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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00467298 |
The study proposes 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.
Condition | Intervention |
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Chronic Obstructive Pulmonary Disease (COPD) Heart Failure |
Behavioral: Exercise adherence Behavioral: Self-management- prevention of illness Behavioral: Self-management of illness |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | An Intervention to Enhance Function in Severe Cardiopulmonary Illness |
Estimated Enrollment: | 200 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | September 2011 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Novel intensive self-management education and exercise program of four weeks
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Behavioral: Exercise adherence
The exercise program includes endurance and strength training and warm-up and cool-down strategies. Emphasis is placed upon implementing and adhering to the exercise program at home following intervention completion.
Behavioral: Self-management- prevention of illness
Instruction is provided regarding key elements of managing heart failure and COPD with emphasis upon individual adaptations to prevent exacerbations, unscheduled provider visits, and hospital admissions as well as promotion of daily activity.
Behavioral: Self-management of illness
This component of the intervention stresses the use of an action plan that is implemented to c-manage bouts of mild illness and to identify symptoms of more serious illness, including appropriate actions.
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2: No Intervention
Usual care- cardiac or pulmonary rehabilitation exercise program of 8 weeks duration
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This study proposes 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 qalk 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.
Ages Eligible for Study: | 45 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Bonnie G Steele, PhD RN | (206) 764-2496 | bonnie.steele@va.gov |
Contact: Cynthia M Dougherty, PhD RN | (206) 764-2205 | cynthia.dougherty@va.gov |
United States, Washington | |
VA Puget Sound Health Care System | Recruiting |
Seattle, Washington, United States, 98101 | |
Contact: Bonnie G Steele, PhD RN 206-764-2496 bonnie.steele@va.gov | |
Contact: Cynthia M Dougherty, PhD RN (206) 764-2205 cynthia.dougherty@va.gov | |
Sub-Investigator: Michael K. Chapko, PhD | |
Principal Investigator: Bonnie G. Steele, PhD RN | |
Sub-Investigator: Cynthia M. Dougherty, PhD RN |
Principal Investigator: | Bonnie G. Steele, PhD RN | VA Puget Sound Health Care System |
Responsible Party: | Department of Veterans Affairs ( Steele, Bonnie - Principal Investigator ) |
Study ID Numbers: | NRI 04-242 |
Study First Received: | April 25, 2007 |
Last Updated: | September 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00467298 |
Health Authority: | United States: Federal Government |
Exercise heart failure chronic obstructive pulmonary disease |
patient education costs quality of life |
Heart Failure Lung Diseases, Obstructive Heart Diseases Respiratory Tract Diseases |
Lung Diseases Respiration Disorders Quality of Life Pulmonary Disease, Chronic Obstructive |
Cardiovascular Diseases |