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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00328484 |
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.
Condition | Intervention | Phase |
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Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive |
Behavioral: Lifestyle Activity Program Behavioral: Exercise Program |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Exercise and Disability in COPD Patients |
Estimated Enrollment: | 200 |
Study Start Date: | January 2002 |
Estimated Study Completion Date: | August 2007 |
Arms | Assigned Interventions |
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1: Experimental
Eleven month lifestyle activity program
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Behavioral: Lifestyle Activity 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.
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2: Active Comparator
Three month exercise program
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Behavioral: Exercise Program
The 3-month exercise program will consist of 36 1-hour exercise training sessions, conducted 3 times a week for 12 weeks.
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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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, North Carolina | |
Wake Forest University | |
Winston-Salem, North Carolina, United States, 27109 |
Principal Investigator: | Michael J. Berry, PhD | Wake Forest University |
Responsible Party: | Wake Forest University ( Michael J. Berry, PhD ) |
Study ID Numbers: | 387, R01 HL053755-09 |
Study First Received: | May 19, 2006 |
Last Updated: | December 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00328484 |
Health Authority: | United States: Federal Government |
COPD Chronic Obstructive Pulmonary Disease Exercise Emphysema Chronic Bronchitis |
Pulmonary Emphysema Emphysema Bronchitis, Chronic Lung Diseases, Obstructive Respiratory Tract Diseases |
Lung Diseases Respiration Disorders Chronic Disease Bronchitis Pulmonary Disease, Chronic Obstructive |
Disease Attributes Pathologic Processes |