NCT02766075

Brief Summary

The aim of this pilot study is to establish whether a Supervised TAVR Exercise Program (STEP) can safely improve the frailty status in patients with symptomatic severe aortic valve stenosis prior to undergoing transcatheter aortic valve replacement (TAVR).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
terminated

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

April 28, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 9, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

April 12, 2018

Status Verified

April 1, 2017

Enrollment Period

1.8 years

First QC Date

April 28, 2016

Last Update Submit

April 10, 2018

Conditions

Frail ElderlyAortic Valve Stenosis

Keywords

Transcatheter Aortic Valve DiseaseSupervised TAVR Exercise Program

Outcome Measures

Primary Outcomes (1)

  • Change in Frailty Score from Baseline to post-STEP

    Baseline, 6-weeks

Secondary Outcomes (9)

  • Adverse Events

    6-weeks

  • Change in Frailty Score from Baseline to 30-days post-TAVR

    Baseline, 30-days post-TAVR

  • Change in Gait Speed (5-Meter Walk Test) from Baseline to post-STEP

    Baseline, 6-weeks

  • Change in Gait Speed (5-Meter Walk Test) from Baseline to 30-days post-TAVR

    Baseline, 30-days post-TAVR

  • Change in Grip Strength (Dynamometer) from Baseline to post-STEP

    Baseline, 6-weeks

  • +4 more secondary outcomes

Study Arms (2)

Supervised TAVR Exercise Program (STEP)

EXPERIMENTAL

Subjects in the experimental arm will participate in an individualized 4-week STEP prior to undergoing TAVR. All subjects will undergo serial frailty assessments by a blinded research assistant at baseline, pre-TAVR, and 30-days post-TAVR.

Behavioral: Supervised TAVR Exercise Program

Standard of Care

NO INTERVENTION

Subjects in the no intervention arm will proceed with their TAVR after a minimum 4 weeks without an exercise intervention. All subjects will undergo serial frailty assessments by a blinded research assistant at baseline, pre-TAVR, and 30-days post-TAVR.

Interventions

Supervised TAVR Exercise ProgramBEHAVIORAL

Individualized exercise program designed and implemented by licensed physical therapy clinicians in three 60-minute sessions per week for four weeks. Upon randomization, subjects in the Intervention Group will undergo an initial Dynamic Gait \& Balance Assessment by a licensed physical therapy clinician. The physical therapy clinician will use this assessment to design and implement an individualized STEP in three 60-minute sessions per week for four weeks. Subjects will proceed with their pre-TAVR testing in conjunction with the STEP sessions.

Supervised TAVR Exercise Program (STEP)

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All adult patients scheduled to undergo first-time elective TAVR

You may not qualify if:

  • Vulnerable populations including prisoners, pregnant females and patients less than 18 years age.
  • Patients with history of unstable angina, myocardial infarction, or decompensated heart failure in the week prior to screening
  • Patients with physical limitations (i.e. debilitating stroke, amputation, unable to complete initial screening frailty profile)
  • Patients with advanced dementia or cognitive deficits (i.e. unable to follow instructions of initial screening frailty profile)
  • Exercise-induced arrhythmias

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OSF St. Francis Medical Center

Peoria, Illinois, 61630, United States

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Jay N Patel, MD

    OSF Healthcare System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2016

First Posted

May 9, 2016

Study Start

May 1, 2016

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

April 12, 2018

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)