Comparison of Two Programs to Encourage Physical Activity in Individuals With Chronic Obstructive Pulmonary Disease

COPD is a disease in which the lung airways are partly damaged and obstructed, making it
difficult to breathe. It is the fourth leading cause of death in the United States.
Cigarette smoking is the most common cause of COPD; however, breathing in other types of
lung irritants, including pollution, dust, and chemicals, over a long period of time may
also cause or contribute to COPD. The primary symptoms of COPD, exercise intolerance and
shortness of breath, often result in physical activity limitations, which may lead to a
decreased quality of life. While COPD is a chronic, incurable disease, individuals who
incorporate exercise and physical activity into their daily lifestyle may reduce the
symptoms and slow the progression of the disease. The purpose of this study is to compare
the effectiveness of an overall lifestyle activity program versus a traditional exercise
program on physical activity in individuals with COPD. The study will also evaluate the
impact of the two programs on exercise capacity, physical function, self-reported
disability, and health-related quality of life.

Participants with COPD will be randomly assigned to either an 11-month lifestyle activity
program or a traditional 3-month exercise program. The lifestyle activity program will
consist of 35 exercise and counseling sessions spaced over 11 months. This program will use
cognitive-behavioral strategies to encourage physical activity at home. Participants will
receive information on how to deal with COPD symptoms (including shortness of breath),
goal-setting, social support, and motivation. Participants will also receive follow-up
telephone calls from the program staff for additional support. The 3-month exercise program
will consist of 36 1-hour exercise training sessions, conducted 3 times a week for 12 weeks.

All participants will attend 4 baseline study visits at which their medical history will be
reviewed and standardized questionnaires will be completed to assess mood, depression,
social factors, COPD symptoms, and physical activity levels. Participants will undergo a
physical examination; a blood draw for laboratory testing; and spirometry, lung function,
exercise, and strength tests. These measures will be assessed again at 3, 6, and 12 months;
the 3- and 12-month assessments will occur over four study visits, and the 6-month
assessment will occur over two study visits.

Inclusion Criteria:

- Expiratory airflow limitation such that FEV1/FVC is less than or equal to 70% and the
FEV₁ is greater than or equal to 20% of the predicted amount

- Physical disability, including self-reported difficulty with walking a city block,
climbing stairs, lifting and carrying groceries, performing household activities such
as cleaning and doing yard work, or getting out of a chair

- Currently lives within a 35-mile radius of Wake Forest University

- Plans to reside in Forsyth County, North Carolina for the entire study

- Willing and able to participate in all aspects of the trial

Exclusion Criteria:

- Undergoing treatment for cancer

- Severe congestive heart failure

- Stroke

- Peripheral vascular disease

- Coronary artery disease

- Valvular heart disease

- Major psychiatric disease

- Severe anemia

- Liver or kidney disease

- Uncontrolled diabetes or hypertension

- Orthopedic impairment

- Blindness or deafness

- Oxygen desaturation during exercise to less than 90%, at a heart rate less than 50%
of predicted maximum for participant's age and without supplemental oxygen

- Inability to exercise due to a physical disability or positive exercise stress test

- Alcohol consumption of greater than two drinks per day in the 2 months prior to study
entry