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OpenTrials
Completed

NCT Number: NCT03107897

Prehabilitation for Patients Undergoing Transcatheter Aortic Valve Replacement

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.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wellspan York Hospital

York, Pennsylvania, 17403, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pre-habilitation

Other

Eight - Twelve visits to physical therapy prior to their TAVR procedure.

Primary outcomes

  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 outcomes

  1. Mobility - Timed Up and Go Test (TUG)

    Time frame: One month

    Does prehabilitation improve the subject's mobility from first physical therapy assessment to pre-procedure assessment and first PT assessment to one month post-procedure, as measured by the TUG test?

  2. Balance - Four Square Step Test (FSST)

    Time frame: One month

    Does prehabilitation improve the subject's balance from first physical therapy assessment to preprocedure assessment and first PT assessment to one month post-procedure, as measured by the FSST?

  3. Discharge Disposition

    Time frame: 24-48 hours post procedure

    Does prehabilitation make it less likely that a patient will require a higher level of care at discharge than they require prior to admission (for example, arrive from home and discharged to home)?

  4. Length of stay in the ICU

    Time frame: TAVR procedure admission

    Hours total spent in the ICU for TAVR procedure admission

  5. Total hospital length of stay

    Time frame: TAVR procedure admission

    Days total spent in the hospital for TAVR procedure admission

  6. Change in Quality of Life (KCCQ)

    Time frame: One month

    Does the Kansas City Cardiomyopathy Questionnaire score change from the first physical therapy assessment to one month post-procedure?

  7. 30 day readmission

    Time frame: 30 days post procedure

    Does the subject have a 30 day re-admission post-procedure?

Sponsors and collaborators

Lead sponsor

WellSpan Health

Other

Registry information

Acronym: TAVR-Prehab

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Apr 11, 2017
Registry last updated
Jun 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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