Randomized Controlled Trial of Exercise Training in Patients With COPD
Exercise Training
Lung Diseases
+ Respiratory Tract Diseases
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.130 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.From 50 to 79 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: COPD diagnosis; FEV,\<\_ 60% pred; FEV, /FVC\< \_85% pred Exclusion Criteria:
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, United StatesOpen VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA in Google Maps