Clinical Trial

Kinesiophobia in Patients With Implanted Left Ventricular Assist Devices

Completed
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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.
Protocol Amendment History 3 changes
critical Trial completed 2026-08-14
notable Primary completion pushed: 2026-01-04 -> 2026-06-15 2026-08-14
minor Completion pushed: 2026-02-04 -> 2026-07-15 2026-08-14
Trial Details
NCT Number NCT07394621
Lead Sponsor Marmara University
Conditions Kinesiophobia (Fear of Movement)
Enrollment 37 participants
Start Date 2026-01-02
Primary Completion 2026-06-15 (estimated)
Study Completion 2026-07-15 (estimated)
Updated on ClinicalTrials.gov 2026-08-13