Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00328484
Status:
COMPLETED
Last Update Posted:
2016-07-29
First Post:
2006-05-19
Brief Title:
Comparison of Two Programs to Encourage Physical Activity in Individuals With Chronic Obstructive Pulmonary Disease
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
Exercise and Disability in COPD Patients
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL053755-09 | NIH | None | httpsreporternihgovquickSearchR01HL053755-09 |