Marmara University Faculty of Health Sciences
Istanbul, 34854, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07394621
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.
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Interventional
Not applicable
Istanbul, 34854, Turkey (Türkiye)
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
Time frame: From enrollment to the 4 weeks after the implementation
Time frame: From enrollment to the 4 weeks after the implementation
Contact information is provided by the study sponsor or research team.
Marmara University
Other
Kinesiophobia Affects Functional Capacity in Patients With Implanted Left Ventricular Assist Devices
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