Kinesiophobia in Patients With Implanted Left Ventricular Assist Devices

NCT07394621 | Recruiting

• 1 other identifier: 25.01.2024/22
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kinesiophobia (Fear of Movement)

Keywords

kinesiophobia; functional capacity; LVAD

Outcome Measures

Primary Outcomes (1)

• Tampa Kinesiophobia Scale

  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 Outcomes (2)

• 2-Minute Walk Test

  From enrollment to the 4 weeks after the implementation

• 30 Seconds Sit to Stand Test (30STS)

  From enrollment to the 4 weeks after the implementation

Study Arms (1)

Exercise Recommendation Group

EXPERIMENTAL

Patient who recevied physical activity recommendations after LVAD implementation

Diagnostic Test: Physical Activity Recommandations

Interventions

Physical Activity Recommandations DIAGNOSTIC_TEST

Patients with implanted LVADs will be given recommendations for physical activities they can incorporate into their daily lives.

Also known as: 30 seconds sit to stand test, 2 minute walk test

Exercise Recommendation Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Faculty of Health Sciences

Istanbul, 34854, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Kinesiophobia

Interventions

Walk Test

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Exercise Test; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Rafet Umut Erdoğan

CONTACT

+905542398786; rafetumuterdogan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 6, 2026
• Study Start: December 2, 2024
• Primary Completion: January 4, 2026
• Study Completion: February 4, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)