Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 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)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
No Resistance Exercise and No Activity Goal Arm
Blinded use of Fitbit with no daily activity goal and no resistance exercises
  • Behavioral: Daily Activity Recording
    A Fitbit will be worn by all participants to record daily activity.
Experimental
Resistance Exercise and Activity Goal Arm
Unblinded use of Fitbit with a daily activity goal (steps per day) and resistance exercises
  • Behavioral: Daily Activity Goal
    Patients are given a tailored daily activity goal in terms of steps per day for which to aim.
    Other names:
    • Resistance Exercise and Activity Goal Arm
  • Behavioral: Resistance Exercises
    Patients will instructed to perform 3 different resistance exercises targeting muscles pertinent to activities of daily living on 6 out of 7 days a week.
    Other names:
    • Resistance Exercise and Activity Goal Arm
  • Behavioral: Daily Activity Recording
    A Fitbit will be worn by all participants to record daily activity.

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37203
Contact:
Harry Cloud
615-936-1720
harrison.l.cloud@vanderbilt.edu

More Details

NCT ID
NCT03270124
Status
Recruiting
Sponsor
Vanderbilt University Medical Center

Study Contact

Stephanie A Smith, MA
615-936-0815
Stephanie.anne.smith@vumc.org

Detailed Description

The study will be conducted in three phases. Subjects who have been treated commercially with TAVR with a SAPIEN 3 valve and are being discharged to home will be eligible for Phase 1. Once consented prior to discharge, patients will complete the KCCQ, PROMIS Questionnaires, 5m walk, chair stand, and handgrip tests. During phase 1, all subjects will have a Fitbit and answer quality of life questions on the iPad about their activities and quality of life. After 30 days, the subject will return to complete the PROMIS Questionnaires, 5m walk, chair stand, balance tests, and handgrip tests, as well as a KCCQ. If the subject has consistently provided data throughout Phase 1, they will be asked to continue on to Phases 2 and 3 and complete a 6 minute walk test at this baseline visit. For Phase 2, subjects will be randomized to one of two arms. In one arm, they will have a daily activity goal and resistance exercises; in the other arm, there will not be a daily activity goal and no resistance exercises given. After 6 weeks, the subject will return to complete the 5m walk, 6 minute walk test, chair stand, balance tests, and handgrip tests, PROMIS Questionnaires, as well as a KCCQ. Five months after enrollment into Phase 2, subjects will be given a Fitbit to track their daily activity for 1 week (Phase 3). They will also complete a KCCQ, PROMIS Questionnaires, and end of study questionnaire.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.