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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Turkey
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Assessment of: 1. Functional Capacity 2. Physical Fitness 3. Physical Activity Level 4. Balance 5. Kinesiophobia 6. Psychological Status 7. Fatigue Severity
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.
Other: Assessment of: 1. Functional Capacity 2. Physical Fitness 3. Physical Activity Level 4. Balance 5. Kinesiophobia 6. Psychological Status 7. Fatigue Severity
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 20, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 20, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 24, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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