Start Date : December 20, 2013
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Active Comparator: Group 1
10 weeks of education and exercisse concurrently
Other: Aerobic Exercise Training
Other: Education
Active Comparator: Group 2
10 weeks of education followed by 10 weeks of exercise
Other: Aerobic Exercise Training
Other: Education

Primary Outcome Measures :
  1. 6MWT distance (most frequently used measured of physical performance for evaluating patients with ILD and other advanced lung diseases). [ Time Frame: 0 weeks and after 10 weekds of exercise training ]

Secondary Outcome Measures :
  1. Peak work rate on a treadmill cardiopulmonary exercise test and performance and perceived fatigability. [ Time Frame: 0 weeks, after 10 weeks of exercise training In Group 1, and after 10 weeks of education in Group 2 ]
  2. Cardiorespiratory capacity, including AT-time and muscle oxygenation capacity. [ Time Frame: 0 weeks, after 10 weeks of exercise training In Group 1, and after 10 weeks of education in Group 2 ]
  3. Fatigue severity, participation in physical activities, health-related quality of life scores, and changes in mood. [ Time Frame: 0 weeks, after 10 weeks of exercise training In Group 1, and after 10 weeks of education in Group 2 ]
  4. Frequency and type of exercise continued after study participation; rate of hospitalization; acceptance onto lung transplant lists; and patient mortality. Participates will be followed monthly over one year after completion of exercise. [ Time Frame: 1 month post training and monthly up to 12 months post training ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

A diagnosis of interstitial lung disease, including idiopathic pulmonary fibrosis (IPF), non-specific interstitial pneumonitis (NSIP), sarcoidosis, or other form of chronic lung fibrosis based on clinical context via clinic note from a pulmonologist.

Individuals with ILD referred for pulmonary rehabilitation who are 21-80 years of age and live in the Washington metropolitan area.

No episodes of fainting or significant chest pain for at least one month.

No prior pulmonary rehabilitation received within the last 6 months and not currently in a maintenance program.

Physically inactive (no participation in a structured exercise program as defined as more than 30 minutes of exercise 3 or more days a week within the last 6 months).


Other medical conditions that would impair aerobic capacity or the ability to engage in physical activity, including other pulmonary, cardiovascular, neurological, musculoskeletal or metabolic conditions

Other medical conditions that may pose a risk to exercise testing or training as determined by the investigators (for example, peripheral vascular disease)

Diagnosis of pulmonary hypertension

Inability to maintain a resting oxygen saturation greater than or equal to 90% SpO2, measured by pulse oximetry on supplemental oxygen

Inability to complete a treadmill cardiopulmonary exercise test.

Significant hepatic or renal dysfunction.

Metastatic cancer with a life expectancy of less than one year.

Active substance abuse.

Severe psychiatric disease

Antiretroviral therapy


Ongoing tobacco use

Acceptance onto a lung transplant waiting list

Active participation in ILD drug trials

Inability to read English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02019641

Contact: Anne B Quinn, C.R.N.P. (301) 443-9083
Contact: Leighton Chan, M.D. (301) 496-4733

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010   
United States, Virginia
INOVA Fairfax Hospital Recruiting
Falls Church, Virginia, United States, 22042
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
George Mason University
Inova Fairfax Hospital
Principal Investigator: Leighton Chan, M.D. National Institutes of Health Clinical Center (CC)

Additional Information:
Responsible Party: National Institutes of Health Clinical Center (CC) Identifier: NCT02019641     History of Changes
Other Study ID Numbers: 140027
First Posted: December 24, 2013    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: April 30, 2018

Keywords provided by National Institutes of Health Clinical Center (CC):
Interstitial Lung Disease
Pulmonary Rehabilitation

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Genetic Diseases, Inborn
Respiratory Tract Diseases
Respiratory Tract Infections