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

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.

- 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