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Randomized Controlled Trial of Exercise Training in Patients With COPD

Randomized Controlled Trial of Exercise Training in Patients With COPD

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00012792
Enrollment
130
Registered
2001-03-16
Start date
Unknown
Completion date
2000-12-31
Last updated
2015-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Diseases, Obstructive

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.

Interventions

BEHAVIORALExercise Training

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
50 Years to 79 Years
Healthy volunteers
No

Inclusion criteria

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026