NCT03270124

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 1, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

November 7, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2020

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

2.4 years

First QC Date

August 29, 2017

Last Update Submit

March 29, 2021

Conditions

Aortic Valve Stenosis

Keywords

Aortic Valve StenosisFitbitiPADPhysical ExercisesQuality of Life

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (22)

  • 5 meter gait time at the end of the intervention period

    Randomization to 6 weeks

  • Chair Sit to Stand Test

    6 week value, adjusted for baseline value

  • Balance Test Score at the end of the intervention period

    Randomization to 6 weeks

  • 6 minute walk

    6 week value, adjusted for baseline value

  • Handgrip

    6 week value, adjusted for baseline value

  • +17 more secondary outcomes

Study Arms (2)

No Resistance Exercise and No Activity Goal Arm

ACTIVE COMPARATOR

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

Behavioral: Daily Activity Recording

Resistance Exercise and Activity Goal Arm

EXPERIMENTAL

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

Behavioral: Daily Activity GoalBehavioral: Resistance ExercisesBehavioral: Daily Activity Recording

Interventions

Daily Activity GoalBEHAVIORAL

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

Also known as: Resistance Exercise and Activity Goal Arm
Resistance Exercise and Activity Goal Arm
Resistance ExercisesBEHAVIORAL

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.

Also known as: Resistance Exercise and Activity Goal Arm
Resistance Exercise and Activity Goal Arm
Daily Activity RecordingBEHAVIORAL

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

No Resistance Exercise and No Activity Goal ArmResistance Exercise and Activity Goal Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Atlantic Health - Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (2)

  • 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.

    PMID: 34048509BACKGROUND

  • 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.

    PMID: 33962483DERIVED

MeSH Terms

Conditions

Aortic Valve StenosisMotor Activity

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow ObstructionBehavior

Study Officials

  • Brian R Lindman, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 29, 2017

First Posted

September 1, 2017

Study Start

November 7, 2017

Primary Completion

March 24, 2020

Study Completion

March 25, 2020

Last Updated

April 1, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(5)