Kinesiophobia in Patients With Implanted Left Ventricular Assist Devices

February 6, 2026 updated by: Rafet Umut Erdoğan, Marmara University

Kinesiophobia Affects Functional Capacity in Patients With Implanted Left Ventricular Assist Devices

The goal of this prospective and cross-sectional observational study is to learn if the presence and changes in kinesiofobia (fear of movement) affect functional capacity levels in heart failure patients who are transplant candidates and have been implanted with a Left Ventricular Assist Device (LVAD). The main questions it aims to answer are:

i) Does the level of kinesiofobia change significantly 1 month after LVAD implantation? ii) Do changes in kinesiofobia levels predict changes in functional exercise capacity (measured by the 2-Minute Walk Test and 30-Second Sit-to-Stand Test)? Researchers will compare pre-discharge (baseline) measurements to 1-month post-discharge follow-up measurements to see if improvements in kinesiofobia correlate with improved functional mobility and endurance.

Participants will:

i) Complete the Tampa Scale of Kinesiofobia (TSK) to assess their fear of movement.

ii) Perform the 2-Minute Walk Test (2MWT) to evaluate functional exercise capacity and mobility.

iii) Perform the 30-Second Sit-to-Stand Test (30STS) to determine functional endurance and lower extremity performance.

iv) Receive standardized physical activity recommendations upon discharge. v) Return for a follow-up assessment one month later to repeat the same battery of tests.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being a heart transplant candidate and having undergone LVAD implantation,
  • Having a left ventricular ejection fraction (LVEF) <30%,
  • Not having developed any surgical or medical complications in the early period after implantation,
  • Being referred to the study by a cardiologist at the time of discharge,
  • Being able to read and write and volunteering to participate in the study.

Exclusion Criteria:

  • Those with evidence of active infection following implantation,
  • Psychiatric problems developing after LVAD implantation that interfere with cognitive adaptation,
  • Musculoskeletal problems developing after LVAD implantation,
  • Cases experiencing acute cardiac problems requiring hospitalization during follow-up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise Recommendation Group
Patient who recevied physical activity recommendations after LVAD implementation
Diagnostic test: Physical Activity Recommandations
Patients with implanted LVADs will be given recommendations for physical activities they can incorporate into their daily lives.
Other Names:
  • 30 seconds sit to stand test
  • 2 minute walk test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tampa Kinesiophobia Scale
Time Frame: From enrollment to the 4 weeks after the implementation
The Tampa Scale of Kinesiofobia (TSK) is a widely used patient-reported outcome measure designed to quantify a patient's fear of movement and fear of (re)injury. It was originally developed to assess patients with chronic low back pain, but it has since been validated for various populations. It is a 17-item questionnaire where each item is scored on a 4-point Likert scale, ranging from "strongly disagree" to "strongly agree". While cut-off values can vary by population, a score higher than 37 is often considered to represent high kinesiofobia.
From enrollment to the 4 weeks after the implementation

Secondary Outcome Measures

Outcome Measure
Time Frame
2-Minute Walk Test
Time Frame: From enrollment to the 4 weeks after the implementation
From enrollment to the 4 weeks after the implementation
30 Seconds Sit to Stand Test (30STS)
Time Frame: From enrollment to the 4 weeks after the implementation
From enrollment to the 4 weeks after the implementation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2024

Primary Completion (Actual)

January 4, 2026

Study Completion (Estimated)

February 4, 2026

Study Registration Dates

First Submitted

January 30, 2026

First Submitted That Met QC Criteria

January 30, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25.01.2024/22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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