NCT04031924

Brief Summary

Kinesiophobia and Physical Fitness, and Related Factors in Liver Transplantation

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 24, 2019

Completed
Last Updated

July 24, 2019

Status Verified

July 1, 2019

Enrollment Period

7 months

First QC Date

July 8, 2019

Last Update Submit

July 23, 2019

Conditions

Keywords

liver transplantationfunctional capacitykinesiophobiabalancephysical fitnessphysical activitymuscle strength

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • Physical Fitness

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

    5 minutes

  • Physical Fitness

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

    5 minutes

  • Physical Fitness

    The 8-Foot Up-and-Go test: This is measured in time (seconds) and reflects agility and dynamic balance.

    10 minutes

Secondary Outcomes (3)

  • Kinesiophobia

    15 minutes

  • Balance

    20 minutes

  • Balance

    15 minutes

Study Arms (2)

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

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

Interventions

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

Healthy SubjectsLiver Transplantation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • Hepatic encephalopathy
  • Progressive cardiac and/or pulmonary disease
  • Central nervous system pathologies
  • Orthopedic problems preventing physical assessments
  • Multiorgan transplantation
  • Cognitive deficits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

KinesiophobiaMotor Activity

Interventions

Physical Fitness

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Musculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHealthPopulation Characteristics

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical physiotherapist

Study Record Dates

First Submitted

July 8, 2019

First Posted

July 24, 2019

Study Start

December 20, 2017

Primary Completion

July 20, 2018

Study Completion

October 20, 2018

Last Updated

July 24, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations