Clinical trial NCT02805309: Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement
Official title: Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
Keywords: Transcatheter Aortic Valve Replacement
Exercise
Frailty
Functional Outcomes
Cognitive Behavioral Intervention
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Hebrew SeniorLife
name: National Institute on Aging (NIA)
name: Beth Israel Deaconess Medical Center
First posted: 2016-06-20
Enrollment: 64
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in the Late-Life Function and Disability Instrument (LLFDI) Score
timeFrame: At baseline and week 8
Secondary outcomes:
measure: Change in the Short Physical Performance Battery (SPPB) Summary Score
timeFrame: At baseline and week 8
measure: Change in the 2-Minute Walk Distance (Feet)
timeFrame: At baseline and week 8
measure: Change in Dominant Hand Grip Strength (kg)
timeFrame: At baseline and week 8
measure: Number of Participants Who Experienced Adverse Events
timeFrame: At week 8
Other outcomes:
measure: Change in Mini-Mental State Examination (MMSE) Score
timeFrame: At baseline and week 8
measure: Change in New York Heart Association (NYHA) Functional Class
timeFrame: At baseline and week 8
measure: Change in the Self-Efficacy Scale for Exercise (SEE)
timeFrame: At baseline and week 8
measure: Change in the Outcome Expectation Scale for Exercise (OEE)
timeFrame: At baseline and week 8
measure: Adherence to the Home-based Exercise Program
timeFrame: At week 8
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Hebrew SeniorLife
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Dae Hyun Kim, MD, MPH, ScD
role: PRINCIPAL_INVESTIGATOR
References:
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.