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

Aortic Valve Stenosis Clinical Trial

— REHAB-TAVR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02805309
• Other study ID #: 2017P000106
• Secondary ID: P30AG031679P30AG
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: May 6, 2020

Study information

• Verified date: June 2021
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: May 6, 2020
• Est. primary completion date: May 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Hebrew SeniorLife	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Beth Israel Deaconess Medical Center, Hebrew SeniorLife, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	Change in Dominant Hand Grip Strength (kg)	Dominant hand grip strength measures upper extremity strength.	At baseline and week 8
Secondary	Number of Participants Who Experienced Adverse Events	Number of participants who experience any adverse events and serious adverse events	At week 8