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

Aortic Valve Stenosis Clinical Trial

Official title:

A pragmatiC sTrategy to Promote actIVity and Enhance Quality of Life AFTER Transcatheter Aortic Valve Replacement (ACTIVE AFTER TAVR): A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03270124
• Other study ID #: ACTIVE AFTER TAVR
• Status: Completed
• Phase: N/A
• Start date: November 7, 2017
• Est. completion date: March 25, 2020

Study information

• Verified date: March 2021
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: March 25, 2020
• Est. primary completion date: March 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Behavioral:
• Daily Activity Goal
Patients are given a tailored daily activity goal in terms of steps per day for which to aim.
• 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.
• Daily Activity Recording
A Fitbit will be worn by all participants to record daily activity.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Atlantic Health - Morristown Medical Center	Morristown	New Jersey
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	University of Utah	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Edwards Lifesciences

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Effect of a Pragmatic Home-Based Mobile Health Exercise Intervention After Transcatheter Aortic Valve Replacement: A Randomized Pilot Trial. European Heart Journal - Digital Health 2021. Published online February 4, 2021. https://doi.org/10.1093/ehjdh/ztab007

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Daily Steps	Average daily steps over the intervention period	Randomization to 6 weeks
Primary	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
Primary	Quality of Life as measured with the KCCQ Overall Summary Score	KCCQ overall summary score	6 week value, adjusted for baseline value
Secondary	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	Randomization to 6 weeks
Secondary	Chair Sit to Stand Test	Time to complete 5 chair stands	6 week value, adjusted for baseline value
Secondary	Balance Test Score at the end of the intervention period	Balance Test Score at the end of the intervention period, adjusted for baseline	Randomization to 6 weeks
Secondary	6 minute walk	6 minute walk distance at the end of the intervention period	6 week value, adjusted for baseline value
Secondary	Handgrip	Handgrip strength	6 week value, adjusted for baseline value
Secondary	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	Randomization to 6 weeks
Secondary	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	Randomization to 6 weeks
Secondary	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	Randomization to 6 weeks
Secondary	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	Randomization to 6 weeks
Secondary	Depression as assessed by the NIH PROMIS computerized adaptive test	Depression as assessed by the NIH PROMIS computerized adaptive test, adjusted for baseline	Randomization to 6 weeks
Secondary	Fatigue as assessed by the NIH PROMIS computerized adaptive test	Fatigue as assessed by the NIH PROMIS computerized adaptive test, adjusted for baseline	Randomization to 6 weeks
Secondary	Dyspnea as assessed by the NIH PROMIS computerized adaptive test	Dyspnea as assessed by the NIH PROMIS computerized adaptive test, adjusted for baseline	Randomization to 6 weeks
Secondary	Daily Active Minutes (total)	Average daily active minutes (total)	Randomization to 6 weeks
Secondary	Daily Active Minutes of Moderate to High Intensity	Average daily minutes of moderate to high intensity	Randomization to 6 weeks
Secondary	Sedentary Minutes	Average daily sedentary minutes	Randomization to 6 weeks
Secondary	Daily Steps	Average daily steps	6 weeks post baseline to end of study
Secondary	Daily Active Minutes (total)	Average daily active minutes (total)	6 weeks post baseline to end of study
Secondary	Daily Active Minutes of Moderate to High Intensity	Average daily active minutes of moderate to high intensity	6 weeks post baseline to end of study
Secondary	Daily Sedentary Minutes	Average daily sedentary minutes	6 weeks post baseline to end of study
Secondary	KCCQ Overall Summary Score	KCCQ overall summary score, adjusted for baseline	6 weeks post baseline to end of study
Secondary	Global Physical Health	Global physical health as assessed by the PROMIS Global Health 10 Short Form, adjusted for baseline	6 weeks post baseline to end of study
Secondary	Global Mental Health	Global mental health as assessed by the PROMIS Global Health 10 Short Form, adjusted for baseline	6 weeks post baseline to end of study

External Links

•   Effect of a Pragmatic Home-Based Mobile Health Exercise Intervention After Transcatheter Aortic Valve Replacement.