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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

14-CC-0027

Sponsoring Institute

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 21
Max Age: 80

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Exercise;
Interstitial Lung Disease;
Pulmonary Rehabilitation

Recruitment Keyword(s)

None

Condition(s)

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

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Other: Aerobic Exercise Training
Other: Education

Supporting Site

NIH Clinical CenterGeorge Mason UniversityInova Fairfax Hospital

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.

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Eligibility

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


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Citations:

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.

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.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Leighton Chan, M.D.
National Institutes of Health Clinical Center (CC)
BG 10-CRC RM 1-1469
10 CENTER DR
BETHESDA MD 20814
(301) 496-4733
chanle@mail.nih.gov

Anne B. Quinn, C.R.N.P.
National Institutes of Health Clinical Center (CC)
BG 10-CRC RM 1-1469
10 CENTER DR
BETHESDA MD 20814
(301) 443-9083
quinna@mail.nih.gov

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT02019641

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