CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 64 enrolled
Drug / intervention
Exercise +2 morebehavioral
Likely dose
Not stated in record
Key inclusion· 5
  • Age 65 years or older
  • Underwent transcatheter aortic valve replacement
  • Lives within 20-mile radius of recruiting site
  • Plan to be discharged home
Key exclusion· 3
  • History of stroke or other medical disease that precludes exercise participation
  • Severe cognitive impairment (Mini-Mental State Examination < 15)
  • Current enrollment in another clinical trial

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02805309
NCT02805309N/ACompleted

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

Brigham and Women's Hospital·interventional·Posted Jun 20, 2016·Updated Jul 21, 2021

In Brief

A clinical study evaluating Exercise, Cognitive behavioral interventions, and 1 other intervention for Aortic Valve Stenosis. Completed, enrolled 64 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJun 20, 2016
Enrollment StartAug 1, 2017
Primary CompletionMay 6, 2020
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 10.0 years ago

Interventions

Exercisebehavioral

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 interventionsbehavioral

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 programbehavioral

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.