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

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.

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

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

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

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