Randomized Controlled Trial of Exercise Training in Patients With COPD
Condition: Lung Diseases; Obstructive
MeSH terms: Lung Diseases
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Exercise Training
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)