Clinical trial NCT00012792: Randomized Controlled Trial of Exercise Training in Patients With COPD
Official title: Randomized Controlled Trial of Exercise Training in Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lung Diseases
Obstructive
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-03-16
Enrollment: 130
Sex: MALE
Minimum age (years): 50
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
state: Massachusetts
Study officials:
affiliation: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
name: David William Sparrow, DSc
role: PRINCIPAL_INVESTIGATOR
References: