An Intervention to Improve Function in Severe Cardiopulmonary Illness

Not Applicable

Completed

Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Heart Failure

Interventions: Behavioral: Exercise adherence
Behavioral: Self-management- prevention of illness
Behavioral: Self-management of illness

Registration Number: NCT00467298

Lead Sponsor: VA Office of Research and Development

Brief Summary: The study is a randomized trial of a cardiopulmonary self-management intervention to improve functional capacity, health-related quality of life, and to reduce health care utilization. Two hundred (100 in each group) will be recruited from VA Puget Sound Health Care System over four years. Outcomes will be measured at three points: at entry, at the end of the 6 month intervention, and 12 months after entry. Change in functional capacity at the end of the intervention program is the primary outcome.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 90

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-management	Self-management of illness	Novel intensive self-management education and exercise program of four weeks
Self-management	Exercise adherence	Novel intensive self-management education and exercise program of four weeks
Self-management	Self-management- prevention of illness	Novel intensive self-management education and exercise program of four weeks

Primary Outcome Measures

Name	Time	Method
Function Capability	6 months	6MWT-Six Minute Walk Test

Secondary Outcome Measures

Name	Time	Method
Quality of Life	6 months	SF-36 PCS. Scale range 0-100, higher scores reflect higher quality of life. PCS=Physical Composite Score. These are not change scores.