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Completed

NCT Number: NCT04031924

Kinesiophobia and Physical Fitness, and Related Factors in Liver Transplantation

Kinesiophobia and Physical Fitness, and Related Factors in Liver Transplantation

Completed

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacettepe University

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Assessment of: 1. Functional Capacity 2. Physical Fitness 3. Physical Activity Level 4. Balance 5. Kinesiophobia 6. Psychological Status 7. Fatigue Severity

Other

All liver transplantation patients who underwent transplant at least one year ago and healthy subjects were evaluated the first day they came.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Physical Fitness

    Time frame: 5 minutes

    The Chair Sit and Reach Test: This is measured in distance (cm) and reflects lower body flexibility.

  5. Physical Fitness

    Time frame: 5 minutes

    The Back Scratch Test: This is measured in distance (cm) and reflects upper body flexibility.

  6. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 24, 2019
Registry last updated
Jul 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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