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

Mass General Brigham

Status: Completed

Conditions: Aortic Valve Stenosis

Treatments: Behavioral: Attention control education program; Behavioral: Cognitive behavioral interventions; Behavioral: Exercise

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02805309

2017P000106

P30AG048785 (U.S. NIH Grant/Contract)

P30AG031679 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 65+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

64 participants in 3 patient groups

Exercise & Cognitive Behavioral Int.

Experimental group

Description:

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

Treatment:

Behavioral: Cognitive behavioral interventions

Behavioral: Exercise

Exercise Alone

Experimental group

Description:

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

Treatment:

Behavioral: Exercise

Attention Control Education Program

Active Comparator group

Description:

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

Treatment:

Behavioral: Attention control education program