Kinesiophobia and Physical Fitness, and Related Factors in Liver Transplantation

Liver Transplant Disorder Clinical Trial

Official title:

An Evaluation of Balance, Functional Capacity, Kinesiophobia and Physical Fitness in Patients With Liver Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04031924
• Other study ID #: NACIYEVARDAR
• Status: Completed
• Start date: December 20, 2017
• Est. completion date: October 20, 2018

Study information

• Verified date: July 2019
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Kinesiophobia and Physical Fitness, and Related Factors in Liver Transplantation

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 20, 2018
• Est. primary completion date: July 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Transplant Disorder

Intervention

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.

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 minutes
Primary	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.	10 minutes
Primary	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.	30 minutes
Primary	Physical Fitness	The Chair Sit and Reach Test: This is measured in distance (cm) and reflects lower body flexibility.	5 minutes
Primary	Physical Fitness	The Back Scratch Test: This is measured in distance (cm) and reflects upper body flexibility.	5 minutes
Primary	Physical Fitness	The 8-Foot Up-and-Go test: This is measured in time (seconds) and reflects agility and dynamic balance.	10 minutes
Secondary	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.	15 minutes
Secondary	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.	20 minutes
Secondary	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.	15 minutes