- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03875040
Knee Osteoarthritis, Kinesiophobia and Physical Activity
March 20, 2019 updated by: Dr. Melek Aykut Selçuk, Aksaray University Training and Research Hospital
Is There a Relationship Between Kinesiophobia and Physical Activity Level in Patients With Knee Osteoarthritis?
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A total of 96 female and male patients aged 50 to 75 years with knee osteoarthritis (OA) and knee pain lasting for more than three months (knee pain intensity over 20 mm on Visual Analog Scale-VAS) were included in the study.
The severity of pain at night, pain at rest and activity-related pain was evaluated by Visual Analog Scale (VAS), kinesiophobia by Tampa Scale of Kinesiophobia (TSK) and Brief Fear of Movement Scale (BFOM), depression by the Beck Depression Inventory (BDI), disability by the Western Ontario and McMaster Universities Arthritis Index (WOMAC), physical activity level by the International Physical Activity Questionnaire (IPAQ) short form and quality of life by the Short Form 12 Health Survey Questionnaire (SF-12).
Age, gender, marital status, educational status, additional disease, drug history, and sociodemographic data such as BMI were obtained from the patients and recorded in the evaluation form.
Study Type
Observational
Enrollment (Actual)
96
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
-
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Merkez
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Aksaray, Merkez, Turkey, 68200
- Aksaray Training and Research Hospital
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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
Ages Eligible for Study
50 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability 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.
Description
Inclusion Criteria:
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
Exclusion Criteria:
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
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
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Beck Depression Inventory
Time Frame: 10 minutes
|
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
|
|
Tampa Scale of Kinesiophobia
Time Frame: 4-8 minutes
|
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
Time Frame: 5-10 minutes
|
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
|
|
Visual Analog Scale for the Evaluation of Pain
Time Frame: 0.5 minutes
|
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
Time Frame: 5 minutes
|
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
Time Frame: 10 minutes
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Melek Aykut Selçuk, Ankara Akyurt Public Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
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)
April 20, 2018
Primary Completion (Actual)
October 20, 2018
Study Completion (Actual)
October 20, 2018
Study Registration Dates
First Submitted
March 13, 2019
First Submitted That Met QC Criteria
March 13, 2019
First Posted (Actual)
March 14, 2019
Study Record Updates
Last Update Posted (Actual)
March 22, 2019
Last Update Submitted That Met QC Criteria
March 20, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018/67
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
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