Clinical trial NCT00467298: An Intervention to Improve Function in Severe Cardiopulmonary Illness
Official title: An Intervention to Enhance Function in Severe Cardiopulmonary Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Heart Failure
Keywords: Exercise
heart failure
chronic obstructive pulmonary disease
patient education
costs
quality of life
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2007-04-30
Enrollment: 90
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Function Capability
timeFrame: 6 months
Secondary outcomes:
measure: Quality of Life
timeFrame: 6 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Health Care System
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System
name: Bonnie G. Steele, PhD RN
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Puget Sound Health Care System, Seattle
name: Cynthia M. Dougherty, PhD RN
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.