Exercise and Disability in COPD Patients
Chronic obstructive pulmonary disease (COPD) is a chronic lung disease. Symptoms include shortness of breath, wheezing, and difficulty exercising. Increasing exercise and physical activity may relieve the symptoms of COPD and may also slow the progression of the disease. The purpose of this study is to evaluate the effectiveness of a lifestyle activity program versus a traditional exercise program at increasing the amount of physical activity among individuals with COPD.
Description
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.
Status: Active, not recruiting (Phase 3). Started on January 1st, 2002. Ended on August 1st, 2007.
Enrollment: 200 subjects
Study Type: Interventional
Study Design:
- Treatment
- Randomized
- Single Blind (Subject)
- Active Control
- Parallel Assignment
- Efficacy Study
Conditions:
Interventions:
- Behavioral: Lifestyle Activity Program
- Behavioral: Exercise Program
Eligibility
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
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
- Gender
Both
- Mininum Age
N/A
- Maximum Age
N/A
- Healthy Volunteers
No
Resources
Source: National Heart, Lung, and Blood Institute (NHLBI)
Authority: United States: Federal Government
Locations
-
Wake Forest University
Winston-Salem
North Carolina
27109
United States
Officials
Michael J. Berry, PhD (Principal Investigator, Wake Forest University)
Sponsors
National Heart, Lung, and Blood Institute (NHLBI) (Lead Sponsor)
References
Foy CG, Wickley KL, Adair N, Lang W, Miller ME, Rejeski WJ, Woodard CM, Berry MJ. The Reconditioning Exercise and Chronic Obstructive Pulmonary Disease Trial II (REACT II): rationale and study design for a clinical trial of physical activity among individuals with chronic obstructive pulmonary disease. Contemp Clin Trials. 2006 Apr;27(2):135-46. Epub 2006 Feb 2.
PMID: 16458075.
Check for Full TextKatula JA, Rejeski WJ, Wickley KL, Berry MJ. Perceived difficulty, importance, and satisfaction with physical function in COPD patients. Health Qual Life Outcomes. 2004 Mar 31;2:18.
PMID: 15056389.
Check for Full TextBerry MJ, Adair NE, Rejeski WJ. Use of peak oxygen consumption in predicting physical function and quality of life in COPD patients. Chest. 2006 Jun;129(6):1516-22.
PMID: 16778269.
Check for Full Text
Links
None.
- Date Verified
- December 1st, 2007
- First Received
- December 17th, 2007
- Last Changed
- December 17th, 2007
Information obtained from ClinicalTrials.gov on July 15, 2008. Link to the current ClinicalTrials.gov record.
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