N/A
N=90
An Intervention to Improve Function in Severe Cardiopulmonary Illness
Chronic Obstructive Pulmonary Disease (COPD) · Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT00467298 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcome: Primary: Function Capability — 349; 338 meters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Exercise adherence (Behavioral); Self-management- prevention of illness (Behavioral); Self-management of illness (Behavioral)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Function Capability |
349; 338 | — |
| SECONDARY Quality of Life |
31; 38 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00467298). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.