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

Primary Purpose

Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Lifestyle Activity Program
Exercise Program
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring COPD, Chronic Obstructive Pulmonary Disease, Exercise, Emphysema, Chronic Bronchitis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wake Forest University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Eleven month lifestyle activity program

Three month exercise program

Outcomes

Primary Outcome Measures

Amount of time engaged in moderate physical activity each week

Secondary Outcome Measures

Health related quality of life
Self-reported disability
Physical function
Exercise capacity

Full Information

First Posted
May 19, 2006
Last Updated
July 28, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00328484
Brief Title
Comparison of Two Programs to Encourage Physical Activity in Individuals With Chronic Obstructive Pulmonary Disease
Official Title
Exercise and Disability in COPD Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive
Keywords
COPD, Chronic Obstructive Pulmonary Disease, Exercise, Emphysema, Chronic Bronchitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
318 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Eleven month lifestyle activity program
Arm Title
2
Arm Type
Active Comparator
Arm Description
Three month exercise program
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Activity Program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise Program
Intervention Description
The 3-month exercise program will consist of 36 1-hour exercise training sessions, conducted 3 times a week for 12 weeks.
Primary Outcome Measure Information:
Title
Amount of time engaged in moderate physical activity each week
Time Frame
Measured at Year 1
Secondary Outcome Measure Information:
Title
Health related quality of life
Time Frame
Measured at Year 1
Title
Self-reported disability
Time Frame
Measured at Year 1
Title
Physical function
Time Frame
Measured at Year 1
Title
Exercise capacity
Time Frame
Measured at Year 1

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J. Berry, PhD
Organizational Affiliation
Wake Forest University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27109
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16458075
Citation
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. doi: 10.1016/j.cct.2005.11.011. Epub 2006 Feb 2.
Results Reference
background
PubMed Identifier
15056389
Citation
Katula 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. doi: 10.1186/1477-7525-2-18.
Results Reference
background
PubMed Identifier
16778269
Citation
Berry 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. doi: 10.1378/chest.129.6.1516.
Results Reference
background
PubMed Identifier
20347286
Citation
Berry MJ, Rejeski WJ, Miller ME, Adair NE, Lang W, Foy CG, Katula JA. A lifestyle activity intervention in patients with chronic obstructive pulmonary disease. Respir Med. 2010 Jun;104(6):829-39. doi: 10.1016/j.rmed.2010.02.015. Epub 2010 Mar 26.
Results Reference
derived

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

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