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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-management | Experimental | Novel intensive self-management education and exercise program of four weeks |
|
| Usual care | No Intervention | Usual care- cardiac or pulmonary rehabilitation exercise program of 8 weeks duration |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise adherence | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Function Capability | 6MWT-Six Minute Walk Test | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | SF-36 PCS. Scale range 0-100, higher scores reflect higher quality of life. PCS=Physical Composite Score. These are not change scores. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bonnie G. Steele, PhD RN | VA Puget Sound Health Care System | Principal Investigator |
| Cynthia M. Dougherty, PhD RN | VA Puget Sound Health Care System, Seattle | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Puget Sound Health Care System | Seattle | Washington | 98101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18295615 | Background | Steele BG, Belza B, Cain KC, Coppersmith J, Lakshminarayan S, Howard J, Haselkorn JK. A randomized clinical trial of an activity and exercise adherence intervention in chronic pulmonary disease. Arch Phys Med Rehabil. 2008 Mar;89(3):404-12. doi: 10.1016/j.apmr.2007.11.003. | |
| Background | Steele BG, Cain K, Coppersmith J, Belza B, Howard J, Lakshminarayan S. Pulmonary rehabilitation (PR) outcomes in chronic obstructive pulmonary disease (COPD): Are benefits equivalent in end-stage disease? Proceedings of the American Thoracic Society. 2008 May 17; 177:A446. | ||
| 20068424 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Self-management | Novel intensive self-management education and exercise program of four weeks 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. 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. 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. |
| FG001 | Usual Care | Usual care- cardiac or pulmonary rehabilitation exercise program of 8 weeks duration |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Self-management | Novel intensive self-management education and exercise program of four weeks 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. 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Function Capability | 6MWT-Six Minute Walk Test | Posted | Mean | Standard Deviation | meters | 6 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Self-management | Novel intensive self-management education and exercise program of four weeks 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. 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. 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cynthia M. Dougherty | VA Puget Sound Health Care System-Seattle | 206 764 2205 | cynthia.dougherty@va.gov |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D006333 | Heart Failure |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Self-management- prevention of illness | Behavioral | 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. |
|
| Self-management of illness | Behavioral | 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. |
|
| Background |
| Steele BG, Belza B, Cain K, Coppersmith J, Howard J, Lakshminarayan S, Haselkorn J. The impact of chronic obstructive pulmonary disease exacerbation on pulmonary rehabilitation participation and functional outcomes. J Cardiopulm Rehabil Prev. 2010 Jan-Feb;30(1):53-60. doi: 10.1097/HCR.0b013e3181c85845. |
| 19750190 | Result | Nguyen HQ, Gill DP, Wolpin S, Steele BG, Benditt JO. Pilot study of a cell phone-based exercise persistence intervention post-rehabilitation for COPD. Int J Chron Obstruct Pulmon Dis. 2009;4:301-13. doi: 10.2147/copd.s6643. Epub 2009 Sep 1. |
| 20861749 | Result | Dougherty CM, Steele BG, Hunziker J. Testing an intervention to improve functional capability in advanced cardiopulmonary illness. J Cardiopulm Rehabil Prev. 2011 Jan-Feb;31(1):35-41. doi: 10.1097/HCR.0b013e3181f1fd77. |
| 22772084 | Derived | Nguyen HQ, Steele BG, Dougherty CM, Burr RL. Physical activity patterns of patients with cardiopulmonary illnesses. Arch Phys Med Rehabil. 2012 Dec;93(12):2360-6. doi: 10.1016/j.apmr.2012.06.022. Epub 2012 Jul 5. |
| BG001 | Usual Care | Usual care- cardiac or pulmonary rehabilitation exercise program of 8 weeks duration |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Usual Care | Usual care- cardiac or pulmonary rehabilitation exercise program of 8 weeks duration |
|
|
| Secondary | Quality of Life | SF-36 PCS. Scale range 0-100, higher scores reflect higher quality of life. PCS=Physical Composite Score. These are not change scores. | These are not change scores. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
| 0 |
| 46 |
| 0 |
| 46 |
| EG001 | Usual Care | Usual care- cardiac or pulmonary rehabilitation exercise program of 8 weeks duration | 0 | 44 | 0 | 44 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |