Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00467298
Status:
COMPLETED
Last Update Posted:
2018-04-02
First Post:
2007-04-25
Brief Title:
An Intervention to Improve Function in Severe Cardiopulmonary Illness
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
An Intervention to Enhance Function in Severe Cardiopulmonary Illness
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 outpatienthome-based exercise self-management program on function al capability daily activity six-minute walk distance symptoms 2 to determine the effects of exerciseself-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 100group 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 exerciseself-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 heartlung disease Usual care control is an 8-week standard cardiopulmonary exercise program two days a week for an hour with some self-management content
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None