Liver Transplant DisorderNCT04031924
Kinesiophobia and Physical Fitness, and Related Factors in Liver Transplantation
An observational study of Liver Transplant Disorder, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Kinesiophobia and Physical Fitness, and Related Factors in Liver Transplantation Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Transplant Disorder
- What is being tested?
- Assessment of: 1. Functional Capacity 2. Physical Fitness 3. Physical Activity Level 4. Balance 5. Kinesiophobia 6. Psychological Status 7. Fatigue Severity
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2017to 20 Oct 2018
- How long will I take part?
- 2 Days
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Sixteen individuals older than 18 years of age who had undergone liver transplantation at Hacettepe University Hospital at least one year ago and 16 age- and sex-matched healthy subjects were included in the study
Who may be able to join
- All patients older than 18 years of age who had undergone liver transplantation at Hacettepe University Hospital at least one year ago were eligible for the study.
Who cannot join
- Hepatic encephalopathy
- Progressive cardiac and/or pulmonary disease
- Central nervous system pathologies
- Orthopedic problems preventing physical assessments
- Multiorgan transplantation
- Cognitive deficits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Evaluation of Balance, Functional Capacity, Kinesiophobia and Physical Fitness in Patients With Liver Transplantation
Kinesiophobia and Physical Fitness, and Related Factors in Liver Transplantation
- Conditions
- Liver Transplant Disorder
- Being tested
- Assessment of: 1. Functional Capacity 2. Physical Fitness 3. Physical Activity Level 4. Balance 5. Kinesiophobia 6. Psychological Status 7. Fatigue Severity
- Keywords
- liver transplantation, functional capacity, kinesiophobia, balance, physical fitness, physical activity, muscle strength
- Medical subject headings
- Kinesiophobia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of: 1. Functional Capacity 2. Physical Fitness 3. Physical Activity Level 4. Balance 5. Kinesiophobia 6. Psychological Status 7. Fatigue SeverityOther
All liver transplantation patients who underwent transplant at least one year ago and healthy subjects were evaluated the first day they came.
| Study group | Role | What they receive |
|---|---|---|
| Liver Transplantation | Sixteen individuals with liver transplantation were included in the study, and their physical and demographic characteristics of the individuals recorded. The Senior Fitness Test (SFT) was used to evaluate to physical fitness. The Tampa Scale for Kinesiophobia (TSK) was used to assess kinesiophobia; the Fatigue Impact Scale (FIS) and Fatigue Severity Scale (FSS) to evaluate fatigue; the Berg Balance Scale (BBS) and the Timed Up and Go test (TUG) to evaluate the balance; the International Physical Activity Questionnaire (IPAQ) to determine the level of physical activity;and the Hospital Anxiety and Depression Scale (HADS) to evaluate psychological status. Receives: Other: Assessment of: 1. Functional Capacity 2. Physical Fitness 3. Physical Activity Level 4. Balance 5. Kinesiophobia 6. Psychological Status 7. Fatigue Severity | |
| Healthy Subjects | Sixteen age- and sex-matched healthy subjects were included in the study. Receives: Other: Assessment of: 1. Functional Capacity 2. Physical Fitness 3. Physical Activity Level 4. Balance 5. Kinesiophobia 6. Psychological Status 7. Fatigue Severity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Fitness
The Chair Stand Test: This requires people to repeatedly stand up from and sit down on a chair for 30 seconds. The number of stands is recorded.
Measured: 10 minutes
Physical Fitness
The Biceps Curl Test: This requires people to repeatedly lift a 5 lb(2.27 kg) weight (for women) or an 8 lb (3.63 kg) weight (for men) for 30 seconds. The number of lifts is recorded.
Measured: 10 minutes
Physical Fitness
The 6-minute Walk Test: This is measured in distance (m) and reflects aerobic endurance. The original version of the Senior Fitness Test required people to walk on a straight line.
Measured: 30 minutes
Physical Fitness
The Chair Sit and Reach Test: This is measured in distance (cm) and reflects lower body flexibility.
Measured: 5 minutes
Physical Fitness
The Back Scratch Test: This is measured in distance (cm) and reflects upper body flexibility.
Measured: 5 minutes
Physical Fitness
The 8-Foot Up-and-Go test: This is measured in time (seconds) and reflects agility and dynamic balance.
Measured: 10 minutes
Secondary outcomes (3)
Kinesiophobia
Kinesiophobia was assessed in all participants using the Tampa Scale of Kinesiophobia (TSK). The TSK is a self-completed questionnaire and the range of scores are from 17 to 68 where the higher scores indicate an increasing degree of kinesiophobia.
Measured: 15 minutes
Balance
Berg Balance Scale (BBS) was used to evaluate balance. The BBS consists of 14 items which include simple mobility task and that are scored on a scale of 0 to 4. The level of proficiency for each activity, a score of "0" is given if the participant is unable to do the task and a score of "4" is given if the participant can complete the task based on the criterion that has been assigned to it. The maximum total score on the test is 56.
Measured: 20 minutes
Balance
The Timed Up and Go Test was used to assess the balance performance of people during the movement. For the starter position, a participant sits in a chair with standard height, measuring a distance of 3 meters from the chair. The test timer starts by the clinician at the moment the clinician said "go", the participant gets up from a chair, walks 3 meters, turns 180° a designed spot, walks back to the seat, when the participant sits down then the test stopped.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start20 Dec 2017
- Primary completion20 Jul 2018
- Study completion20 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant DisorderStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilge Taskin, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04031924
- Sponsor's protocol ID
- NACIYEVARDAR
- Status last verified
- Jul 2019
- First submitted
- 8 Jul 2019
- Last updated
- 24 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Balance, Functional Capacity, Kinesiophobia and Physical Fitness in Patients With Liver Transplantation
- ClinicalTrials.gov ID
- NCT04031924
- Acronym / sponsor ID
- NACIYEVARDAR
- Conditions
- Liver Transplant Disorder
- Keywords
- liver transplantation, functional capacity, kinesiophobia, balance, physical fitness, physical activity, muscle strength
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 20 Jul 2018 (actual)
- Study completion
- 20 Oct 2018 (actual)
- First posted
- 24 Jul 2019 (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.
Kinesiophobia and Physical Fitness, and Related Factors in Liver Transplantation
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liver Transplantation | – | Other: Assessment of: 1. Functional Capacity 2. Physical Fitness 3. Physical Activity Level 4. Balance 5. Kinesiophobia 6. Psychological Status 7. Fatigue SeveritySixteen individuals with liver transplantation were included in the study, and their physical and demographic characteristics of the individuals recorded. The Senior Fitness Test (SFT) was used to evaluate to physical fitness. The Tampa Scale for Kinesiophobia (TSK) was used to assess kinesiophobia; the Fatigue Impact Scale (FIS) and Fatigue Severity Scale (FSS) to evaluate fatigue; the Berg Balance Scale (BBS) and the Timed Up and Go test (TUG) to evaluate the balance; the International Physical Activity Questionnaire (IPAQ) to determine the level of physical activity;and the Hospital Anxiety and Depression Scale (HADS) to evaluate psychological status. |
| Healthy Subjects | – | Other: Assessment of: 1. Functional Capacity 2. Physical Fitness 3. Physical Activity Level 4. Balance 5. Kinesiophobia 6. Psychological Status 7. Fatigue SeveritySixteen age- and sex-matched healthy subjects were included in the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Sixteen individuals older than 18 years of age who had undergone liver transplantation at Hacettepe University Hospital at least one year ago and 16 age- and sex-matched healthy subjects were included in the study
Key inclusion criteria (1 listed)
- All patients older than 18 years of age who had undergone liver transplantation at Hacettepe University Hospital at least one year ago were eligible for the study.
Key exclusion criteria (6 listed)
- Hepatic encephalopathy
- Progressive cardiac and/or pulmonary disease
- Central nervous system pathologies
- Orthopedic problems preventing physical assessments
- Multiorgan transplantation
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 |
|---|---|---|
| Assessment of: 1. Functional Capacity 2. Physical Fitness 3. Physical Activity Level 4. Balance 5. Kinesiophobia 6. Psychological Status 7. Fatigue SeverityAll liver transplantation patients who underwent transplant at least one year ago and healthy subjects were evaluated the first day they came. | Other | Healthy Subjects, Liver Transplantation |
Primary outcome
Physical Fitness
Time frame: 10 minutes
The Chair Stand Test: This requires people to repeatedly stand up from and sit down on a chair for 30 seconds. The number of stands is recorded.
Physical Fitness
Time frame: 10 minutes
The Biceps Curl Test: This requires people to repeatedly lift a 5 lb(2.27 kg) weight (for women) or an 8 lb (3.63 kg) weight (for men) for 30 seconds. The number of lifts is recorded.
Physical Fitness
Time frame: 30 minutes
The 6-minute Walk Test: This is measured in distance (m) and reflects aerobic endurance. The original version of the Senior Fitness Test required people to walk on a straight line.
Physical Fitness
Time frame: 5 minutes
The Chair Sit and Reach Test: This is measured in distance (cm) and reflects lower body flexibility.
Physical Fitness
Time frame: 5 minutes
The Back Scratch Test: This is measured in distance (cm) and reflects upper body flexibility.
Physical Fitness
Time frame: 10 minutes
The 8-Foot Up-and-Go test: This is measured in time (seconds) and reflects agility and dynamic balance.
3 secondary outcomes
Kinesiophobia
Time frame: 15 minutes
Balance
Time frame: 20 minutes
Balance
Time frame: 15 minutes
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 24 Jul 2019.
- Individual participant dataSharing planned: No
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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 Transplant Disorder, run by Hacettepe 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 1 inclusion and 6 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 24 Jul 2019. 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?
Physical Fitness (time frame: 10 minutes). The study lists 6 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 24 Jul 2019.