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

Completed · Not applicable

Conditions studied: Aortic Valve Stenosis

In brief

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 fitness tracking device (Fitbit Alta HR) 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.

Key facts

Study ID

NCT03270124

Run by

Vanderbilt University Medical Center

People needed

85

Starts

2017-11-07

Expected to finish

2020-03-25

Last updated by the study team

2021-04-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 Fitbit during Phase 1 (e.g. not wearing the Fitbit at least 10 waking hours a day for at least 5 days a week)
• Unwillingness or inability of the subject to provide informed consent for Phases 2/3 (no LARs allowed)

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Atlantic Health - Morristown Medical Center — Morristown, New Jersey, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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