Kinesiophobia Affects Functional Capacity in Patients With Implanted Left Ventricular Assist Devices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Tampa Kinesiophobia Scale
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Exercise Recommendation Group
Patient who recevied physical activity recommendations after LVAD implementation
干预措施: Physical Activity Recommandations (Diagnostic Test)
结局指标
主要结局
Tampa Kinesiophobia Scale
时间窗: 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.
次要结局
- 2-Minute Walk Test(From enrollment to the 4 weeks after the implementation)
- 30 Seconds Sit to Stand Test (30STS)(From enrollment to the 4 weeks after the implementation)
研究者
Rafet Umut Erdoğan
Research Assistant
Marmara University