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

June 2, 2023 updated by: National Institutes of Health Clinical Center (CC)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aerobic Exercise Intervention (AET+)
Participant with interstitial lung disease performed aerobic exercise three times a week plus weekly education for 10 weeks
Other: Aerobic Exercise Training (AET)
walking on a treadmill at vigorous intensity for up to 45 minutes
Other: Education
Weekly education
Active Comparator: Control Group (CON)
Participant with interstitial lung disease performed weekly education for 10 weeks, then crossed over to perform aerobic exercise three times a week for 10 weeks
Other: Education
Weekly education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 6-minute Walk Test Distance (6MWD)
Time Frame: Before and after 10 weeks
The 6-minute walk test (6MWT) is a measure of physical capacity and subjects are instructed to walk as far as possible around a pre-measured walking course over a time period of six minutes. The 6-minute walk test distance (6MWD) is the total distance walked in meters during the 6MWT and greater distance walked means better physical capacity. This outcome is reported as the difference between time-points (post- minus pre-10 weeks).
Before and after 10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, after 10 weeks, after 20 weeks (for crossover group)
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, SF-36v2 Health Survey, Human Activity Profile, Profile of Mood States, and King s Brief Interstitial Lung Disease Health Status Questionnaire
Baseline, after 10 weeks, after 20 weeks (for crossover group)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institutes of Health Clinical Center (CC)

Collaborators

Inova Fairfax Hospital

Investigators

  • Principal Investigator: Leighton Chan, M.D., National Institutes of Health Clinical Center (CC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2015

Primary Completion (Actual)

April 2, 2020

Study Completion (Actual)

May 24, 2023

Study Registration Dates

First Submitted

December 20, 2013

First Submitted That Met QC Criteria

December 20, 2013

First Posted (Estimated)

December 24, 2013

Study Record Updates

Last Update Posted (Actual)

June 27, 2023

Last Update Submitted That Met QC Criteria

June 2, 2023

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 140027
  • 14-CC-0027

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Only de-identified scientific data (e.g., 6 minute-walk test distance, clinical tests, survey questionnaires) will be made available at the discretion of the Principle Investigator.

IPD Sharing Time Frame

The data will become available when the resources become available to perform the deidentification. The data will available until Jan. 1st, 2028.

IPD Sharing Access Criteria

De-identified scientific data may be shared directly with those requesting it as deemed appropriate by the Principle Investigator on a resource available basis.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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