An Intervention to Improve Function in Severe Cardiopulmonary Illness
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD), Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise adherence
Self-management- prevention of illness
Self-management of illness
Sponsored by
About this trial
This is an interventional other trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Exercise, heart failure, chronic obstructive pulmonary disease, patient education, costs, quality of life
Eligibility Criteria
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
Sites / Locations
- VA Puget Sound Health Care System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Self-management
Usual care
Arm Description
Novel intensive self-management education and exercise program of four weeks
Usual care- cardiac or pulmonary rehabilitation exercise program of 8 weeks duration
Outcomes
Primary Outcome Measures
Function Capability
6MWT-Six Minute Walk Test
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00467298
First Posted
April 25, 2007
Last Updated
August 30, 2017
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT00467298
Brief Title
An Intervention to Improve Function in Severe Cardiopulmonary Illness
Official Title
An Intervention to Enhance Function in Severe Cardiopulmonary Illness
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD), Heart Failure
Keywords
Exercise, heart failure, chronic obstructive pulmonary disease, patient education, costs, quality of life
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Self-management
Arm Type
Experimental
Arm Description
Novel intensive self-management education and exercise program of four weeks
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual care- cardiac or pulmonary rehabilitation exercise program of 8 weeks duration
Intervention Type
Behavioral
Intervention Name(s)
Exercise adherence
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Self-management- prevention of illness
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Self-management of illness
Intervention Description
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.
Primary Outcome Measure Information:
Title
Function Capability
Description
6MWT-Six Minute Walk Test
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Quality of Life
Description
SF-36 PCS. Scale range 0-100, higher scores reflect higher quality of life. PCS=Physical Composite Score. These are not change scores.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bonnie G. Steele, PhD RN
Organizational Affiliation
VA Puget Sound Health Care System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cynthia M. Dougherty, PhD RN
Organizational Affiliation
VA Puget Sound Health Care System, Seattle
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Puget Sound Health Care System
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18295615
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
20068424
Citation
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.
Results Reference
background
PubMed Identifier
19750190
Citation
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.
Results Reference
result
PubMed Identifier
20861749
Citation
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.
Results Reference
result
PubMed Identifier
22772084
Citation
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.
Results Reference
derived
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An Intervention to Improve Function in Severe Cardiopulmonary Illness
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