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NCT Number: NCT07468812

Physical Activity and Fatigue in Caregivers Before and After Liver Transplantation

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Inonu University Turgut Ozal Medical Center

Malatya, 44090, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Observational assessment of caregivers without any intervention.

Other

This study did not include any therapeutic intervention. It was an observational study in which caregivers of liver transplant recipients were evaluated at different time points. Fatigue severity, caregiver burden, and physical activity levels were assessed using standardized questionnaires including the Fatigue Severity Scale (FSS), Zarit Burden Interview (ZBI), and the International Physical Activity Questionnaire-Short Form (IPAQ-SF).

Primary outcomes

  1. Fatigue Severity Scale Total Score

    Time frame: 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.

  2. Caregiver Burden (Zarit Burden Interview Total Score)

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hasan Kalyoncu University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 13, 2026
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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