N/A
Completed N=54
Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement
Source: ClinicalTrials.gov NCT02805309 ↗Enrolled (actual)
54
Serious AEs
7.8%
Results posted
Jul 2021
Primary outcomePrimary: Change in the Late-Life Function and Disability Instrument (LLFDI) Score — 53.2; 52.0; 52.9; 58.9 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Late-Life Function and Disability Instrument (LLFDI) Score |
53.2; 52.0; 52.9; 58.9; 43; 54.4 | — |
| SECONDARY Change in the Short Physical Performance Battery (SPPB) Summary Score |
5.9; 4.5; 5.3; 9.7; 9.3; 6.5 | — |
| SECONDARY Change in the 2-Minute Walk Distance (Feet) |
313.9; 279.0; 244.6; 333.0; 357.4; 282.8 | — |
| SECONDARY Change in Dominant Hand Grip Strength (kg) |
21.8; 23.7; 19.5; 23.0; 22.8; 24.1 | — |
| SECONDARY Number of Participants Who Experienced Adverse Events |
12; 8; 8; 1; 2; 1 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02805309). 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. Informational only — not medical advice.