Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement
- Conditions
- Aortic Valve Stenosis
- Registration Number
- NCT02805309
- Lead Sponsor
- Brigham and Women's Hospital
- Brief Summary
Transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure for older adults with severe symptomatic aortic stenosis who are considered high risk for surgical aortic valve replacement. Despite symptomatic and survival benefits, many patients experience functional decline after TAVR. This pilot study aims to test the feasibility of a home-based exercise intervention targeting endurance, strength, and balance as well as cognitive behavioral intervention to improve physical functioning and disability after TAVR.
- Detailed Description
We hypothesize that a home-based exercise program with cognitive behavioral intervention is more effective than home-based exercise alone; home-based exercise program with and without cognitive behavioral intervention is more effective than attention control educational intervention in preventing decline in physical function and disability after TAVR.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
- Age ≥ 65 years
- Underwent transcatheter aortic valve replacement
- Lives within 20-mile radius of the recruiting site
- Plan to be discharged home
- Able to provide informed consent
- Stroke or any other medical disease that precludes participation in the exercise program
- Severe cognitive impairment (Mini-Mental State Examination < 15)
- Current enrollment in another clinical trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in the Late-Life Function and Disability Instrument (LLFDI) Score At baseline and week 8 The LLFDI is a validated patient-reported outcome questionnaire that measures both functional limitations (inability to perform physical tasks - Activity Limitation Domain score, range: 0-100) and disability (inability to perform major life tasks and social roles - Participation Restriction Domain score, range: 0-100). For both scales, higher values indicate better function (lower limitation or lower disability). Two domain scores are analyzed separately.
- Secondary Outcome Measures
Name Time Method Change in the Short Physical Performance Battery (SPPB) Summary Score At baseline and week 8 The summary score is calculated based on chair stands, walking speed, and standing balance (range: 0-12). Higher scores indicate better physical performance.
Number of Participants Who Experienced Adverse Events At week 8 Number of participants who experience any adverse events and serious adverse events
Change in Dominant Hand Grip Strength (kg) At baseline and week 8 Dominant hand grip strength measures upper extremity strength.
Change in the 2-Minute Walk Distance (Feet) At baseline and week 8 The 2-minute walk distance measures endurance. A longer distance indicates better endurance.
Trial Locations
- Locations (3)
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Hebrew SeniorLife
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Brigham and Women's Hospital🇺🇸Boston, Massachusetts, United States