The NIH Exercise Therapy for Advanced Lung Disease Trials: Response and Adaptation to Aerobic Exercise in Patients With Interstitial Lung Disease
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|ClinicalTrials.gov Identifier: NCT02019641|
Recruitment Status : Recruiting
First Posted : December 24, 2013
Last Update Posted : July 12, 2018
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 (AET) Other: Education||Phase 2|
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|
|Intervention Model:||Crossover Assignment|
|Primary Purpose:||Supportive Care|
|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|
AET 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 between 70 and 80% of the patient's heart rate reserve.
Other: Aerobic Exercise Training (AET)
walking on a treadmill at vigorous intensity for up to 45 minutes
Active Comparator: No AET
control will not engage in AET.
- 6MWT distance [ Time Frame: baseline, after 10 weeks, after 20 weeks (for crossover group) ]Distance walked in 6 minutes. 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.
- Treadmill cardiorespiratory exercise test (CPET) [ Time Frame: Baseline, after 10 weeks, after 20 weeks (for crossover group) ]Variables associated with pulmonary gas exchange, central circulatory function and muscle oxygenation during the CPET.
- Patient-reported outcomes [ Time Frame: Baseline, after 10 weeks, after 20 weeks (for crossover group) ]Self-reported questionnaires to include the St. George s Respiratory Questionnaire, Fatigue Severity Scale, SF36v2 Health Survey, Human Activity Profile, Profile of Mood States, and King s Brief Interstitial Lung Disease Health Status Questionnaire
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 ClinicalTrials.gov identifier (NCT number): NCT02019641
|Contact: Gayle S McCrossin, C.R.N.P.||(301) firstname.lastname@example.org|
|Contact: Leighton Chan, M.D.||(301) email@example.com|
|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 firstname.lastname@example.org|
|United States, Virginia|
|George Mason University||Recruiting|
|Fairfax, Virginia, United States, 22030|
|Contact: Randall Keyser, M.D. Not Listed email@example.com|
|INOVA Fairfax Hospital||Recruiting|
|Falls Church, Virginia, United States, 22042|
|Contact: Steven Nathan, M.D. 703-776-3610 firstname.lastname@example.org|
|Principal Investigator:||Leighton Chan, M.D.||National Institutes of Health Clinical Center (CC)|