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

Not Applicable

Completed

• Conditions: Aortic Valve Stenosis
• Interventions: Behavioral: Daily Activity Recording; Behavioral: Daily Activity Goal; Behavioral: Resistance Exercises

• Registration Number: NCT03270124
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-08-29
• Study First Submitted QC: 2017-08-30
• Study First Posted: 2017-09-01
• Study Start: 2017-11-07
• Primary Completion: 2020-03-24
• Study Completion: 2020-03-25
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-29
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resistance Exercise and Activity Goal Arm	Resistance Exercises	Unblinded use of Fitbit with a daily activity goal (steps per day) and resistance exercises
No Resistance Exercise and No Activity Goal Arm	Daily Activity Recording	Blinded use of Fitbit with no daily activity goal and no resistance exercises
Resistance Exercise and Activity Goal Arm	Daily Activity Goal	Unblinded use of Fitbit with a daily activity goal (steps per day) and resistance exercises
Resistance Exercise and Activity Goal Arm	Daily Activity Recording	Unblinded use of Fitbit with a daily activity goal (steps per day) and resistance exercises

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States

Atlantic Health - Morristown Medical Center; 🇺🇸 Morristown, New Jersey, United States