An Intervention to Improve Function in Severe Cardiopulmonary Illness

This study is a randomized, controlled trial of a cardiopulmonary exercise and
self-management intervention to improve functional capacity, health related-related quality
of life, and to reduce health care costs in medically fragile, elderly patients with chronic
obstructive pulmonary disease (COPD) or heart failure (HF). Specific aims include: (1) To
determine the benefits of a combined outpatient/home-based exercise, self-management program
on function al capability (daily activity, six-minute walk distance, symptoms), (2) to
determine the effects of exercise/self-management on quality of life, health status,
cardiopulmonary function, and gait and balance, (3) to test the theoretical self-regulation
model for mediating effects on major outcome variables, and (4) to compare health care
resource utilization and expenditures between the intervention and usual care groups in order
to conduct a cost-effectiveness analysis of the program. The primary outcome upon which the
study is powered is functional capability measured by daily physical activity. Outcomes will
be measured at three time points: at entry and following the intervention at 6 and 12 months.
Two-hundred (100/group) will be recruited from the VA Puget Sound Health Care System
outpatient clinics. The study will be carried out over four years. Inclusion criteria include
standard criteria for severe COPD or HF, optimal medical management, willingness to
participate in an outpatient exercise/self-management program, working phone, hospitalization
for HF, COPD, or related illness in the past two years or at least two outpatient visits for
same over the past year. Exclusion criteria include unstable disease or recent surgery,
supplemental oxygen requirement at rest more than 4 LPM, already participating in regular
exercise three times a week, inability to ambulate, uncontrolled mental illness, alcohol or
drug abuse and life expectancy less than one year. The intervention consists of a month long
program of two 2-hour visits a week incorporating equal time for endurance and strength
training as well as individually-tailored instruction in self-management of their heart/lung
disease. Usual care control is an 8-week standard cardiopulmonary exercise program, two days
a week for an hour with some self-management content.

Inclusion Criteria:

- standard criteria for severe COPD or HF,

- optimal medical management,

- willingness to participate in an outpatient exercise/self-management program,

- working phone,

- hospitalization for HF, COPD, or related illness in the past two years or at least two
unscheduled outpatient visits for same over the past year

Exclusion Criteria:

- unstable disease or recent surgery,

- supplemental oxygen requirement at rest more than 4 LPM,

- already participating in regular exercise three times a week,

- inability to ambulate,

- uncontrolled mental illness,

- alcohol or drug abuse,

- life expectancy less than one year