Prehabilitation to Improve Functional and Clinical Outcomes in Patients With Aortic Stenosis (TAVR-FRAILTY)
Primary Purpose
Aortic Stenosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prehabilitation
Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Stenosis focused on measuring Frailty
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Prehabilitation
Usual care
Arm 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
Will receive usual care
Outcomes
Primary Outcome Measures
Change in Score on short physical performance battery (SPPB) test
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02597985
Brief Title
Prehabilitation to Improve Functional and Clinical Outcomes in Patients With Aortic Stenosis
Acronym
TAVR-FRAILTY
Official Title
Prehabilitation to Improve Functional and Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Replacement: TAVR-FRAILTY Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
June 17, 2019 (Actual)
Study Completion Date
September 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis
Keywords
Frailty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prehabilitation
Arm Type
Active Comparator
Arm 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
Arm Title
Usual care
Arm Type
Placebo Comparator
Arm Description
Will receive usual care
Intervention Type
Other
Intervention Name(s)
Prehabilitation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care
Primary Outcome Measure Information:
Title
Change in Score on short physical performance battery (SPPB) test
Time Frame
Baseline, approximately 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mandeep Singh, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Prehabilitation to Improve Functional and Clinical Outcomes in Patients With Aortic Stenosis
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