Skip to content

Kinesiophobia, Quality of Life, and Cognitive Functions in Fibromyalgia Syndrome

Relationship Between Kinesiophobia, Quality of Life, and Cognitive Functions in Fibromyalgia Syndrome

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04695288
Enrollment
160
Registered
2021-01-05
Start date
2021-01-01
Completion date
2022-07-25
Last updated
2022-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Dysfunction, Fibromyalgia, Kinesiophobia

Keywords

Fibromyalgia, Kinesiophobia, Cognition, Quality of life

Brief summary

Although one of the most evidence-based treatment protocols is based on exercise strategies in patients with Fibromyalgia Syndrome, fear and avoidance of physical activity; named 'Kinesiophobia' may hinder the patients from the exercises. Cognitive dysfunctions are seen frequently in Fibromyalgia Syndrome. The aim of this study, to assess the relationship between kinesiophobia and cognitive functions, disease severity, quality of life, physical activity level, pain intensity, and anxiety/depression level in Fibromyalgia patients. Additionally, the investigators aimed to compare the kinesiophobia level and cognitive functions between patients with Fibromyalgia Syndrome and control subjects.

Detailed description

Cognitive dysfunction, including learning difficulties, memory, attention, and executive dysfunctions are frequent in fibromyalgia syndrome. Kinesiophobia is defined as fear and avoidance of physical activities, and it can lead to increased disability in patients with chronic pain. Although there is a relationship between cognitive functions and physical performance in Fibromyalgia Syndrome, the relationship between kinesiophobia, fibrofog, and quality of life are required to be investigated. The aims of this study are: 1. To compare the kinesiophobia and cognitive functions in Fibromyalgia Syndrome with healthy volunteers 2. To examine the relationship between the severity of kinesiophobia, cognitive functions, disease activity, quality of life, physical activity level, depression and anxiety severity in Fibromyalgia Syndrome. The hypothesis is, the patients diagnosed with Fibromyalgia Syndrome have higher kinesiophobia severity and worse cognitive functions, and also that kinesiophobia severity is associated with cognitive dysfunction, disease severity, physical activity level, and psychiatric symptoms in patients with Fibromyalgia Syndrome.

Interventions

None listed

Sponsors

Bozyaka Training and Research Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

-Fibromyalgia Syndrome

Exclusion criteria

* Education year \< 5 * Inflammatory rheumatic disease * Malignancy * Psychiatric disease * Alcohol/substance addiction * Central nervous system disease * History of head trauma * Chronic pain conditions other than Fibromyalgia Syndrome

Design outcomes

Primary

MeasureTime frameDescription
TAMPA Kinesiophobia Scale1 yearThe TAMPA Kinesiophobia Scale consists of 17 questions. Each question is scored between 1-4. The maximum score is 68, with high scores indicating an increased severity of kinesiophobia. A score of more than 37 indicates high severity of kinesiophobia.
Montreal Cognitive Assessment Test1 yearThis test evaluates eight separate cognitive functions: Attention, working memory, short-term memory, delayed memory, visuospatial abilities, executive functioning, language, and orientation to time and place. Scores of 21 and above are considered normal, with the highest test score being 30.

Secondary

MeasureTime frameDescription
Short Form-361 yearShort Form-36 (SF-36) is a widely used and validated scale for evaluating the quality of life. It is not specific to any disease group. It consists of thirty six items. It consists of 8 subscales related to physical health (physical function, physical role, pain, general health) and mental health (energy, social function, emotional role difficulty, mental health) factors. Each sub-scale chart is evaluated between 0 and 100 points. Higher scores indicate good health.
Visual Analogue scale1 yearThe patient is asked to mark her severity of pain on a horizontal 10-cm line with number 0 on one end representing no and number 10 on the other end indicating very severe pain. Higher scores indicate higher levels of pain intensity.
Hospital Anxiety/ Depression Questionnaire1 yearHospital Anxiety/ Depression Questionnaire determines the risk in terms of anxiety and depression in the patient and to measure its level and severity. It is used to diagnose anxiety and depression in a short time and determine the risk group for patients with physical diseases and those who apply to primary health care. Seven (odd numbers) of 14 questions measure anxiety and seven (even numbers) measure depression. Answers are scored in a four-point Likert scale between 0 and 3. The lowest score that patients can get from both subscales is 0, the highest score is 21.
International Physical Activity Questionnaire-Short Form1 yearPhysical activity levels in the last 7 (seven) days will be evaluated with the International Physical Activity Questionnaire-Short form. This short form consists of seven questions and provides information about the durations of physical activities, walking and sitting within the last seven days in the metabolic equivalent (MET)-min/week unit.
Fibromyalgia Impact Questionnaire1 yearIt aims to evaluate the arthritis symptoms and functional status of patients with fibromyalgia syndrome through 21 questions that inquire about physical functions, work-related situations, depression, anxiety, waking up tired, pain, stiffness, and fatigue. Higher scores indicate greater impact of fibromyalgia on functioning. Final score should range from 0 to 80.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026