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NCT02597985 Clinical Trial

Prehabilitation to Improve Functional and Clinical Outcomes in Patients With Aortic Stenosis

Aortic Stenosis Clinical Trial

— TAVR-FRAILTY  

Official title:
Prehabilitation to Improve Functional and Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Replacement: TAVR-FRAILTY Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02597985
Other study ID # 15-004180
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2015
Est. completion date September 10, 2019

Study information
Verified date December 2021
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 13
Est. completion date September 10, 2019
Est. primary completion date June 17, 2019
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Prehabilitation
Supervised exercise training intervention will include three sessions per week for four weeks at a Mayo Clinic system cardiac rehabilitation facility. The Rochester, Minnesota Cardiac Rehabilitation Program will provide guidance and oversight. Modes of aerobic exercise will include treadmill walking (the primary mode of training) supplemented with non-weight-bearing activities such as stationary cycling and combination arm/leg recumbent exercise (NuStep device), as needed. Intensity will be set using Borg Perceived Exertion Scale (RPE) ratings of 12-14 (somewhat hard), keeping patients below the threshold for more than mild angina.
• Usual Care

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Score on short physical performance battery (SPPB) test Baseline, approximately 1 year
See also
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Terminated NCT00535899 - Speckle Tracking Imaging in Patients With Low Ejection Fraction Aortic Stenosis (SPArKLE-AS) N/A
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Completed NCT03314857 - China XT: Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese Population N/A
Completed NCT04157920 - Impact of Predilatation Between Self-expanding Valves N/A
Enrolling by invitation NCT06212050 - Feasibility, Safety, and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis
Recruiting NCT05893082 - Multicenter Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR N/A

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