Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement

Not Applicable

Completed

Interventions: Behavioral: Exercise
Behavioral: Attention control education program
Behavioral: Cognitive behavioral interventions

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

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Exercise & Cognitive Behavioral Int.	Exercise	A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program and cognitive behavioral interventions.
Exercise & Cognitive Behavioral Int.	Cognitive behavioral interventions	A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program and cognitive behavioral interventions.
Exercise Alone	Exercise	A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program, without cognitive behavioral interventions.
Attention Control Education Program	Attention control education program	Participants will receive telephone-based education sessions from a study health professional.

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.

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