Physical Activity and Fatigue in Caregivers Before and After Liver Transplantation

NCT07468812 | Completed

• 1 other identifier: 2024-6657
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Transplantation

Keywords

Liver transplantation; caregiver; fatigue; physical activity; care burden

Outcome Measures

Primary Outcomes (3)

• Fatigue Severity Scale Total Score

  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.

  Pre-transplant period, postoperative day 90, and postoperative day 180

• Caregiver Burden (Zarit Burden Interview Total Score)

  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.

  Pre-transplant period, postoperative day 90, and postoperative day 180

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

  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.

  Pre-transplant period, postoperative day 90, and postoperative day 180

Study Arms (1)

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).

Other: Observational assessment of caregivers without any intervention.

Interventions

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).

Caregivers of Liver Transplant Recipients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consisted of informal caregivers of patients undergoing liver transplantation at the Liver Transplantation Institute Hospital of Inonu University. Caregivers were responsible for providing daily support and assistance to liver transplant recipients during the transplantation process. A total of 119 caregivers participated in the study and were evaluated at three time points: during the pre-transplant hospital period, at postoperative day 90, and at postoperative day 180.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hasan Kalyoncu University: lead

Study Sites (1)

Inonu University Turgut Ozal Medical Center

Malatya, 44090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fatigue; Motor Activity; Caregiver Burden

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Stress, Psychological; Behavioral Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 13, 2026
• Study Start: December 1, 2024
• Primary Completion: December 25, 2025
• Study Completion: February 3, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

TU (1)