Healia Clinical Trials Information Database

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.

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.

Status: Active, not recruiting (Phase 3). Started on January 1st, 2002. Ended on August 1st, 2007.

Enrollment: 200 subjects

Study Type: Interventional

Study Design:

  • Treatment
  • Randomized
  • Single Blind (Subject)
  • Active Control
  • Parallel Assignment
  • Efficacy Study

Conditions:

Interventions:

  • Behavioral: Lifestyle Activity Program
  • Behavioral: Exercise Program

Eligibility

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

Gender

Both

Mininum Age

N/A

Maximum Age

N/A

Healthy Volunteers

No


Resources

Source: National Heart, Lung, and Blood Institute (NHLBI)

Authority: United States: Federal Government

Locations

  • Wake Forest University
    Winston-Salem
    North Carolina
    27109
    United States

Officials

  • Michael J. Berry, PhD (Principal Investigator, Wake Forest University)

Sponsors

  • National Heart, Lung, and Blood Institute (NHLBI) (Lead Sponsor)

References

  • 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. Epub 2006 Feb 2.
    PMID: 16458075.
    Check for Full Text

  • 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.
    PMID: 15056389.
    Check for Full Text

  • 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.
    PMID: 16778269.
    Check for Full Text

Links

None.


Date Verified
December 1st, 2007
First Received
December 17th, 2007
Last Changed
December 17th, 2007

Information obtained from ClinicalTrials.gov on July 15, 2008. Link to the current ClinicalTrials.gov record.


All data in the Healia Clinical Trials Information Database and content displayed by the Healia Clinical Trials Search Engine are licensed from the National Institutes of Health (National Library of Medicine), which collects and maintains the data.

The Healia Clinical Trials Search Engine searches the data set at clinicaltrials.gov, providing up-to-date information about current clinical trials. In the Healia Clinical Trials Database you can find information on new experimental drugs, medical devices, and other types of treatments for all types of diseases. Each clinical trial description includes information about the phase of the trial (phase I, phase II, or phase III), the trial’s methods, such as whether it is a randomized, placebo controlled, double blind study, and the status of the trial including whether or not the trial is currently enrolling new participants.


Advertisements

About | Privacy Policy | Business Solutions | Advertise | Contact | Add Healia to your site

©2012. Healia / Meredith Corporation  

Use of this site constitutes acceptance of our Terms of Service and Privacy Policy. All content on this Web site, including medical opinion and any other health-related information, is for informational purposes only and should not be used for a specific diagnosis or individual treatment plan for any situation. Use of this site and the information contained herein does not create a doctor-patient relationship. Always seek the direct advice of your doctor in connection with any questions or issues you may have regarding your own health or the health of others.