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

NCT02019641 | Completed Results

• 2 other identifiers: 14002714-CC-0027
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Interstitial Lung Disease; Idiopathic Pulmonary Fibrosis; Interstitial Pneumonitis; Desquamative Interstitial Pneumonia

Keywords

Exercise; Interstitial Lung Disease; Pulmonary Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in 6-minute Walk Test Distance (6MWD)

  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

Study Arms (2)

Aerobic Exercise Intervention (AET+)

EXPERIMENTAL

Participant with interstitial lung disease performed aerobic exercise three times a week plus weekly education for 10 weeks

Other: Aerobic Exercise Training (AET); Other: Education

Control Group (CON)

ACTIVE COMPARATOR

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

Interventions

Aerobic Exercise Training (AET) OTHER

walking on a treadmill at vigorous intensity for up to 45 minutes

Aerobic Exercise Intervention (AET+)

Education OTHER

Weekly education

Aerobic Exercise Intervention (AET+); Control Group (CON)

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead
• Inova Fairfax Hospital: collaborator

Study Sites (2)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

INOVA Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Related Publications (5)

• Chan L, Chin LMK, Kennedy M, Woolstenhulme JG, Nathan SD, Weinstein AA, Connors G, Weir NA, Drinkard B, Lamberti J, Keyser RE. Benefits of intensive treadmill exercise training on cardiorespiratory function and quality of life in patients with pulmonary hypertension. Chest. 2013 Feb 1;143(2):333-343. doi: 10.1378/chest.12-0993.

  PMID: 22922554 BACKGROUND

• Keyser RE, Woolstenhulme JG, Chin LM, Nathan SD, Weir NA, Connors G, Drinkard B, Lamberti J, Chan L. Cardiorespiratory function before and after aerobic exercise training in patients with interstitial lung disease. J Cardiopulm Rehabil Prev. 2015 Jan-Feb;35(1):47-55. doi: 10.1097/HCR.0000000000000083.

  PMID: 25313451 BACKGROUND

• Keyser RE, Christensen EJ, Chin LM, Woolstenhulme JG, Drinkard B, Quinn A, Connors G, Weir NA, Nathan SD, Chan LE. Changes in fatigability following intense aerobic exercise training in patients with interstitial lung disease. Respir Med. 2015 Apr;109(4):517-25. doi: 10.1016/j.rmed.2015.01.021. Epub 2015 Feb 7.

  PMID: 25698651 BACKGROUND

• Weinstein AA, Chin LM, Keyser RE, Kennedy M, Nathan SD, Woolstenhulme JG, Connors G, Chan L. Effect of aerobic exercise training on fatigue and physical activity in patients with pulmonary arterial hypertension. Respir Med. 2013 May;107(5):778-84. doi: 10.1016/j.rmed.2013.02.006. Epub 2013 Mar 7.

  PMID: 23478192 BACKGROUND

• Morris ZV, Chin LMK, Chan L, Guccione AA, Ahmad A, Keyser RE. Cardiopulmonary exercise test indices of respiratory buffering before and after aerobic exercise training in women with pulmonary hypertension: Differentiation by magnitudes of change in six-minute walk test performance. Respir Med. 2020 Apr;164:105900. doi: 10.1016/j.rmed.2020.105900. Epub 2020 Feb 25.

  PMID: 32217288 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Lung Diseases, Interstitial; Idiopathic Pulmonary Fibrosis; Interstitial Pneumonitis, Desquamative, Familial; Motor Activity

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Pulmonary Fibrosis; Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Limitations and Caveats

Study was terminated early due to the COVID-19 pandemic.

Results Point of Contact

• Title: Leighton Chan
• Organization: Clinical Center

chanle@mail.nih.gov

+1 301 496 4733

Study Officials

• Leighton Chan, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2013
• First Posted: December 24, 2013
• Study Start: May 23, 2015
• Primary Completion: April 2, 2020
• Study Completion: May 24, 2023
• Last Updated: June 27, 2023
• Results First Posted: June 27, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The data will become available when the resources become available to perform the deidentification. The data will available until Jan. 1st, 2028.
• 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.

Locations

US (2)