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Clinical Trials/NCT04695288
NCT04695288CompletedNot Applicable

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

Bozyaka Training and Research Hospital1 site in 1 country160 target enrollmentStarted: January 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
160
Locations
1
Primary Endpoint
TAMPA Kinesiophobia Scale

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts 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

Outcomes

Primary Outcomes

TAMPA Kinesiophobia Scale

Time Frame: 1 year

The 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 Test

Time Frame: 1 year

This 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 Outcomes

  • Visual Analogue scale(1 year)
  • Fibromyalgia Impact Questionnaire(1 year)
  • Hospital Anxiety/ Depression Questionnaire(1 year)
  • Short Form-36(1 year)
  • International Physical Activity Questionnaire-Short Form(1 year)

Investigators

Sponsor
Bozyaka Training and Research Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Şeniz Akçay

Study Director

Bozyaka Training and Research Hospital

Study Sites (1)

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