NCT Number: NCT02805309
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.
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Notify Me65 year and older
All sexes
Interventional
Not applicable
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
Time frame: At baseline and week 8
The 2-minute walk distance measures endurance. A longer distance indicates better endurance.
Time frame: At baseline and week 8
Dominant hand grip strength measures upper extremity strength.
Time frame: At week 8
Number of participants who experience any adverse events and serious adverse events
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.
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).
Time frame: At baseline and week 8
The SEE scale measures self-efficacy about exercise (range: 0-90). Higher values indicate higher self efficacy.
Time frame: At baseline and week 8
The OEE scale measures outcome expectation about exercise (range: 9-45). Higher scores indicate higher expectation.
Time frame: At week 8
The proportion of days with completed daily task during the entire study period will be measured.
Brigham and Women's Hospital
Other
Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement: A Pilot Study
Acronym: REHAB-TAVR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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