Sedentary Status and Multidimensional Outcomes in Fibromyalgia

NCT07358702 | Not Yet Recruiting

• 1 other identifier: Sedentary FMS-35
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Fibromyalgia syndrome (FMS) is a chronic condition characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, and functional limitations. Pain, fatigue, and fear of movement often lead individuals with FMS to adopt sedentary behaviors, which may further exacerbate symptoms and reduce physical capacity. Factors such as impaired body awareness, reduced respiratory muscle strength, kinesiophobia, central sensitization, poor functional status, and sleep disturbances play an important role in disease severity and quality of life in individuals with FMS. Although physical inactivity is common in fibromyalgia, limited evidence exists regarding the differences in these multidimensional clinical parameters between sedentary and non-sedentary individuals with FMS. Therefore, the aim of this study is to compare body awareness, respiratory muscle strength, kinesiophobia, central sensitization, functional status, and sleep quality between sedentary and non-sedentary individuals diagnosed with fibromyalgia syndrome. The findings of this study may contribute to a better understanding of the impact of sedentary behavior on clinical outcomes in fibromyalgia and help guide more comprehensive and individualized rehabilitation approaches.

Conditions

Fibromyalgia; Sedentary Behavior; Kinesiophobia; Central Sensitisation

Keywords

Fibromyalgia Syndrome; Sedentary Behavior; Functional Status

Outcome Measures

Primary Outcomes (8)

• International Physical Activity Questionnaire (IPAQ) - Short Form

  The International Physical Activity Questionnaire (IPAQ) is commonly used to assess physical activity. In this study, the 7-item short form of the IPAQ will be used. The questionnaire evaluates the number of days and duration over the past 7 days in which participants performed vigorous physical activity, moderate physical activity, and walking for at least 10 minutes per session. Total physical activity is calculated by multiplying the duration and frequency of each activity by its MET value: 8 MET for vigorous, 4 MET for moderate, and 3.3 MET for walking. Sedentary time is not included in the calculation. The weekly MET score is summed across all activities: \<600 MET-min/week is considered inactive, 601-3,000 MET-min/week moderately active, and \>3,000 MET-min/week active

  Baseline

• Mindful Attention Awareness Scale (MAAS)

  The MAAS is a 15-item scale measuring the general tendency to be aware of and attentive to present-moment experiences. The scale is unidimensional, yielding a single total score, where higher scores indicate greater mindfulness. Items are rated on a 6-point Likert scale from 1 (almost always) to 6 (almost never).

  Baseline

• Postural Awareness Scale (PAS)

  The Postural Awareness Scale evaluates individuals' postural awareness and efforts to regulate their posture. It consists of two factors and a total of 11 items. Total scores range from 11 to 77, with higher scores indicating better postural awareness.

  Baseline

• Fibromyalgia Impact Questionnaire (FIQ)

  The Fibromyalgia Impact Questionnaire (FIQ) assesses functional status in fibromyalgia patients. The FIQ evaluates 10 domains: physical function, feeling well, work difficulty, work missed, pain, fatigue, morning tiredness, stiffness, anxiety, and depression. Excluding the "feeling well" domain, lower scores indicate better function. The questionnaire is patient-reported and takes approximately 5 minutes to complete, with a total score of 100. Physical Function Subscale: 11 questions scored 0-3, summed and averaged, then multiplied by 3.33 (range 0-33).Feeling Well Subscale: Reverse-scored, average multiplied by 1.43 (range 0-7).Work Missed Subscale: Directly scored, multiplied by 1.43. Other domains: Scored 0-10 per item; higher scores indicate greater impairment. All scores are summed to obtain a total FIQ score.

  Baseline

• Tampa Scale of Kinesiophobia (TSK)

  The Tampa Scale for Kinesiophobia (TSK) was originally developed to assess fear of movement. The scale has 17 items, rated on a 4-point Likert scale (1 = strongly disagree to 4 = strongly agree). Items 4, 8, 12, and 16 are reverse-scored. Higher total scores indicate higher kinesiophobia.

  Baseline

• Central Sensitization Inventory (CSI)

  The CSI assesses symptoms related to central sensitization in individuals with chronic pain. It consists of two parts: Part A evaluates 25 somatic and psychosocial symptoms commonly associated with central sensitization; Part B identifies medical conditions known to be related to central sensitization (not scored). Total scores are out of 100, with ≥40 indicating the presence of central sensitization.

  Baseline

• Pittsburgh Sleep Quality Index (PSQI)

  The PSQI is a 24-item self-report questionnaire evaluating sleep quality and disturbances. The first 19 items are self-rated, and the remaining 5 are answered by a partner or roommate but are not included in scoring. Higher total scores indicate worse sleep quality. Seven subcomponents are scored 0-3: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Total scores range from 0-21; scores ≥5 indicate poor sleep quality

  Baseline

• Respiratory Muscle Strength Assessment

  Respiratory muscle strength will be measured using the Cosmed Pony FX spirometer. Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) will be assessed. MIP: Participant performs maximal expiration in a seated position, followed by maximal inspiration against a closed airway for 1-3 seconds. MEP: Participant performs maximal inspiration, followed by maximal expiration against a closed airway for 1-3 seconds. Three measurements will be taken, and the best value will be recorded. Age- and sex-specific reference values will be used.

  Baseline

Study Arms (2)

Sedentary Fibromyalgia Group

OTHER

Individuals diagnosed with fibromyalgia syndrome who meet the criteria for sedentary behavior.

Other: Assessment Only

Non-Sedentary Fibromyalgia Group

OTHER

Individuals diagnosed with fibromyalgia syndrome who do not meet the criteria for sedentary behavior.

Other: Assessment Only

Interventions

Assessment Only OTHER

No therapeutic intervention will be applied in this study. Participants will undergo a comprehensive assessment to evaluate clinical and functional characteristics. Assessments will include body awareness, respiratory muscle strength, kinesiophobia, central sensitization, functional status, sleep quality, and physical activity level. All evaluations will be conducted at a single time point using validated clinical measurement tools and self-reported questionnaires. The purpose of these assessments is to compare sedentary and non-sedentary individuals with fibromyalgia syndrome in terms of multidimensional clinical outcomes.

Non-Sedentary Fibromyalgia Group; Sedentary Fibromyalgia Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physical activity level below 600 MET-min/week according to the International Physical Activity Questionnaire (IPAQ)
• Diagnosis of fibromyalgia according to the 2016 ACR criteria
• Age between 18 and 65 years
• Ability to understand and respond to study assessments

You may not qualify if:

• Conditions posing risk during assessments, including unstable angina, decompensated heart failure, or myocardial infarction within the past month
• Uncontrolled diabetes, hypertension \>180/110 mmHg, and/or severe neuropathy
• Diagnosed severe cognitive impairment
• Physical activity level above 600 MET-min/week according to the IPAQ
• Diagnosis of fibromyalgia according to the 2016 ACR criteria
• Age between 18 and 65 years
• Ability to understand and respond to study assessments
• Conditions posing risk during assessments, including unstable angina, decompensated heart failure, or myocardial infarction within the past month
• Uncontrolled diabetes, hypertension \>180/110 mmHg, and/or severe neuropathy
• Diagnosed severe cognitive impairment
• Pregnancy or suspected pregnancy

Sponsors & Collaborators

• Izmir Democracy University: lead

Study Sites (1)

Betül TAŞPINAR

Konak, İ̇zmi̇r, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia; Sedentary Behavior; Kinesiophobia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Behavior; Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Onur Engin, Asst.Prof.

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

• Ayşe Sezgi Kızılırmak Karataş, Asst.Prof

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

• Büşra Aydın, std.

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

• Öykü Dündar, std.

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

• Turna Sümen, std.

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

• Nalan Anık, std.

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

• Kader İliman, std.

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

• Fadıma Kılıç, std.

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ferruh Taşpınar, Prof.Dr.

CONTACT

+905426853877; ferruh.taspinar@idu.edu.tr

Betül Taşpınar, Prof.Dr.

CONTACT

+905066804426; betul.taspinar@idu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr.

Model Details: Individuals diagnosed with fibromyalgia syndrome will be categorized into two groups based on their physical activity level: sedentary and non-sedentary. The groups will be compared in terms of body awareness, respiratory muscle strength, kinesiophobia, central sensitization, functional status, and sleep quality. The aim is to evaluate the differences in these multidimensional clinical parameters between sedentary and non-sedentary individuals with fibromyalgia.

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 22, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): January 15, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

TU (1)