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

March 29, 2021 updated by: Brian Lindman, Vanderbilt University Medical Center

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
85

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Average Daily Steps
Time Frame: Randomization to 6 weeks
Average daily steps over the intervention period
Randomization to 6 weeks
Short Physical Performance Battery score
Time Frame: 6 week value, adjusted for baseline value
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
Time Frame: 6 week value, adjusted for baseline value
KCCQ overall summary score
6 week value, adjusted for baseline value

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
5 meter gait time at the end of the intervention period
Time Frame: Randomization to 6 weeks
5 meter gait time at the end of the intervention period, adjusted for baseline
Randomization to 6 weeks
Chair Sit to Stand Test
Time Frame: 6 week value, adjusted for baseline value
Time to complete 5 chair stands
6 week value, adjusted for baseline value
Balance Test Score at the end of the intervention period
Time Frame: Randomization to 6 weeks
Balance Test Score at the end of the intervention period, adjusted for baseline
Randomization to 6 weeks
6 minute walk
Time Frame: 6 week value, adjusted for baseline value
6 minute walk distance at the end of the intervention period
6 week value, adjusted for baseline value
Handgrip
Time Frame: 6 week value, adjusted for baseline value
Handgrip strength
6 week value, adjusted for baseline value
Average number of hours per day with 250 or more steps
Time Frame: Randomization to 6 weeks
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
Time Frame: Randomization to 6 weeks
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
Time Frame: Randomization to 6 weeks
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
Time Frame: Randomization to 6 weeks
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
Time Frame: Randomization to 6 weeks
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
Time Frame: Randomization to 6 weeks
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
Time Frame: Randomization to 6 weeks
Dyspnea as assessed by the NIH PROMIS computerized adaptive test, adjusted for baseline
Randomization to 6 weeks
Daily Active Minutes (total)
Time Frame: Randomization to 6 weeks
Average daily active minutes (total)
Randomization to 6 weeks
Daily Active Minutes of Moderate to High Intensity
Time Frame: Randomization to 6 weeks
Average daily minutes of moderate to high intensity
Randomization to 6 weeks
Sedentary Minutes
Time Frame: Randomization to 6 weeks
Average daily sedentary minutes
Randomization to 6 weeks
Daily Steps
Time Frame: 6 weeks post baseline to end of study
Average daily steps
6 weeks post baseline to end of study
Daily Active Minutes (total)
Time Frame: 6 weeks post baseline to end of study
Average daily active minutes (total)
6 weeks post baseline to end of study
Daily Active Minutes of Moderate to High Intensity
Time Frame: 6 weeks post baseline to end of study
Average daily active minutes of moderate to high intensity
6 weeks post baseline to end of study
Daily Sedentary Minutes
Time Frame: 6 weeks post baseline to end of study
Average daily sedentary minutes
6 weeks post baseline to end of study
KCCQ Overall Summary Score
Time Frame: 6 weeks post baseline to end of study
KCCQ overall summary score, adjusted for baseline
6 weeks post baseline to end of study
Global Physical Health
Time Frame: 6 weeks post baseline to end of study
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
Time Frame: 6 weeks post baseline to end of study
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vanderbilt University Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Edwards Lifesciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Brian R Lindman, MD, Vanderbilt University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 7, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 24, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 25, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 29, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 1, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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