NCT07394621 Kinesiophobia in Patients With Implanted Left Ventricular Assist Devices
| NCT ID | NCT07394621 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Marmara University |
| Condition | Kinesiophobia (Fear of Movement) |
| Study Type | INTERVENTIONAL |
| Enrollment | 37 participants |
| Start Date | 2024-12-02 |
| Primary Completion | 2026-01-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 37 participants in total. It began in 2024-12-02 with a primary completion date of 2026-01-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07394621 clinical trial?
This trial is open to participants of all sexes, studying Kinesiophobia (Fear of Movement). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07394621 currently recruiting?
Yes, NCT07394621 is actively recruiting participants. Contact the research team at rafetumuterdogan@gmail.com for enrollment information.
Where is the NCT07394621 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT07394621 clinical trial?
NCT07394621 is sponsored by Marmara University. The trial plans to enroll 37 participants.