Ignite Creation Date:
2024-05-06 @ 10:29 AM
Last Modification Date:
2024-10-26 @ 12:30 PM
Study NCT ID:
NCT03270124
Status:
COMPLETED
Last Update Posted:
2021-04-01
First Post:
2017-08-29
Brief Title:
A pragmatiC sTrategy to Promote actIVity and Enhance Quality of Life AFTER Transcatheter Aortic Valve Replacement
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
A pragmatiC sTrategy to Promote actIVity and Enhance Quality of Life AFTER Transcatheter Aortic Valve Replacement ACTIVE AFTER TAVR A Pilot Study
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None