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A STEP for Patients Prior to Undergoing TAVR: A Pilot Study

NCT02766075 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2018-04-12

No results posted yet for this study

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).

Conditions

  • Frail Elderly
  • Aortic Valve Stenosis

Interventions

BEHAVIORAL

Supervised TAVR Exercise Program

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.

Sponsors & Collaborators

  • HeartCare Midwest

    collaborator UNKNOWN

  • University of Illinois College of Medicine at Peoria

    collaborator OTHER

  • OSF Healthcare System

    lead OTHER

Principal Investigators

  • Jay N Patel, MD · OSF Healthcare System

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2018-02-28
Completion
2018-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02766075 on ClinicalTrials.gov