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

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ClinicalTrials.gov Identifier: NCT02597985
Recruitment Status : Recruiting
First Posted : November 5, 2015
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Mandeep Singh, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Aortic Stenosis Other: Prehabilitation Other: Usual Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prehabilitation to Improve Functional and Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Replacement: TAVR-FRAILTY Trial
Study Start Date : October 2015
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Prehabilitation
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
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.

Placebo Comparator: Usual care
Will receive usual care
Other: Usual Care



Primary Outcome Measures :
  1. Change in Score on short physical performance battery (SPPB) test [ Time Frame: Baseline, approximately 1 year ]


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02597985


Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Mandeep Singh, MD, MPH    507-255-5891    singh.mandeep@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Mandeep Singh, MD Mayo Clinic

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Responsible Party: Mandeep Singh, Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02597985     History of Changes
Other Study ID Numbers: 15-004180
First Posted: November 5, 2015    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: October 2017

Keywords provided by Mandeep Singh, Mayo Clinic:
Frailty

Additional relevant MeSH terms:
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Aortic Valve Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction