- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04031924
Kinesiophobia and Physical Fitness, and Related Factors in Liver Transplantation
July 23, 2019 updated by: Bilge Taskin, Hacettepe University
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
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
32
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ankara, Turkey
- Hacettepe University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Hepatic encephalopathy
- Progressive cardiac and/or pulmonary disease
- Central nervous system pathologies
- Orthopedic problems preventing physical assessments
- Multiorgan transplantation
- Cognitive deficits
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
All liver transplantation patients who underwent transplant at least one year ago and healthy subjects were evaluated the first day they came.
|
Healthy Subjects
Sixteen age- and sex-matched healthy subjects were included in the study.
|
All liver transplantation patients who underwent transplant at least one year ago and healthy subjects were evaluated the first day they came.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
10 minutes
|
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.
|
10 minutes
|
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.
|
30 minutes
|
Physical Fitness
Time Frame: 5 minutes
|
The Chair Sit and Reach Test: This is measured in distance (cm) and reflects lower body flexibility.
|
5 minutes
|
Physical Fitness
Time Frame: 5 minutes
|
The Back Scratch Test: This is measured in distance (cm) and reflects upper body flexibility.
|
5 minutes
|
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.
|
10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Kinesiophobia
Time Frame: 15 minutes
|
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.
|
15 minutes
|
Balance
Time Frame: 20 minutes
|
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.
|
20 minutes
|
Balance
Time Frame: 15 minutes
|
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.
|
15 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 20, 2017
Primary Completion (Actual)
July 20, 2018
Study Completion (Actual)
October 20, 2018
Study Registration Dates
First Submitted
July 8, 2019
First Submitted That Met QC Criteria
July 23, 2019
First Posted (Actual)
July 24, 2019
Study Record Updates
Last Update Posted (Actual)
July 24, 2019
Last Update Submitted That Met QC Criteria
July 23, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NACIYEVARDAR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Liver Transplant Disorder
-
Min Suk ChaeNot yet recruitingLiver Transplant Disorder
-
Vinmec Healthcare SystemTerminatedLiver Transplant DisorderVietnam
-
Asan Medical CenterCompletedLiver Transplant DisorderKorea, Republic of
-
Chang Gung Memorial HospitalNot yet recruitingLiver Transplant Disorder
-
University Hospital, Strasbourg, FranceCompletedLiver Transplant DisorderFrance
-
Vinmec Healthcare SystemTerminatedLiver Transplant DisorderVietnam
-
Paragonix TechnologiesEnrolling by invitationLiver Diseases | Liver Transplant Disorder | Liver Dysfunction | Liver Transplant RejectionUnited States
-
RenJi HospitalNot yet recruitingHBV | Liver Transplant Disorder
-
Maksude YILDIRIMInonu UniversityCompletedSleep | Liver Transplant DisorderTurkey
-
University of BolognaUniversity of Pisa; Azienda Ospedaliera Città della Salute e della Scienza... and other collaboratorsCompletedHCC | Liver Transplant Disorder
Clinical Trials on Assessment of: 1. Functional Capacity 2. Physical Fitness 3. Physical Activity Level 4. Balance 5. Kinesiophobia 6. Psychological Status 7. Fatigue Severity
-
Memorial Sloan Kettering Cancer CenterUniversity of Texas Southwestern Medical Center; Wake Forest UniversityActive, not recruitingBreast CancerUnited States
-
Hacettepe UniversityCompletedQuality of Life | Physical Disability | Psychosocial Problem | Meniere DiseaseTurkey