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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A pragmatiC sTrategy to Promote actIVity and Enhance Quality of Life AFTER Transcatheter Aortic Valve Replacement (ACTIVE AFTER TAVR): A Pilot Study

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Behavioral: Daily Activity Goal
* Behavioral: Resistance Exercises
* Behavioral: Daily Activity Recording


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: No Resistance Exercise and No Activity Goal Arm<br>Blinded use of Fitbit with no daily activity goal and no resistance exercises | Behavioral: Daily Activity Recording<br>* A Fitbit will be worn by all participants to record daily activity.<br>|
| Experimental: Resistance Exercise and Activity Goal Arm<br>Unblinded use of Fitbit with a daily activity goal (steps per day) and resistance exercises | Behavioral: Daily Activity Goal<br>* Patients are given a tailored daily activity goal in terms of steps per day for which to aim.<br>* Other names: Resistance Exercise and Activity Goal Arm;Behavioral: Resistance Exercises<br>* 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.<br>* Other names: Resistance Exercise and Activity Goal Arm;Behavioral: Daily Activity Recording<br>* A Fitbit will be worn by all participants to record daily activity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Daily Steps | Average daily steps over the intervention period | Randomization to 6 weeks | 
| Short Physical Performance Battery score | Combination of gait speed, balance test, and chair-to-stand test at the end of the intervention | 6 week value, adjusted for baseline value | 
| Quality of Life as measured with the KCCQ Overall Summary Score | KCCQ overall summary score | 6 week value, adjusted for baseline value | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5 meter gait time at the end of the intervention period | 5 meter gait time at the end of the intervention period, adjusted for baseline | Randomization to 6 weeks | 
| Chair Sit to Stand Test | Time to complete 5 chair stands | 6 week value, adjusted for baseline value | 
| Balance Test Score at the end of the intervention period | Balance Test Score at the end of the intervention period, adjusted for baseline | Randomization to 6 weeks | 
| 6 minute walk | 6 minute walk distance at the end of the intervention period | 6 week value, adjusted for baseline value | 
| Handgrip | Handgrip strength | 6 week value, adjusted for baseline value | 
| Average number of hours per day with 250 or more steps | Average number of hours per day with 250 or more steps over the intervention period | Randomization to 6 weeks | 
| Average Global Physical Health as assessed by the PROMIS Global Health 10 Short Form | Average Global Physical Health as assessed by the PROMIS Global Health 10 Short Form over the intervention period | Randomization to 6 weeks | 
| Average Global Mental Health as assessed by the PROMIS Global Health 10 Short Form | Average Global Mental Health as assessed by the PROMIS Global Health 10 Short Form over the intervention period | Randomization to 6 weeks | 
| Physical Function as assessed by the NIH PROMIS computerized adaptive test | Physical Function as assessed by the NIH PROMIS computerized adaptive test, adjusted for baseline | Randomization to 6 weeks | 
| Depression as assessed by the NIH PROMIS computerized adaptive test | Depression as assessed by the NIH PROMIS computerized adaptive test, adjusted for baseline | Randomization to 6 weeks | 
| Fatigue as assessed by the NIH PROMIS computerized adaptive test | Fatigue as assessed by the NIH PROMIS computerized adaptive test, adjusted for baseline | Randomization to 6 weeks | 
| Dyspnea as assessed by the NIH PROMIS computerized adaptive test | Dyspnea as assessed by the NIH PROMIS computerized adaptive test, adjusted for baseline | Randomization to 6 weeks | 
| Daily Active Minutes (total) | Average daily active minutes (total) | Randomization to 6 weeks | 
| Daily Active Minutes of Moderate to High Intensity | Average daily minutes of moderate to high intensity | Randomization to 6 weeks | 
| Sedentary Minutes | Average daily sedentary minutes | Randomization to 6 weeks | 
| Daily Steps | Average daily steps | 6 weeks post baseline to end of study | 
| Daily Active Minutes (total) | Average daily active minutes (total) | 6 weeks post baseline to end of study | 
| Daily Active Minutes of Moderate to High Intensity | Average daily active minutes of moderate to high intensity | 6 weeks post baseline to end of study | 
| Daily Sedentary Minutes | Average daily sedentary minutes | 6 weeks post baseline to end of study | 
| KCCQ Overall Summary Score | KCCQ overall summary score, adjusted for baseline | 6 weeks post baseline to end of study | 
| Global Physical Health | Global physical health as assessed by the PROMIS Global Health 10 Short Form, adjusted for baseline | 6 weeks post baseline to end of study | 
| Global Mental Health | Global mental health as assessed by the PROMIS Global Health 10 Short Form, adjusted for baseline | 6 weeks post baseline to end of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fitbit, Aortic Valve Stenosis, iPAD, Physical Exercises, Quality of Life