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

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

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.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Behavioral: Daily Activity Recording; Behavioral: Daily Activity Goal; Behavioral: Resistance Exercises

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.

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Atlantic Health - Morristown Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Vanderbilt University Medical Center
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Recording; A Fitbit will be worn by all participants to record daily activity.; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: Edwards Lifesciences
• Investigators: Principal Investigator: Brian R Lindman, MD, Vanderbilt University Medical Center

Publications and helpful links

General Publications

• Abraham LN, Sibilitz KL, Berg SK, Tang LH, Risom SS, Lindschou J, Taylor RS, Borregaard B, Zwisler AD. Exercise-based cardiac rehabilitation for adults after heart valve surgery. Cochrane Database Syst Rev. 2021 May 7;5(5):CD010876. doi: 10.1002/14651858.CD010876.pub3.
• Lindman BR, Gillam LD, Coylewright M, Welt FGP, Elmariah S, Smith SA, McKeel DA, Jackson N, Mukerjee K, Cloud H, Hanna N, Purpura J, Ellis H, Martinez V, Selberg AM, Huang S, Harrell FE Jr. Effect of a pragmatic home-based mobile health exercise intervention after transcatheter aortic valve replacement: a randomized pilot trial. Eur Heart J Digit Health. 2021 Feb 4;2(1):90-103. doi: 10.1093/ehjdh/ztab007. eCollection 2021 Mar. Erratum In: Eur Heart J Digit Health. 2021 Nov 21;3(1):115-116.

Helpful Links

• Effect of a Pragmatic Home-Based Mobile Health Exercise Intervention After Transcatheter Aortic Valve Replacement.

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2017
• Primary Completion (Actual): March 24, 2020
• Study Completion (Actual): March 25, 2020

Study Registration Dates

• First Submitted: August 29, 2017
• First Submitted That Met QC Criteria: August 30, 2017
• First Posted (Actual): September 1, 2017

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 29, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Quality of Life; Aortic Valve Stenosis; Fitbit; iPAD; Physical Exercises
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: ACTIVE AFTER TAVR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No