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Aortic Valve StenosisNCT03270124

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

A study testing Daily Activity Goal, Resistance Exercises and Daily Activity Recording in people with Aortic Valve Stenosis, run by Vanderbilt University Medical Center at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Aortic Valve Stenosis
What is being tested?
Daily Activity Goal, Resistance Exercises and Daily Activity Recording
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
5 sitesUnited States
Study dates
7 Nov 2017to 25 Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 13Show fewer
  • 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)

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Atlantic Health - Morristown Medical Center

    Morristown, New Jersey, 07960

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37203

  • University of Utah

    Salt Lake City, Utah, 84132

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Daily Activity Goal, Resistance Exercises, Daily Activity Recording
Keywords
Aortic Valve Stenosis, Fitbit, iPAD, Physical Exercises, Quality of Life
Medical subject headings
Aortic Valve Stenosis, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Daily Activity GoalBehavioural

    Also called Resistance Exercise and Activity Goal Arm

    Patients are given a tailored daily activity goal in terms of steps per day for which to aim.

  • Resistance ExercisesBehavioural

    Also called Resistance Exercise and Activity Goal Arm

    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.

  • Daily Activity RecordingBehavioural

    A Fitbit will be worn by all participants to record daily activity.

Study groups in NCT03270124
Study groupRoleWhat they receive
No Resistance Exercise and No Activity Goal ArmActive comparatorBlinded use of Fitbit with no daily activity goal and no resistance exercises
Receives: Behavioral: Daily Activity Recording
Resistance Exercise and Activity Goal ArmExperimentalUnblinded use of Fitbit with a daily activity goal (steps per day) and resistance exercises
Receives: Behavioral: Daily Activity Goal; Behavioral: Resistance Exercises; Behavioral: Daily Activity Recording

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average Daily Steps

    Average daily steps over the intervention period

    Measured: Randomization to 6 weeks

  2. Short Physical Performance Battery score

    Combination of gait speed, balance test, and chair-to-stand test at the end of the intervention

    Measured: 6 week value, adjusted for baseline value

  3. Quality of Life as measured with the KCCQ Overall Summary Score

    KCCQ overall summary score

    Measured: 6 week value, adjusted for baseline value

Secondary outcomes (22)

  1. 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

    Measured: Randomization to 6 weeks

  2. Chair Sit to Stand Test

    Time to complete 5 chair stands

    Measured: 6 week value, adjusted for baseline value

  3. Balance Test Score at the end of the intervention period

    Balance Test Score at the end of the intervention period, adjusted for baseline

    Measured: Randomization to 6 weeks

  4. 6 minute walk

    6 minute walk distance at the end of the intervention period

    Measured: 6 week value, adjusted for baseline value

  5. Handgrip

    Handgrip strength

    Measured: 6 week value, adjusted for baseline value

  6. 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

    Measured: Randomization to 6 weeks

  7. 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

    Measured: Randomization to 6 weeks

  8. 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

    Measured: Randomization to 6 weeks

  9. 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

    Measured: Randomization to 6 weeks

  10. Depression as assessed by the NIH PROMIS computerized adaptive test

    Depression as assessed by the NIH PROMIS computerized adaptive test, adjusted for baseline

    Measured: Randomization to 6 weeks

  11. Fatigue as assessed by the NIH PROMIS computerized adaptive test

    Fatigue as assessed by the NIH PROMIS computerized adaptive test, adjusted for baseline

    Measured: Randomization to 6 weeks

  12. Dyspnea as assessed by the NIH PROMIS computerized adaptive test

    Dyspnea as assessed by the NIH PROMIS computerized adaptive test, adjusted for baseline

    Measured: Randomization to 6 weeks

  13. Daily Active Minutes (total)

    Average daily active minutes (total)

    Measured: Randomization to 6 weeks

  14. Daily Active Minutes of Moderate to High Intensity

    Average daily minutes of moderate to high intensity

    Measured: Randomization to 6 weeks

  15. Sedentary Minutes

    Average daily sedentary minutes

    Measured: Randomization to 6 weeks

  16. Daily Steps

    Average daily steps

    Measured: 6 weeks post baseline to end of study

  17. Daily Active Minutes (total)

    Average daily active minutes (total)

    Measured: 6 weeks post baseline to end of study

  18. Daily Active Minutes of Moderate to High Intensity

    Average daily active minutes of moderate to high intensity

    Measured: 6 weeks post baseline to end of study

  19. Daily Sedentary Minutes

    Average daily sedentary minutes

    Measured: 6 weeks post baseline to end of study

  20. KCCQ Overall Summary Score

    KCCQ overall summary score, adjusted for baseline

    Measured: 6 weeks post baseline to end of study

  21. Global Physical Health

    Global physical health as assessed by the PROMIS Global Health 10 Short Form, adjusted for baseline

    Measured: 6 weeks post baseline to end of study

  22. Global Mental Health

    Global mental health as assessed by the PROMIS Global Health 10 Short Form, adjusted for baseline

    Measured: 6 weeks post baseline to end of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2017
  2. Study start7 Nov 2017
  3. Primary completion24 Mar 2020
  4. Study completion25 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03270124
Sponsor's protocol ID
ACTIVE AFTER TAVR
Status last verified
Mar 2021
First submitted
29 Aug 2017
Last updated
1 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34048509

  • 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.

    PubMed 33962483

Questions about this trial

What is this clinical trial studying?

A study testing Daily Activity Goal, Resistance Exercises and Daily Activity Recording in people with Aortic Valve Stenosis, run by Vanderbilt University Medical Center at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average Daily Steps (time frame: Randomization to 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03270124, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.

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