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

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ClinicalTrials.gov Identifier: NCT03270124
Recruitment Status : Recruiting
First Posted : September 1, 2017
Last Update Posted : September 19, 2018
Sponsor:
Collaborator:
Edwards Lifesciences
Information provided by (Responsible Party):
Brian Lindman, 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.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Behavioral: Daily Activity Goal Behavioral: Resistance Exercises Behavioral: Daily Activity Recording Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A pragmatiC sTrategy to Promote actIVity and Enhance Quality of Life AFTER Transcatheter Aortic Valve Replacement (ACTIVE AFTER TAVR): A Pilot Study
Actual Study Start Date : November 7, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : February 2020


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 Goal
Patients are given a tailored daily activity goal in terms of steps per day for which to aim.
Other Name: 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 Name: Resistance Exercise and Activity Goal Arm

Behavioral: Daily Activity Recording
A Fitbit will be worn by all participants to record daily activity.




Primary Outcome Measures :
  1. Average Daily Steps [ Time Frame: Randomization to 6 weeks ]
    Average daily steps over the intervention period

  2. 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

  3. Quality of Life as measured with the KCCQ Overall Summary Score [ Time Frame: 6 week value, adjusted for baseline value ]
    KCCQ overall summary score


Secondary Outcome Measures :
  1. 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

  2. Chair Sit to Stand Test [ Time Frame: 6 week value, adjusted for baseline value ]
    Time to complete 5 chair stands

  3. 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

  4. 6 minute walk [ Time Frame: 6 week value, adjusted for baseline value ]
    6 minute walk distance at the end of the intervention period

  5. Handgrip [ Time Frame: 6 week value, adjusted for baseline value ]
    Handgrip strength

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03270124


Contacts
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Contact: Stephanie A Smith, MA 615-936-0815 Stephanie.anne.smith@vumc.org
Contact: Brian R Lindman, MD brian.r.lindman@vanderbilt.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Phoebe Erickson    617-643-1374    perickson2@mgh.harvard.edu   
Principal Investigator: Sammy Elmariah, MD         
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Deb Mitchell    603-650-8239    deborah.mitchell@hitchcock.org   
Contact: Henry Stokes    603-650-6228 ext 7179    henry.c.stokes@hitchcock.org   
Principal Investigator: Megan Coylewright, MD         
United States, New Jersey
Atlantic Health - Morristown Medical Center Recruiting
Morristown, New Jersey, United States, 07960
Contact: Viraj Bhatt       viraj.bhatt@atlantichealth.org   
Contact: Julie Thompson    973-971-5465    julianne.thompson@atlantichealth.org   
Principal Investigator: Linda Gillam, MD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37203
Contact: Harry Cloud    615-936-1720    harrison.l.cloud@vanderbilt.edu   
Contact: Natalie Jackson    615-343-1782    natalie.jackson@vumc.org   
Principal Investigator: Brian R Lindman, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Jaymee Sanderson    801-585-2975    jaymee.sanderson@hsc.utah.edu   
Principal Investigator: Fred Welt, MD         
Sponsors and Collaborators
Vanderbilt University Medical Center
Edwards Lifesciences
Investigators
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Principal Investigator: Brian R Lindman, MD Vanderbilt University Medical Center

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Responsible Party: Brian Lindman, Associate Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03270124     History of Changes
Other Study ID Numbers: ACTIVE AFTER TAVR
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Brian Lindman, Vanderbilt University Medical Center:
Aortic Valve Stenosis
Fitbit
iPAD
Physical Exercises
Quality of Life

Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction