Clinical trial NCT03270124: 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
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
Keywords: Aortic Valve Stenosis
Fitbit
iPAD
Physical Exercises
Quality of Life
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Edwards Lifesciences
First posted: 2017-09-01
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Average Daily Steps
timeFrame: Randomization to 6 weeks
measure: Short Physical Performance Battery score
timeFrame: 6 week value, adjusted for baseline value
measure: Quality of Life as measured with the KCCQ Overall Summary Score
timeFrame: 6 week value, adjusted for baseline value
Secondary outcomes:
measure: 5 meter gait time at the end of the intervention period
timeFrame: Randomization to 6 weeks
measure: Chair Sit to Stand Test
timeFrame: 6 week value, adjusted for baseline value
measure: Balance Test Score at the end of the intervention period
timeFrame: Randomization to 6 weeks
measure: 6 minute walk
timeFrame: 6 week value, adjusted for baseline value
measure: Handgrip
timeFrame: 6 week value, adjusted for baseline value
measure: Average number of hours per day with 250 or more steps
timeFrame: Randomization to 6 weeks
measure: Average Global Physical Health as assessed by the PROMIS Global Health 10 Short Form
timeFrame: Randomization to 6 weeks
measure: Average Global Mental Health as assessed by the PROMIS Global Health 10 Short Form
timeFrame: Randomization to 6 weeks
measure: Physical Function as assessed by the NIH PROMIS computerized adaptive test
timeFrame: Randomization to 6 weeks
measure: Depression as assessed by the NIH PROMIS computerized adaptive test
timeFrame: Randomization to 6 weeks
measure: Fatigue as assessed by the NIH PROMIS computerized adaptive test
timeFrame: Randomization to 6 weeks
measure: Dyspnea as assessed by the NIH PROMIS computerized adaptive test
timeFrame: Randomization to 6 weeks
measure: Daily Active Minutes (total)
timeFrame: Randomization to 6 weeks
measure: Daily Active Minutes of Moderate to High Intensity
timeFrame: Randomization to 6 weeks
measure: Sedentary Minutes
timeFrame: Randomization to 6 weeks
measure: Daily Steps
timeFrame: 6 weeks post baseline to end of study
measure: Daily Active Minutes (total)
timeFrame: 6 weeks post baseline to end of study
measure: Daily Active Minutes of Moderate to High Intensity
timeFrame: 6 weeks post baseline to end of study
measure: Daily Sedentary Minutes
timeFrame: 6 weeks post baseline to end of study
measure: KCCQ Overall Summary Score
timeFrame: 6 weeks post baseline to end of study
measure: Global Physical Health
timeFrame: 6 weeks post baseline to end of study
measure: Global Mental Health
timeFrame: 6 weeks post baseline to end of study
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Morristown
country: United States
facility: Atlantic Health - Morristown Medical Center
state: New Jersey
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Vanderbilt University Medical Center
name: Brian R Lindman, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.