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

• ClinicalTrials.gov Identifier: NCT02805309
• Recruitment Status: Completed
• First Posted: June 20, 2016
• Results First Posted: July 21, 2021
• Last Update Posted: July 21, 2021
• Sponsor: Brigham and Women's Hospital
• Collaborators: Hebrew SeniorLife; National Institute on Aging (NIA); Beth Israel Deaconess Medical Center
• Information provided by (Responsible Party): Dae Hyun Kim, MD, MPH, ScD, Brigham and Women's Hospital

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.

Condition or disease	Intervention/treatment	Phase
Aortic Valve Stenosis	Behavioral: Exercise; Behavioral: Cognitive behavioral interventions; Behavioral: Attention control education program	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement: A Pilot Study
• Actual Study Start Date: August 1, 2017
• Actual Primary Completion Date: May 6, 2020
• Actual Study Completion Date: May 6, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Change in the Late-Life Function and Disability Instrument (LLFDI) Score [ Time Frame: 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 :

1. Change in the Short Physical Performance Battery (SPPB) Summary Score [ Time Frame: 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.
2. Change in the 2-Minute Walk Distance (Feet) [ Time Frame: At baseline and week 8 ]
   The 2-minute walk distance measures endurance. A longer distance indicates better endurance.
3. Change in Dominant Hand Grip Strength (kg) [ Time Frame: At baseline and week 8 ]
   Dominant hand grip strength measures upper extremity strength.
4. Number of Participants Who Experienced Adverse Events [ Time Frame: At week 8 ]
   Number of participants who experience any adverse events and serious adverse events

Other Outcome Measures:

1. Change in Mini-Mental State Examination (MMSE) Score [ Time Frame: At baseline and week 8 ]
   MMSE is an instrument that assesses general cognitive function (range: 0 to 30). Higher scores indicate better cognitive function.
2. Change in New York Heart Association (NYHA) Functional Class [ Time Frame: At baseline and week 8 ]
   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).
3. Change in the Self-Efficacy Scale for Exercise (SEE) [ Time Frame: At baseline and week 8 ]
   The SEE scale measures self-efficacy about exercise (range: 0-90). Higher values indicate higher self efficacy.
4. Change in the Outcome Expectation Scale for Exercise (OEE) [ Time Frame: At baseline and week 8 ]
   The OEE scale measures outcome expectation about exercise (range: 9-45). Higher scores indicate higher expectation.
5. Adherence to the Home-based Exercise Program [ Time Frame: At week 8 ]
   The proportion of days with completed daily task during the entire study period will be measured.

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Massachusetts

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02120

Hebrew SeniorLife

Boston, Massachusetts, United States, 02131

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Brigham and Women's Hospital

Hebrew SeniorLife

National Institute on Aging (NIA)

Beth Israel Deaconess Medical Center

Investigators

• Principal Investigator: Dae Hyun Kim, MD, MPH, ScD; Beth Israel Deaconess Medical Center

  Study Documents (Full-Text)

Documents provided by Dae Hyun Kim, MD, MPH, ScD, Brigham and Women's Hospital:

Study Protocol and Statistical Analysis Plan  [PDF] March 9, 2021

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Dae Hyun Kim, MD, MPH, ScD, Associate Physician, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT02805309
• Other Study ID Numbers: 2017P000106; P30AG031679 ( U.S. NIH Grant/Contract ); P30AG048785 ( U.S. NIH Grant/Contract )
• First Posted: June 20, 2016
• Results First Posted: July 21, 2021
• Last Update Posted: July 21, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dae Hyun Kim, MD, MPH, ScD, Brigham and Women's Hospital:

Transcatheter Aortic Valve Replacement; Exercise; Frailty; Functional Outcomes; Cognitive Behavioral Intervention

Additional relevant MeSH terms:

Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction