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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

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ClinicalTrials.gov Identifier: NCT02019641
Recruitment Status : Recruiting
First Posted : December 24, 2013
Last Update Posted : July 12, 2018
Sponsor:
Collaborators:
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 (AET) 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: Single (Investigator)
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


Arm Intervention/treatment
Experimental: AET
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

Other: Education
Education

Active Comparator: No AET
control will not engage in AET.
Other: Education
Education




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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



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
Criteria
  • 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


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 ClinicalTrials.gov identifier (NCT number): NCT02019641


Contacts
Contact: Gayle S McCrossin, C.R.N.P. (301) 443-9083 gayle.mccrossin@nih.gov
Contact: Leighton Chan, M.D. (301) 496-4733 chanle@mail.nih.gov

Locations
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    prpl@cc.nih.gov   
United States, Virginia
George Mason University Recruiting
Fairfax, Virginia, United States, 22030
Contact: Randall Keyser, M.D.    Not Listed    keyserr@mail.nih.gov   
INOVA Fairfax Hospital Recruiting
Falls Church, Virginia, United States, 22042
Contact: Steven Nathan, M.D.    703-776-3610    steven.nathan@inova.com   
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
George Mason University
Inova Fairfax Hospital
Investigators
Principal Investigator: Leighton Chan, M.D. National Institutes of Health Clinical Center (CC)

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT02019641     History of Changes
Other Study ID Numbers: 140027
14-CC-0027
First Posted: December 24, 2013    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 9, 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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

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