NCT03875040

Brief Summary

Although the importance of regular physical activity in patients with knee osteoarthritis is known, and fear of movement is considered as one of the causes of physical inactivity and is widely researched in terms of its role in the pathogenesis of pain, there remains to be limited number of studies on kinesiophobia in these patients. In this study, we aimed to evaluate the levels of kinesiophobia and physical activity in patients with knee osteoarthritis and to investigate whether they were associated with demographic characteristics, body mass index, pain intensity, depression, disability, radiological grade, and quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2018

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

April 20, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 14, 2019

Completed
Last Updated

March 22, 2019

Status Verified

March 1, 2019

Enrollment Period

6 months

First QC Date

March 13, 2019

Last Update Submit

March 20, 2019

Conditions

Keywords

kinesiophobiaosteoarthritisfear of movementtampaphysical inactivity

Outcome Measures

Primary Outcomes (6)

  • Tampa Scale of Kinesiophobia

    Based on a four-point Likert type, this scale contains 17 items that evaluate fear and anxiety related to physical activity. A total score of greater than 37 is accepted as statistically significant and interpreted as a high level of kinesiophobia. Minimal and maximal scores could be between 17-68 points. Higher scores indicate higher levels of kinesiophobia.

    4-8 minutes

  • International Physical Activity Questionnaire Short Form

    This questionnaire consists of seven items that measure the duration of the participants' physical activity, walking and sitting within the last seven days in the metabolic equivalent (MET)-min/week unit. 3 or more days of vigorous activity of at least 20 minutes per day or 5 or more days of moderate-intensity activity and/or walking of at least 30 minutes per day or 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 600 MET-minutes/week are proposed to be moderate level. Vigorous-intensity activity on at least 3 days and accumulating at least 1500 MET-minutes/week or 7 or more days of any combination of walking, moderate- or vigorous-intensity activities accumulating at least 3000 MET-minutes/week are proposed to be high level.Some activity is reported but not enough to meet categories of moderate or high levels, it is proposed to be low level.

    5-10 minutes

  • Beck Depression Inventory

    This is a 21-item questionnaire that investigates the characteristic attitudes and symptoms of depression. A score of 10 or higher indicates depression. Minimal and maximal scores can be 0-63 points. Higher scores indicate higher levels of depression.

    10 minutes

  • Visual Analog Scale for the Evaluation of Pain

    For this evaluation, the patient is asked to mark his/her severity of pain on a horizontal 10-cm line with number 0 on one end representing "no pain" and number 10 on the other end indicating "very severe pain". Higher scores indicate higher levels of pain intensity.

    0.5 minutes

  • Short Form-12 Health Survey Questionnaire

    A scale used to evaluate the quality of life, consisting of 12 items inquiring general health, physical condition, physical limitations, mental status, social status, pain, energy and mental limitation over a total score of 100 points. SF-12 is an abbreviated version of SF-36 and has been proven to be reliable and valid. In this study, we evaluated the patients' total, physical and mental SF-12 scores

    5 minutes

  • Western Ontario and McMaster Universities Arthritis Index

    A 24-item measure that was developed to evaluate pain, joint stiffness and physical functions in individuals with knee and hip OA. A higher score indicates a higher level of pain, stiffness and functional limitation. In our study, we used the WOMAC total score.

    10 minutes

Interventions

kinesiophobiaBEHAVIORAL

patients who have a high-level or low-level kinesiophobia have been evaluated.

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All the patients presenting to Aksaray Training and Research Hospital Physical Medicine and Rehabilitation Outpatient Clinic between April 2018 and October 2018, who volunteered to participate in the study and fulfilled the inclusion criteria, completed the questionnaire forms.

You may qualify if:

  • knee osteoarthritis aged 50 to 75 years knee pain lasting for than three months knee pain intensity over 20 mm on Visual Analog Scale-VAS

You may not qualify if:

  • knee operation, Malignant diseases Systemic infectious diseases inflammatory diseases Fibromyalgia syndrome physical therapy and/or a knee injection within the last three months antidepressants, pregabalin or duloxetine usage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aksaray Training and Research Hospital

Aksaray, Merkez, 68200, Turkey (Türkiye)

Location

Related Publications (2)

  • Gunn AH, Schwartz TA, Arbeeva LS, Callahan LF, Golightly Y, Goode A, Hill CH, Huffman K, Iversen MD, Pathak A, Taylor SS, Allen KD. Fear of Movement and Associated Factors Among Adults With Symptomatic Knee Osteoarthritis. Arthritis Care Res (Hoboken). 2017 Dec;69(12):1826-1833. doi: 10.1002/acr.23226. Epub 2017 Nov 6.

    PMID: 28371481BACKGROUND
  • Shelby RA, Somers TJ, Keefe FJ, DeVellis BM, Patterson C, Renner JB, Jordan JM. Brief Fear of Movement Scale for osteoarthritis. Arthritis Care Res (Hoboken). 2012 Jun;64(6):862-71. doi: 10.1002/acr.21626. Epub 2012 Jan 30.

    PMID: 22290689BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, KneeMotor ActivityKinesiophobiaOsteoarthritisSedentary Behavior

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehaviorPhobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Melek Aykut Selçuk

    Ankara Akyurt Public Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 13, 2019

First Posted

March 14, 2019

Study Start

April 20, 2018

Primary Completion

October 20, 2018

Study Completion

October 20, 2018

Last Updated

March 22, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations