A pragmatiC sTrategy to Promote actIVity and Enhance Quality of Life AFTER Transcatheter Aortic Valve Replacement

Description

This study is being performed in patients who have undergone transcatheter aortic valve replacement (TAVR) for aortic stenosis. The goal is to obtain pilot and feasibility data on a novel post-procedure rehabilitation strategy, including a daily activity goal using a waist-worn accelerometer and in-home resistance training exercises targeting muscles related to activities of daily living. We will evaluate the effect of these interventions on physical performance and several quality of life domains.

Study Start Date

November, 07 2017

Estimated Completion Date

September 2020

Interventions

  • Behavioral: Resistance Exercises
  • Behavioral: Daily Activity Recording
  • Behavioral: Daily Activity Goal

Study ID

Vanderbilt University Medical Center -- ACTIVE AFTER TAVR

Status

Recruiting

Trial ID

NCT03270124

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

50

Sponsor

Vanderbilt University Medical Center

Inclusion Criteria

    Phase 1
  • Starts after the TAVR procedure and prior to discharge • Patients treated commercially with TAVR with a SAPIEN 3 valve Phases 2 and 3
  • Starts at 30 day post-TAVR follow-up visit • Patients enrolled in Phase 1

Exclusion Criteria

    Phase 1
  • Starts after the TAVR procedure and prior to discharge
  • Stroke during or immediately after the TAVR procedure prior to discharge
  • Inability to walk
  • Non-English speaking (because the mobile app and CAT questionnaires are only in English)
  • Physical or neuropsychiatric limitations that would prevent proficient use of the study tools and successful completion of the physical and quality of life assessments. These limitations may include, but are not limited to: blindness, neuropathy, severe tremor or disabling motor deficit, cognitive impairment (documentation of dementia in the medical record), or illiteracy.
  • Unwillingness or inability of the subject to provide informed consent for Phase 1 (no LARs allowed)
  • Planned discharge from hospital to skilled nursing or rehabilitation facility Phases 2 and 3
  • Starts at 30 day post-TAVR follow-up visit
  • All exclusion criteria from Phase 1 apply
  • Stroke during Phase 1
  • Residing in a skilled nursing facility at the 30 day post-TAVR follow-up visit
  • Patients with unreliable use of the iPad mobile app or accelerometer during Phase 1 (e.g. not wearing the accelerometer or not answering iPad questions 2 or more days per week)
  • Unwillingness or inability of the subject to provide informed consent for Phases 2/3 (no LARs allowed)

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (19)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Deborah Furman 617-643-1374 dfurman2@mgh.harvard.edu
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Deborah Furman 617-643-1374 dfurman2@mgh.harvard.edu
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Deborah Furman 617-643-1374 dfurman2@mgh.harvard.edu
DartmouthHitchcock Medical Center - Lebanon, New Hampshire 105.5 miles Deb Mitchell 603-650-8239 deborah.mitchell@hitchcock.org
DartmouthHitchcock Medical Center - Lebanon, New Hampshire 105.5 miles Deb Mitchell 603-650-8239 deborah.mitchell@hitchcock.org
DartmouthHitchcock Medical Center - Lebanon, New Hampshire 105.5 miles Deb Mitchell 603-650-8239 deborah.mitchell@hitchcock.org
DartmouthHitchcock Medical Center - Lebanon, New Hampshire 105.5 miles Deb Mitchell 603-650-8239 deborah.mitchell@hitchcock.org
DartmouthHitchcock Medical Center - Lebanon, New Hampshire 105.5 miles Deb Mitchell 603-650-8239 deborah.mitchell@hitchcock.org
Atlantic Health Morristown Medical Center - Morristown, New Jersey 206.4 miles Diane Agar None diane.agar@atlantichealth.org
Atlantic Health Morristown Medical Center - Morristown, New Jersey 206.4 miles Diane Agar None diane.agar@atlantichealth.org
Atlantic Health Morristown Medical Center - Morristown, New Jersey 206.4 miles Diane Agar None diane.agar@atlantichealth.org
Atlantic Health Morristown Medical Center - Morristown, New Jersey 206.4 miles Diane Agar None diane.agar@atlantichealth.org
Atlantic Health Morristown Medical Center - Morristown, New Jersey 206.4 miles Diane Agar None diane.agar@atlantichealth.org
Vanderbilt University Medical Center - Nashville, Tennessee 942.8 miles Natalie Jackson 615-343-1782 natalie.jackson@vanderbilt.edu
Vanderbilt University Medical Center - Nashville, Tennessee 942.8 miles Natalie Jackson 615-343-1782 natalie.jackson@vanderbilt.edu
Vanderbilt University Medical Center - Nashville, Tennessee 942.8 miles Natalie Jackson 615-343-1782 natalie.jackson@vanderbilt.edu
University of Utah - Salt Lake City, Utah 2,094.1 miles Jaymee Sanderson 801-585-2975 jaymee.sanderson@hsc.utah.edu
University of Utah - Salt Lake City, Utah 2,094.1 miles Jaymee Sanderson 801-585-2975 jaymee.sanderson@hsc.utah.edu
University of Utah - Salt Lake City, Utah 2,094.1 miles Jaymee Sanderson 801-585-2975 jaymee.sanderson@hsc.utah.edu

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