Kinesiophobia in Patients With Implanted Left Ventricular Assist Devices
ConditionKinesiophobia (Fear of Movement)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorMarmara University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Physical Activity Recommandations
Diagnostic testPatients with implanted LVADs will be given recommendations for physical activities they can incorporate into their daily lives.
Treatment groups
37 Participants
are divided into 1 treatment groupGroup A: Exercise Recommendation GroupExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
From enrollment to the 4 weeks after the implementationSecondary outcomes
1
2-Minute Walk Test
Time frame
From enrollment to the 4 weeks after the implementation2
30 Seconds Sit to Stand Test (30STS)
Time frame
From enrollment to the 4 weeks after the implementationSponsors and contacts
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Source ClinicalTrials.gov