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

Primary Purpose

Aortic Valve Stenosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Cognitive behavioral interventions
Attention control education program
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aortic Valve Stenosis focused on measuring Transcatheter Aortic Valve Replacement, Exercise, Frailty, Functional Outcomes, Cognitive Behavioral Intervention

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brigham and Women's Hospital
  • Hebrew SeniorLife
  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Exercise & Cognitive Behavioral Int.

Exercise Alone

Attention Control Education Program

Arm Description

A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program and cognitive behavioral interventions.

A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program, without cognitive behavioral interventions.

Participants will receive telephone-based education sessions from a study health professional.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Change in the 2-Minute Walk Distance (Feet)
The 2-minute walk distance measures endurance. A longer distance indicates better endurance.
Change in Dominant Hand Grip Strength (kg)
Dominant hand grip strength measures upper extremity strength.
Number of Participants Who Experienced Adverse Events
Number of participants who experience any adverse events and serious adverse events

Full Information

First Posted
June 11, 2016
Last Updated
June 30, 2021
Sponsor
Brigham and Women's Hospital
Collaborators
Hebrew SeniorLife, National Institute on Aging (NIA), Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02805309
Brief Title
Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement
Acronym
REHAB-TAVR
Official Title
Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
May 6, 2020 (Actual)
Study Completion Date
May 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Hebrew SeniorLife, National Institute on Aging (NIA), Beth Israel Deaconess Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis
Keywords
Transcatheter Aortic Valve Replacement, Exercise, Frailty, Functional Outcomes, Cognitive Behavioral Intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise & Cognitive Behavioral Int.
Arm Type
Experimental
Arm Description
A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program and cognitive behavioral interventions.
Arm Title
Exercise Alone
Arm Type
Experimental
Arm Description
A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program, without cognitive behavioral interventions.
Arm Title
Attention Control Education Program
Arm Type
Active Comparator
Arm Description
Participants will receive telephone-based education sessions from a study health professional.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral interventions
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Attention control education program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the Late-Life Function and Disability Instrument (LLFDI) Score
Description
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.
Time Frame
At baseline and week 8
Secondary Outcome Measure Information:
Title
Change in the Short Physical Performance Battery (SPPB) Summary Score
Description
The summary score is calculated based on chair stands, walking speed, and standing balance (range: 0-12). Higher scores indicate better physical performance.
Time Frame
At baseline and week 8
Title
Change in the 2-Minute Walk Distance (Feet)
Description
The 2-minute walk distance measures endurance. A longer distance indicates better endurance.
Time Frame
At baseline and week 8
Title
Change in Dominant Hand Grip Strength (kg)
Description
Dominant hand grip strength measures upper extremity strength.
Time Frame
At baseline and week 8
Title
Number of Participants Who Experienced Adverse Events
Description
Number of participants who experience any adverse events and serious adverse events
Time Frame
At week 8
Other Pre-specified Outcome Measures:
Title
Change in Mini-Mental State Examination (MMSE) Score
Description
MMSE is an instrument that assesses general cognitive function (range: 0 to 30). Higher scores indicate better cognitive function.
Time Frame
At baseline and week 8
Title
Change in New York Heart Association (NYHA) Functional Class
Description
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).
Time Frame
At baseline and week 8
Title
Change in the Self-Efficacy Scale for Exercise (SEE)
Description
The SEE scale measures self-efficacy about exercise (range: 0-90). Higher values indicate higher self efficacy.
Time Frame
At baseline and week 8
Title
Change in the Outcome Expectation Scale for Exercise (OEE)
Description
The OEE scale measures outcome expectation about exercise (range: 9-45). Higher scores indicate higher expectation.
Time Frame
At baseline and week 8
Title
Adherence to the Home-based Exercise Program
Description
The proportion of days with completed daily task during the entire study period will be measured.
Time Frame
At week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dae Hyun Kim, MD, MPH, ScD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02120
Country
United States
Facility Name
Hebrew SeniorLife
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33962483
Citation
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(5):CD010876. doi: 10.1002/14651858.CD010876.pub3.
Results Reference
derived

Learn more about this trial

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

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