Randomized Controlled Trial of Exercise Training in Patients With COPD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00012792
First received: March 14, 2001
Last updated: April 16, 2014
Last verified: April 2014

March 14, 2001
April 16, 2014
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Complete list of historical versions of study NCT00012792 on ClinicalTrials.gov Archive Site
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Randomized Controlled Trial of Exercise Training in Patients With COPD
Randomized Controlled Trial of Exercise Training in Patients With COPD

Chronic obstructive pulmonary disease (COPD) is one of the most common chronic illnesses in the adult population and accounts for approximately 25,000 discharges from VA hospitals in a calendar year. In addition to the burden put on the health care system, COPD is a disabling condition that adversely affects functional status and quality of life (QOL). Several reports have suggested that exercise training programs can reduce the frequency of hospitalization for COPD; however, these reports have important methodological limitations and such programs have not been widely implemented in the VA health care system. Although the underlying lung pathology of COPD may be unalterable, physical reconditioning has been clearly demonstrated to improve cardiorespiratory status in COPD patients. These physiologic changes have the potential to substantially improve QOL and reduce functional disability. Moreover, improved cardiorespiratory reserve may decrease the utilization of health care resources during mild to moderate exacerbation of COPD.

Background:

Chronic obstructive pulmonary disease (COPD) is one of the most common chronic illnesses in the adult population and accounts for approximately 25,000 discharges from VA hospitals in a calendar year. In addition to the burden put on the health care system, COPD is a disabling condition that adversely affects functional status and quality of life (QOL). Several reports have suggested that exercise training programs can reduce the frequency of hospitalization for COPD; however, these reports have important methodological limitations and such programs have not been widely implemented in the VA health care system. Although the underlying lung pathology of COPD may be unalterable, physical reconditioning has been clearly demonstrated to improve cardiorespiratory status in COPD patients. These physiologic changes have the potential to substantially improve QOL and reduce functional disability. Moreover, improved cardiorespiratory reserve may decrease the utilization of health care resources during mild to moderate exacerbation of COPD.

Objectives:

The overall goal of this project is to determine whether exercise training leads to a reduction in chronic institutionalization, acute hospitalization, and outpatient physician visits and to improved functional status and QOL in patients with COPD. The following specific objectives will be accomplished: 1) test the hypothesis that the addition of exercise training to usual care reduces use of health care services over a one-year follow-up period; and 2) test the hypothesis that exercise training leads to improvements in functional status and QOL.

Methods:

Hypotheses will be tested by means of a randomized controlled trial involving subjects with COPD (aged 50-79 years) who receive care at two Boston area VA hospitals. Subjects randomized to the intervention group receive an eight-week program of thrice-weekly exercise training sessions. Outcomes include a standardized QOL questionnaire and objective tests of functional status (6-minute walk and activities of daily living performance).

Status:

Subject recruitment and interventions completed; data collection completed; currently analyzing data on effects of intervention on health care utilization and other parameters.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
  • Lung Diseases
  • Obstructive
Behavioral: Exercise Training
Arm 1
Intervention: Behavioral: Exercise Training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
December 2000
Not Provided

Inclusion Criteria:

COPD diagnosis; FEV,<_ 60% pred; FEV, /FVC< _85% pred

Exclusion Criteria:

Male
50 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00012792
IIR 96-015
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: David William Sparrow, DSc VA Boston Health Care System
Department of Veterans Affairs
April 2014

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