- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07468812
Physical Activity and Fatigue in Caregivers Before and After Liver Transplantation
Investigation of Caregiver Physical Activity and Fatigue Levels 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Malatya, Turkey (Türkiye), 44090
- Inonu University Turgut Ozal Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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).
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Pre-transplant period, postoperative day 90, and postoperative day 180
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Caregiver Burden (Zarit Burden Interview Total Score)
Time Frame: Pre-transplant period, postoperative day 90, and postoperative day 180
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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.
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Pre-transplant period, postoperative day 90, and postoperative day 180
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Physical Activity Level (International Physical Activity Questionnaire-Short Form Total Score)
Time Frame: Pre-transplant period, postoperative day 90, and postoperative day 180
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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.
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Pre-transplant period, postoperative day 90, and postoperative day 180
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-6657
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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