Prehabilitation to Improve Functional and Clinical Outcomes in Patients With Aortic Stenosis (TAVR-FRAILTY)

Mayo Clinic

Status: Completed

Conditions: Aortic Stenosis

Treatments: Other: Prehabilitation; Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT02597985

15-004180

Details and patient eligibility

About

Transcatheter aortic valve replacement (TAVR) is a treatment alternative among high-risk elderly with aortic stenosis, however, mortality remains high. Fifty percent of patients undergoing TAVR exhibit frailty, a syndrome associated with poor survival. It is unknown whether interventions to improve frailty before TAVR (prehabilitation) will improve outcomes after TAVR. This study plans to evaluate whether simple cardiac exercise interventions to improve physical performance before TAVR improves outcomes after TAVR.

Enrollment: 13 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Eligibility for TAVR
• SPPB<9
• Able to exercise
• Able to come for follow-up visits
• Able to give informed consent

Exclusion criteria

• New York Heart Association (NYHA) Class III/IV congestive heart failure (CHF)
• Presyncope or syncope as presentation
• Acute coronary syndrome
• Unable to exercise
• Dementia
• Sustained ventricular arrhythmia
• Stroke with neurological deficit
• Advanced Parkinson's
• Participated in an exercise program

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups, including a placebo group

Prehabilitation

Active Comparator group

Description:

Will receive 4 weeks of supervised exercised prescription before they undergo TAVR and will monitor and record, improvement if any, in the short-term physical performance battery score

Treatment:

Other: Prehabilitation

Usual care

Placebo Comparator group

Description:

Will receive usual care

Treatment:

Other: Usual Care