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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by National Institutes of Health Clinical Center (CC)
Sponsor:
Collaborators:
George Mason University
Inova Fairfax Hospital
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT02019641
First received: December 20, 2013
Last updated: November 25, 2015
Last verified: August 2015

December 20, 2013
November 25, 2015
November 2013
July 2019   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
6MWT distance (most frequently used measured of physical performance for evaluating patients with ILD and other advanced lung diseases). MCID for 6MWT distance has been determined to be approximately 30 meters in ILD [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT02019641 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ]
Peak work rate on the treadmill cardiopulmonary exercise test, and performance and perceived fatigability. We will also examine subject's acceptance onto transplant lists and patient mortality. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
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The NIH Exercise Therapy for Advanced Lung Disease Trials: Response and Adaptation to Aerobic Exercise in Patients With Interstitial Lung Disease
The NIH Exercise Therapy for Advanced Lung Disease Trials: Response and Adaptation to Aerobic Exercise in Patients With Interstitial Lung Disease

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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Interstitial Lung Disease
  • Idiopathic Pulmonary Fibrosis
  • Interstitial Pneumonitis
  • Desquamative Interstitial Pneumonia
  • Other: Aerobic Exercise Training
  • Other: Education
  • Active Comparator: Group 1
    10 weeks of education and exercisse concurrently
    Interventions:
    • Other: Aerobic Exercise Training
    • Other: Education
  • Active Comparator: Group 2
    10 weeks of education followed by 10 weeks of exercise
    Interventions:
    • Other: Aerobic Exercise Training
    • Other: Education

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
July 2020
July 2019   (final data collection date for primary outcome measure)
  • INCLUSION CRITERIA:

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).

EXCLUSION CRITERIA:

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

Pregnancy

Ongoing tobacco use

Acceptance onto a lung transplant waiting list

Active participation in ILD drug trials

Inability to read English

Both
21 Years to 80 Years
No
Contact: Anne B Quinn, R.N. (301) 443-9083 quinna@cc.nih.gov
Contact: Leighton Chan, M.D. (301) 496-4733 chanle@mail.nih.gov
United States
 
NCT02019641
140027, 14-CC-0027
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National Institutes of Health Clinical Center (CC)
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)
National Institutes of Health Clinical Center (CC)
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP