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Prehabilitation for Patients Undergoing Transcatheter Aortic Valve Replacement (TAVR-Prehab)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03107897
Recruitment Status : Recruiting
First Posted : April 11, 2017
Last Update Posted : June 10, 2019
Sponsor:
Collaborator:
Lancaster General Hospital
Information provided by (Responsible Party):
James Harvey, WellSpan Health

Brief Summary:

In this pilot study, investigators aim to identify patients undergoing TAVR who are at elevated risk for adverse clinical events due to decreased exertional capacity and physical deconditioning. Investigators aim to determine if monitored pre-procedural physical therapy is safe in these patients. Lastly, investigators aim to assess the efficacy of prehabilitation

  1. to improve physical functioning by the time of TAVR and to sustain benefit through 30 days post-procedure; and
  2. to determine its effect on post-procedural length-of-stay, clinical outcomes, and quality of life.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Other: Pre-habilitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Comparing individuals who have prehabilitation prior to their TAVR procedure with those that do not.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prehabilitation for Patients Undergoing Transcatheter Aortic Valve Replacement
Actual Study Start Date : August 17, 2016
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : May 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Pre-procedure standard of care
No prehab prior to TAVR.
Active Comparator: Prehab prior to TAVR procedure.
Individuals participate in prehabilitation prior to TAVR.
Other: Pre-habilitation
Eight - Twelve visits to physical therapy prior to their TAVR procedure.




Primary Outcome Measures :
  1. Functional exercise capacity - Change in 6 Minute Walk Test (6MWT) [ Time Frame: One month post procedure ]
    Measure: Does prehabilitation improve the subject's functional exercise capacity from first PT assessment to pre-procedure assessment and first PT assessment to one month post-procedure, as measured by the 6MWT?


Secondary Outcome Measures :
  1. Mobility - Timed Up and Go Test [ Time Frame: One month ]
    Does prehabilitation improve the subject's mobility from first PT assessment to pre-procedure assessment and first PT assessment to one month post-procedure, as measured by the TUG test?

  2. Four Square Step Test [ Time Frame: One month ]
    Does prehabilitation improve the subject's balance from first PT assessment to preprocedure assessment and first PT assessment to one month post-procedure, as measured by the FSST?

  3. Change in Quality of Life (Kansas City Cardiomyopathy Questionnaire score) [ Time Frame: One month ]
    Does the Kansas City Cardiomyopathy Questionnaire score change from the first physical therapy assessment to one month post-procedure?



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must be ambulatory (with or without an assist device)
  • Subject has severe aortic stenosis and is felt an appropriate candidate for TAVR by the Heart Team.
  • Subject requires 6.0 seconds or longer to complete a 15ft walk test
  • Subject must be able to move between sitting and standing without assistance from another person.
  • Subject has adequate iliac and femoral arterial anatomy to allow for TAVR via transfemoral access
  • Subject is 18 years of age or greater
  • Subject is willing to give consent and participate in the study

Exclusion Criteria:

  • Subject is incapable of following instructions
  • Subject is unable to meet the minimum required physical therapy visits
  • Subject has other medical conditions rendering it unsafe, in the opinion of the Principal Investigator and physical therapy staff, to perform a 6 Minute Walk Test or physical therapy conditioning prior to TAVR
  • Subject has significant severe un-revascularized epicardial coronary disease.

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): NCT03107897


Contacts
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Contact: Rebecca M Eberly, RN 7178514483 reberly2@wellspan.org
Contact: Christine Shaeffer, BSN, RN 7178513408 cshaeffer@wellspan.org

Locations
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United States, Pennsylvania
WellSpan Gettsyburg Hospital Recruiting
Gettysburg, Pennsylvania, United States, 17325
Contact: Rebecca Eberly, RN    717-851-4483    reberly2@wellspan.org   
Penn Medicine Lancaster General Health Recruiting
Lancaster, Pennsylvania, United States, 17602
Contact: Cathy Forney, MBA, MEd    717-544-1777    cforney2@lghealth.org   
Rebecca Eberly Recruiting
Stevens, Pennsylvania, United States, 17578
Contact: Rebecca M Eberly, RN    717-851-4483    reberly2@wellspan.org   
Contact: Christine Shaeffer, BSN, RN    7178513408    cshaeffer@wellspan.org   
Sponsors and Collaborators
WellSpan Health
Lancaster General Hospital

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Responsible Party: James Harvey, Principal Investigator, WellSpan Health
ClinicalTrials.gov Identifier: NCT03107897     History of Changes
Other Study ID Numbers: TAVR Prehab
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by James Harvey, WellSpan Health:
TAVR
elevated frailty score
Transcatheter Valve Replacement

Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction