RecruitingNot ApplicableNCT07394621

Kinesiophobia in Patients With Implanted Left Ventricular Assist Devices

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


Sponsor

Marmara University

Enrollment

37 participants

Start Date

Dec 2, 2024

Study Type

INTERVENTIONAL

Conditions

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

Plain Language Summary

Simplified for easier understanding

This study is examining kinesiophobia — the fear of movement due to concern about re-injury — in patients who have had a left ventricular assist device (LVAD) implanted. An LVAD is a mechanical pump that helps a failing heart pump blood. This study uses questionnaires to understand how fear of movement affects recovery and physical activity in LVAD patients. **You may be eligible if...** - You are a heart transplant candidate who has had an LVAD implanted - Your heart's pumping function is severely reduced (ejection fraction below 30%) - You did not have any major complications early after surgery - You were referred to the study by a cardiologist at the time of hospital discharge - You can read and write **You may NOT be eligible if...** - You have signs of active infection after the surgery - You developed psychiatric problems after LVAD implantation that affect your thinking - You developed musculoskeletal problems after LVAD implantation - You were hospitalized for acute heart problems during follow-up Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTPhysical Activity Recommandations

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


Locations(1)

Marmara University Faculty of Health Sciences

Istanbul, Turkey (Türkiye)

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NCT07394621


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