Brief Title
Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement
Official Title
Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement: A Pilot Study
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.
Study Type
Interventional
Primary Outcome
Change in the Late-Life Function and Disability Instrument (LLFDI) Score
Secondary Outcome
Change in the Short Physical Performance Battery (SPPB) Summary Score
Condition
Aortic Valve Stenosis
Intervention
Exercise
Study Arms / Comparison Groups
Exercise & Cognitive Behavioral Int.
Description: A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program and cognitive behavioral interventions.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
61
Start Date
August 1, 2017
Completion Date
May 6, 2020
Primary Completion Date
May 6, 2020
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
Gender
All
Ages
65 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Dae Hyun Kim, MD, MPH, ScD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02805309
Organization ID
2017P000106
Secondary IDs
P30AG031679
Responsible Party
Principal Investigator
Study Sponsor
Brigham and Women's Hospital
Collaborators
Hebrew SeniorLife
Study Sponsor
Dae Hyun Kim, MD, MPH, ScD, Principal Investigator, Beth Israel Deaconess Medical Center
Verification Date
July 2020