Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012792
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2001-03-14
Brief Title:
Randomized Controlled Trial of Exercise Training in Patients With COPD
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Randomized Controlled Trial of Exercise Training in Patients With COPD
Status:
COMPLETED
Status Verified Date:
2005-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Chronic obstructive pulmonary disease COPD is one of the most common chronic illnesses in the adult population and accounts for approximately 25000 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 25000 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
Chronic obstructive pulmonary disease COPD is one of the most common chronic illnesses in the adult population and accounts for approximately 25000 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None