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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement: A Pilot Study

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Behavioral: Exercise
* Behavioral: Cognitive behavioral interventions
* Behavioral: Attention control education program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise & Cognitive Behavioral Int.<br>A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program and cognitive behavioral interventions. | Behavioral: Exercise<br>* Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins.<br>Behavioral: Cognitive behavioral interventions<br>* The following cognitive-behavioral strategies will be employed: 1) enhance positive beliefs about exercise through discussion of benefits of exercise; 2) discussion of barriers to exercise; 3) individualized goal setting and self-monitoring progress using exercise calendar; 4) develop a detailed exercise plan on how, what, when, and where to conduct exercise; 5) $10 rewards for exercising ≥30 mins per day for ≥5 of 7 days. The duration of this intervention is about 20 mins.<br>|
| Experimental: Exercise Alone<br>A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program, without cognitive behavioral interventions. | Behavioral: Exercise<br>* Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins.<br>|
| Active Comparator: Attention Control Education Program<br>Participants will receive telephone-based education sessions from a study health professional. | Behavioral: Attention control education program<br>* A health care professional will call the participant weekly for a period of 8 weeks to teach general tips about exercise and diet (source: https://go4life.nia.nih.gov/). No recommendations for a specific exercise program will be made, except for walking 30 minutes daily or as tolerated. Each telephone session will cover 4 exercise tips and 4 healthy eating tips. The duration of the intervention is about 30 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Late-Life Function and Disability Instrument (LLFDI) Score | 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. | At baseline and week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Short Physical Performance Battery (SPPB) Summary Score | The summary score is calculated based on chair stands, walking speed, and standing balance (range: 0-12). Higher scores indicate better physical performance. | At baseline and week 8 | 
| Change in the 2-Minute Walk Distance (Feet) | The 2-minute walk distance measures endurance. A longer distance indicates better endurance. | At baseline and week 8 | 
| Change in Dominant Hand Grip Strength (kg) | Dominant hand grip strength measures upper extremity strength. | At baseline and week 8 | 
| Number of Participants Who Experienced Adverse Events | Number of participants who experience any adverse events and serious adverse events | At week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Transcatheter Aortic Valve Replacement, Frailty, Functional Outcomes, Cognitive Behavioral Intervention