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

Primary Purpose

Aortic Valve Stenosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Daily Activity Goal
Resistance Exercises
Daily Activity Recording
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring Aortic Valve Stenosis, Fitbit, iPAD, Physical Exercises, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Massachusetts General Hospital
  • Dartmouth-Hitchcock Medical Center
  • Atlantic Health - Morristown Medical Center
  • Vanderbilt University Medical Center
  • University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

No Resistance Exercise and No Activity Goal Arm

Resistance Exercise and Activity Goal Arm

Arm Description

Blinded use of Fitbit with no daily activity goal and no resistance exercises

Unblinded use of Fitbit with a daily activity goal (steps per day) and resistance exercises

Outcomes

Primary Outcome Measures

Average Daily Steps
Average daily steps over the intervention period
Short Physical Performance Battery score
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
KCCQ overall summary score

Secondary Outcome Measures

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
Chair Sit to Stand Test
Time to complete 5 chair stands
Balance Test Score at the end of the intervention period
Balance Test Score at the end of the intervention period, adjusted for baseline
6 minute walk
6 minute walk distance at the end of the intervention period
Handgrip
Handgrip strength
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
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
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
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
Depression as assessed by the NIH PROMIS computerized adaptive test
Depression as assessed by the NIH PROMIS computerized adaptive test, adjusted for baseline
Fatigue as assessed by the NIH PROMIS computerized adaptive test
Fatigue as assessed by the NIH PROMIS computerized adaptive test, adjusted for baseline
Dyspnea as assessed by the NIH PROMIS computerized adaptive test
Dyspnea as assessed by the NIH PROMIS computerized adaptive test, adjusted for baseline
Daily Active Minutes (total)
Average daily active minutes (total)
Daily Active Minutes of Moderate to High Intensity
Average daily minutes of moderate to high intensity
Sedentary Minutes
Average daily sedentary minutes
Daily Steps
Average daily steps
Daily Active Minutes (total)
Average daily active minutes (total)
Daily Active Minutes of Moderate to High Intensity
Average daily active minutes of moderate to high intensity
Daily Sedentary Minutes
Average daily sedentary minutes
KCCQ Overall Summary Score
KCCQ overall summary score, adjusted for baseline
Global Physical Health
Global physical health as assessed by the PROMIS Global Health 10 Short Form, adjusted for baseline
Global Mental Health
Global mental health as assessed by the PROMIS Global Health 10 Short Form, adjusted for baseline

Full Information

First Posted
August 29, 2017
Last Updated
March 29, 2021
Sponsor
Vanderbilt University Medical Center
Collaborators
Edwards Lifesciences
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1. Study Identification

Unique Protocol Identification Number
NCT03270124
Brief Title
A pragmatiC sTrategy to Promote actIVity and Enhance Quality of Life AFTER Transcatheter Aortic Valve Replacement
Official Title
A pragmatiC sTrategy to Promote actIVity and Enhance Quality of Life AFTER Transcatheter Aortic Valve Replacement (ACTIVE AFTER TAVR): A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 7, 2017 (Actual)
Primary Completion Date
March 24, 2020 (Actual)
Study Completion Date
March 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
Edwards Lifesciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis
Keywords
Aortic Valve Stenosis, Fitbit, iPAD, Physical Exercises, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Resistance Exercise and No Activity Goal Arm
Arm Type
Active Comparator
Arm Description
Blinded use of Fitbit with no daily activity goal and no resistance exercises
Arm Title
Resistance Exercise and Activity Goal Arm
Arm Type
Experimental
Arm Description
Unblinded use of Fitbit with a daily activity goal (steps per day) and resistance exercises
Intervention Type
Behavioral
Intervention Name(s)
Daily Activity Goal
Other Intervention Name(s)
Resistance Exercise and Activity Goal Arm
Intervention Description
Patients are given a tailored daily activity goal in terms of steps per day for which to aim.
Intervention Type
Behavioral
Intervention Name(s)
Resistance Exercises
Other Intervention Name(s)
Resistance Exercise and Activity Goal Arm
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Daily Activity Recording
Intervention Description
A Fitbit will be worn by all participants to record daily activity.
Primary Outcome Measure Information:
Title
Average Daily Steps
Description
Average daily steps over the intervention period
Time Frame
Randomization to 6 weeks
Title
Short Physical Performance Battery score
Description
Combination of gait speed, balance test, and chair-to-stand test at the end of the intervention
Time Frame
6 week value, adjusted for baseline value
Title
Quality of Life as measured with the KCCQ Overall Summary Score
Description
KCCQ overall summary score
Time Frame
6 week value, adjusted for baseline value
Secondary Outcome Measure Information:
Title
5 meter gait time at the end of the intervention period
Description
5 meter gait time at the end of the intervention period, adjusted for baseline
Time Frame
Randomization to 6 weeks
Title
Chair Sit to Stand Test
Description
Time to complete 5 chair stands
Time Frame
6 week value, adjusted for baseline value
Title
Balance Test Score at the end of the intervention period
Description
Balance Test Score at the end of the intervention period, adjusted for baseline
Time Frame
Randomization to 6 weeks
Title
6 minute walk
Description
6 minute walk distance at the end of the intervention period
Time Frame
6 week value, adjusted for baseline value
Title
Handgrip
Description
Handgrip strength
Time Frame
6 week value, adjusted for baseline value
Title
Average number of hours per day with 250 or more steps
Description
Average number of hours per day with 250 or more steps over the intervention period
Time Frame
Randomization to 6 weeks
Title
Average Global Physical Health as assessed by the PROMIS Global Health 10 Short Form
Description
Average Global Physical Health as assessed by the PROMIS Global Health 10 Short Form over the intervention period
Time Frame
Randomization to 6 weeks
Title
Average Global Mental Health as assessed by the PROMIS Global Health 10 Short Form
Description
Average Global Mental Health as assessed by the PROMIS Global Health 10 Short Form over the intervention period
Time Frame
Randomization to 6 weeks
Title
Physical Function as assessed by the NIH PROMIS computerized adaptive test
Description
Physical Function as assessed by the NIH PROMIS computerized adaptive test, adjusted for baseline
Time Frame
Randomization to 6 weeks
Title
Depression as assessed by the NIH PROMIS computerized adaptive test
Description
Depression as assessed by the NIH PROMIS computerized adaptive test, adjusted for baseline
Time Frame
Randomization to 6 weeks
Title
Fatigue as assessed by the NIH PROMIS computerized adaptive test
Description
Fatigue as assessed by the NIH PROMIS computerized adaptive test, adjusted for baseline
Time Frame
Randomization to 6 weeks
Title
Dyspnea as assessed by the NIH PROMIS computerized adaptive test
Description
Dyspnea as assessed by the NIH PROMIS computerized adaptive test, adjusted for baseline
Time Frame
Randomization to 6 weeks
Title
Daily Active Minutes (total)
Description
Average daily active minutes (total)
Time Frame
Randomization to 6 weeks
Title
Daily Active Minutes of Moderate to High Intensity
Description
Average daily minutes of moderate to high intensity
Time Frame
Randomization to 6 weeks
Title
Sedentary Minutes
Description
Average daily sedentary minutes
Time Frame
Randomization to 6 weeks
Title
Daily Steps
Description
Average daily steps
Time Frame
6 weeks post baseline to end of study
Title
Daily Active Minutes (total)
Description
Average daily active minutes (total)
Time Frame
6 weeks post baseline to end of study
Title
Daily Active Minutes of Moderate to High Intensity
Description
Average daily active minutes of moderate to high intensity
Time Frame
6 weeks post baseline to end of study
Title
Daily Sedentary Minutes
Description
Average daily sedentary minutes
Time Frame
6 weeks post baseline to end of study
Title
KCCQ Overall Summary Score
Description
KCCQ overall summary score, adjusted for baseline
Time Frame
6 weeks post baseline to end of study
Title
Global Physical Health
Description
Global physical health as assessed by the PROMIS Global Health 10 Short Form, adjusted for baseline
Time Frame
6 weeks post baseline to end of study
Title
Global Mental Health
Description
Global mental health as assessed by the PROMIS Global Health 10 Short Form, adjusted for baseline
Time Frame
6 weeks post baseline to end of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian R Lindman, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Atlantic Health - Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34048509
Citation
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.
Results Reference
background
PubMed Identifier
33962483
Citation
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.
Results Reference
derived
Links:
URL
https://academic.oup.com/ehjdh/advance-article/doi/10.1093/ehjdh/ztab007/6128571?login=true
Description
Effect of a Pragmatic Home-Based Mobile Health Exercise Intervention After Transcatheter Aortic Valve Replacement.

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

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