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Completed

NCT Number: NCT03875040

Knee Osteoarthritis, Kinesiophobia and Physical Activity

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.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aksaray Training and Research Hospital

Aksaray, Merkez, 68200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

kinesiophobia

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.

Sponsors and collaborators

Lead sponsor

Aksaray University Training and Research Hospital

Other

Registry information

Official study title

Is There a Relationship Between Kinesiophobia and Physical Activity Level in Patients With Knee Osteoarthritis?

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 14, 2019
Registry last updated
Mar 22, 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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