N/A N=34 Randomized Single-blind Supportive Care

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

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

Bottom Line

View on ClinicalTrials.gov: NCT02019641 ↗

Enrolled (actual)

Serious AEs

6.1%

Results posted

Jun 2023

Primary outcome: Primary: Change in 6-minute Walk Test Distance (6MWD) — 46.5; 23.2 Meters

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Aerobic Exercise Training (AET) (Other); Education (Other)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: National Institutes of Health Clinical Center (CC)
Primary completion: Apr 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in 6-minute Walk Test Distance (6MWD)	46.5; 23.2	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02019641). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.