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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
  Purpose

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
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Behavioral: Lifestyle Activity Program
Behavioral: Exercise Program
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Exercise and Disability in COPD Patients

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Amount of time engaged in moderate physical activity each week [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 318
Study Start Date: January 2002
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Eleven month lifestyle activity program
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.
Active Comparator: 2
Three month exercise program
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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00328484

Locations
United States, North Carolina
Wake Forest University
Winston-Salem, North Carolina, United States, 27109
Sponsors and Collaborators
Investigators
Principal Investigator: Michael J. Berry, PhD Wake Forest School of Medicine
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael J. Berry, PhD, Wake Forest University
ClinicalTrials.gov Identifier: NCT00328484     History of Changes
Other Study ID Numbers: 387, R01 HL053755-09
Study First Received: May 19, 2006
Last Updated: February 17, 2009
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
COPD
Chronic Obstructive Pulmonary Disease
Exercise
Emphysema
Chronic Bronchitis

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 23, 2014