Liver TransplantationNCT07468812
Physical Activity and Fatigue in Caregivers Before and After Liver Transplantation
An observational study of Liver Transplantation, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Observational assessment of caregivers without any intervention.
- How many people
- 119 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 3 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Inonu University Turgut Ozal Medical Center
Malatya, 44090
About this study
Official title: 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.
Read the 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.
- Conditions
- Liver Transplantation
- Being tested
- Observational assessment of caregivers without any intervention.
- Keywords
- Liver transplantation, caregiver, fatigue, physical activity, care burden
- Medical subject headings
- Fatigue, Motor Activity, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Observational assessment of caregivers without any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Pre-transplant period, postoperative day 90, and postoperative day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 Dec 2024
- Primary completion25 Dec 2025
- Study completion3 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlker DEMİR, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468812
- Sponsor's protocol ID
- 2024-6657
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It has not yet been determined whether individual participant data will be shared. Data sharing will be considered upon reasonable request and in accordance with institutional policies and ethical regulations.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Caregiver Physical Activity and Fatigue Levels Before and After Liver Transplantation
- ClinicalTrials.gov ID
- NCT07468812
- Acronym / sponsor ID
- 2024-6657
- Conditions
- Liver Transplantation
- Keywords
- Liver transplantation, caregiver, fatigue, physical activity, care burden
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 25 Dec 2025 (actual)
- Study completion
- 3 Feb 2026 (actual)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caregivers of Liver Transplant Recipients | – | Other: Observational assessment of caregivers without any intervention.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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational assessment of caregivers without any intervention.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). | Other | Caregivers of Liver Transplant Recipients |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: Undecided. It has not yet been determined whether individual participant data will be shared. Data sharing will be considered upon reasonable request and in accordance with institutional policies and ethical regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplantation, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Severity Scale Total Score (time frame: Pre-transplant period, postoperative day 90, and postoperative day 180). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.