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
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
- to improve physical functioning by the time of TAVR and to sustain benefit through 30 days post-procedure; and
- 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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|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)|
|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|
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.
Eight - Twelve visits to physical therapy prior to their TAVR procedure.
- 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?
- 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?
- 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?
- 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?
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
|Contact: Rebecca M Eberly, RNfirstname.lastname@example.org|
|Contact: Christine Shaeffer, BSN, RNemail@example.com|
|United States, Pennsylvania|
|WellSpan Gettsyburg Hospital||Recruiting|
|Gettysburg, Pennsylvania, United States, 17325|
|Contact: Rebecca Eberly, RN 717-851-4483 firstname.lastname@example.org|
|Penn Medicine Lancaster General Health||Recruiting|
|Lancaster, Pennsylvania, United States, 17602|
|Contact: Cathy Forney, MBA, MEd 717-544-1777 email@example.com|
|Stevens, Pennsylvania, United States, 17578|
|Contact: Rebecca M Eberly, RN 717-851-4483 firstname.lastname@example.org|
|Contact: Christine Shaeffer, BSN, RN 7178513408 email@example.com|