Lung Diseases Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
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