Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement (REHAB-TAVR)

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

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.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Behavioral: Exercise; Behavioral: Cognitive behavioral interventions; Behavioral: Attention control education program

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
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02120
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02131
      • Hebrew SeniorLife

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise & Cognitive Behavioral Int.; 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; 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.; Behavioral: Cognitive behavioral interventions; 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.
Experimental: Exercise Alone; 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; 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.
Active Comparator: Attention Control Education Program; Participants will receive telephone-based education sessions from a study health professional.	Behavioral: Attention control education program; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mini-Mental State Examination (MMSE) Score	MMSE is an instrument that assesses general cognitive function (range: 0 to 30). Higher scores indicate better cognitive function.	At baseline and week 8
Change in New York Heart Association (NYHA) Functional Class	NYHA assesses the extent of physical activity limitation due to heart failure. It ranges from 1 (ordinary physical activity does not cause symptoms) to 4 (symptoms occur at rest).	At baseline and week 8
Change in the Self-Efficacy Scale for Exercise (SEE)	The SEE scale measures self-efficacy about exercise (range: 0-90). Higher values indicate higher self efficacy.	At baseline and week 8
Change in the Outcome Expectation Scale for Exercise (OEE)	The OEE scale measures outcome expectation about exercise (range: 9-45). Higher scores indicate higher expectation.	At baseline and week 8
Adherence to the Home-based Exercise Program	The proportion of days with completed daily task during the entire study period will be measured.	At week 8

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Beth Israel Deaconess Medical Center; National Institute on Aging (NIA); Hebrew SeniorLife
• Investigators: Principal Investigator: Dae Hyun Kim, MD, MPH, ScD, Beth Israel Deaconess Medical Center

Publications and helpful links

General Publications

• Abraham 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:CD010876. doi: 10.1002/14651858.CD010876.pub3.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): May 6, 2020
• Study Completion (Actual): May 6, 2020

Study Registration Dates

• First Submitted: June 11, 2016
• First Submitted That Met QC Criteria: June 17, 2016
• First Posted (Estimate): June 20, 2016

Study Record Updates

• Last Update Posted (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: June 30, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Exercise; Transcatheter Aortic Valve Replacement; Frailty; Functional Outcomes; Cognitive Behavioral Intervention
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: 2017P000106; P30AG031679 (U.S. NIH Grant/Contract); P30AG048785 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No