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

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00328484
First received: May 19, 2006
Last updated: February 17, 2009
Last verified: February 2009

May 19, 2006
February 17, 2009
January 2002
July 2007   (final data collection date for primary outcome measure)
Amount of time engaged in moderate physical activity each week [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
Amount of time engaged in moderate physical activity each week (measured at Year 1)
Complete list of historical versions of study NCT00328484 on ClinicalTrials.gov Archive Site
  • Health related quality of life [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
  • Self-reported disability [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
  • Physical function [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
  • Exercise capacity [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
  • Health related quality of life
  • Self-reported disability
  • Physical function
  • Exercise capacity (all measured at Year 1)
Not Provided
Not Provided
 
Comparison of Two Programs to Encourage Physical Activity in Individuals With Chronic Obstructive Pulmonary Disease
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Pulmonary Disease, Chronic Obstructive
  • Lung Diseases, Obstructive
  • 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.
  • 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.
  • Experimental: 1
    Eleven month lifestyle activity program
    Intervention: Behavioral: Lifestyle Activity Program
  • Active Comparator: 2
    Three month exercise program
    Intervention: Behavioral: Exercise Program

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
318
July 2007
July 2007   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00328484
387, R01 HL053755-09
Yes
Michael J. Berry, PhD, Wake Forest University
National Heart, Lung, and Blood Institute (NHLBI)
Not Provided
Principal Investigator: Michael J. Berry, PhD Wake Forest School of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP