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临床试验/NCT07468812
NCT07468812
已完成
不适用

Investigation of Caregiver Physical Activity and Fatigue Levels Before and After Liver Transplantation

Hasan Kalyoncu University1 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2024年12月1日最近更新:

概览

阶段
不适用
状态
已完成
发起方
Hasan Kalyoncu University
入组人数
119
试验地点
1
主要终点
Fatigue Severity Scale Total Score

概览

简要总结

Caregivers of liver transplant recipients often experience substantial physical and psychological demands during the transplantation process. These responsibilities may influence caregivers' fatigue levels, caregiving burden, and physical activity patterns. Understanding these changes is important for protecting caregivers' health and supporting the long-term care process.

The aim of this study was to examine changes in fatigue severity, caregiver burden, and physical activity levels among caregivers of liver transplant recipients before and after liver transplantation. A total of 119 caregivers participated in the study. Assessments were conducted at three time points: during the pre-transplant hospital phase, at 90 days after transplantation, and at 180 days after transplantation.

Fatigue severity was measured using the Fatigue Severity Scale, caregiver burden was assessed using the Zarit Burden Interview, and physical activity levels were evaluated using the International Physical Activity Questionnaire-Short Form. The findings of this study aim to provide insight into the changes experienced by caregivers during the transplantation process and to contribute to the development of strategies that support caregiver well-being.

详细描述

Liver transplantation is an effective treatment for patients with end-stage liver disease and significantly improves survival and quality of life. However, the transplantation process not only affects recipients but also places considerable physical and psychological demands on caregivers. Caregivers are responsible for assisting patients with daily activities, monitoring medical treatments, and supporting the recovery process. These responsibilities may lead to increased fatigue, caregiver burden, and changes in physical activity patterns.

Although previous studies have examined caregiver burden and fatigue in different chronic diseases, limited research has investigated these parameters among caregivers of liver transplant recipients, particularly during different stages of the transplantation process. Understanding these changes is important for protecting caregiver health and improving long-term care outcomes for transplant recipients.

The present study aimed to investigate changes in fatigue severity, caregiver burden, and physical activity levels among caregivers of liver transplant recipients before and after liver transplantation. The study was conducted at the Liver Transplantation Institute Hospital of Inonu University between December 2024 and February 2026. Caregivers responsible for the care of patients undergoing liver transplantation were included in the study.

Data were collected at three different time points: during the pre-transplant hospital period, at postoperative day 90, and at postoperative day 180. Fatigue severity was evaluated using the Fatigue Severity Scale (FSS), caregiver burden was assessed using the Zarit Burden Interview (ZBI), and physical activity levels were measured using the International Physical Activity Questionnaire-Short Form (IPAQ-SF).

The study was designed to evaluate how caregiver fatigue, caregiving burden, and physical activity levels change over time during the transplantation process and to identify factors associated with these outcomes. The findings may help improve awareness of caregiver health and contribute to the development of supportive strategies for caregivers involved in the liver transplantation process.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being responsible for the care of a patient undergoing liver transplantation,
  • Being between 18 and 65 years of age,
  • Having sufficient literacy to understand the purpose of the study and the forms to be completed.

排除标准

  • Not being accepted into the study,
  • Having a limitation or comorbid condition that would interfere with the tests,
  • Having taken a break from caregiving for a certain period of time.

研究组 & 干预措施

Caregivers of Liver Transplant Recipients

This cohort consisted of informal caregivers of patients undergoing liver transplantation. Caregivers were responsible for providing daily support to liver transplant recipients during the transplantation process. Participants were evaluated at three different time points: during the pre-transplant hospital period, at postoperative day 90, and at postoperative day 180. Fatigue severity, caregiver burden, and physical activity levels were assessed using the Fatigue Severity Scale (FSS), Zarit Burden Interview (ZBI), and the International Physical Activity Questionnaire-Short Form (IPAQ-SF).

干预措施: Observational assessment of caregivers without any intervention. (Other)

结局指标

主要结局

Fatigue Severity Scale Total Score

时间窗: Pre-transplant period, postoperative day 90, and postoperative day 180

Fatigue severity will be assessed using the Fatigue Severity Scale (FSS). The scale consists of 9 items scored from 1 to 7. Total scores range from 9 to 63, with higher scores indicating greater fatigue severity.

Caregiver Burden (Zarit Burden Interview Total Score)

时间窗: Pre-transplant period, postoperative day 90, and postoperative day 180

Caregiver burden will be assessed using the Zarit Burden Interview (ZBI). The scale consists of 22 items scored on a 5-point Likert scale ranging from 0 to 4. Total scores range from 0 to 88, with higher scores indicating greater caregiver burden.

Physical Activity Level (International Physical Activity Questionnaire-Short Form Total Score)

时间窗: Pre-transplant period, postoperative day 90, and postoperative day 180

Physical activity levels will be assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). The questionnaire evaluates the frequency and duration of walking, moderate-intensity, and vigorous-intensity physical activities performed during the last seven days. Participants are classified into physical activity categories according to standard IPAQ scoring procedures.

次要结局

未报告次要终点

研究者

发起方
Hasan Kalyoncu University
申办方类型
Other
责任方
Principal Investigator
主要研究者

İlker DEMİR

Principal Investigator

Inonu University

研究点 (1)

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