Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement
REHAB-TAVR
3 other identifiers
interventional
64
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2017
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2016
CompletedFirst Posted
Study publicly available on registry
June 20, 2016
CompletedStudy Start
First participant enrolled
August 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 6, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 6, 2020
CompletedResults Posted
Study results publicly available
July 21, 2021
CompletedJuly 21, 2021
June 1, 2021
2.8 years
June 11, 2016
June 4, 2021
June 30, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Change in the Short Physical Performance Battery (SPPB) Summary Score
At baseline and week 8
Change in the 2-Minute Walk Distance (Feet)
At baseline and week 8
Change in Dominant Hand Grip Strength (kg)
At baseline and week 8
Number of Participants Who Experienced Adverse Events
At week 8
Other Outcomes (5)
Change in Mini-Mental State Examination (MMSE) Score
At baseline and week 8
Change in New York Heart Association (NYHA) Functional Class
At baseline and week 8
Change in the Self-Efficacy Scale for Exercise (SEE)
At baseline and week 8
- +2 more other outcomes
Study Arms (3)
Exercise & Cognitive Behavioral Int.
EXPERIMENTALA physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program and cognitive behavioral interventions.
Exercise Alone
EXPERIMENTALA 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
ACTIVE COMPARATORParticipants will receive telephone-based education sessions from a study health professional.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brigham and Women's Hospitallead
- Hebrew SeniorLifecollaborator
- National Institute on Aging (NIA)collaborator
- Beth Israel Deaconess Medical Centercollaborator
Study Sites (3)
Brigham and Women's Hospital
Boston, Massachusetts, 02120, United States
Hebrew SeniorLife
Boston, Massachusetts, 02131, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Related Publications (2)
Shi SM, Rapley FA, Margulis H, Laham RJ, Guibone K, Percy E, Kaneko T, Wang KY, Kim DH. Home-Based Rehabilitation After Transcatheter Aortic Valve Replacement (REHAB-TAVR): A Pilot Randomized Controlled Trial. J Am Geriatr Soc. 2025 Jun;73(6):1836-1846. doi: 10.1111/jgs.19456. Epub 2025 Apr 2.
PMID: 40171799DERIVEDAbraham LN, Sibilitz KL, Berg SK, Tang LH, Risom SS, Lindschou J, Taylor RS, Borregaard B, Zwisler AD. Exercise-based cardiac rehabilitation for adults after heart valve surgery. Cochrane Database Syst Rev. 2021 May 7;5(5):CD010876. doi: 10.1002/14651858.CD010876.pub3.
PMID: 33962483DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The primary outcome measure instrument, LLFDI Computer Adaptive Test software for Windows, could not be run after Windows operating system update during the study period. The software was not maintained by the developer to keep up with the latest version of the operating system. As a result, LLFDI measure was not measured for most participants at 8 weeks. The investigators measured a disability score (22 daily activities and physical tasks), which is highly correlated with LLFDI scores.
Results Point of Contact
- Title
- Dr. Dae Hyun Kim, Associate Scientist
- Organization
- Hebrew SeniorLife Marcus Institute for Aging Research
Study Officials
- PRINCIPAL INVESTIGATOR
Dae Hyun Kim, MD, MPH, ScD
Beth Israel Deaconess Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Physician
Study Record Dates
First Submitted
June 11, 2016
First Posted
June 20, 2016
Study Start
August 1, 2017
Primary Completion
May 6, 2020
Study Completion
May 6, 2020
Last Updated
July 21, 2021
Results First Posted
July 21, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share