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FibromyalgiaNCT07358702

Sedentary Status and Multidimensional Outcomes in Fibromyalgia

A study testing Assessment Only in people with Fibromyalgia and Sedentary Behavior, run by Izmir Democracy University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Fibromyalgia, Sedentary Behavior, Kinesiophobia
What is being tested?
Assessment Only
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 May 2026to 15 Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 Inclusion Criteria - Non-Sedentary Fibromyalgia Participants
  • Physical activity level above 600 MET-min/week according to the IPAQ
  • Diagnosis of fibromyalgia according to the 2016 ACR criteria
Show all 13Show fewer
  • Age between 18 and 65 years
  • Ability to understand and respond to study assessments
  • Exclusion Criteria - Non-Sedentary Fibromyalgia Participants
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ferruh Taşpınar, Prof.Dr. contact

+905426853877

ferruh.taspinar@idu.edu.tr

Betül Taşpınar, Prof.Dr. contact

+905066804426

betul.taspinar@idu.edu.tr

Turkey (Türkiye)1 site
  • Betül TAŞPINAR

    Konak, İ̇zmi̇r

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Body Awareness, Respiratory Muscle Strength, Kinesiophobia, Central Sensitization, Functional Status and Sleep Quality in Sedentary and Non-Sedentary Fibromyalgia Individuals

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.

Read the detailed description

Fibromyalgia syndrome (FMS) is a chronic pain condition characterized by widespread musculoskeletal pain, sleep disturbances, and fatigue. Along with other symptoms such as joint stiffness, depression, anxiety, and cognitive dysfunction, FMS restricts daily life, negatively affects physical activity, and reduces individuals' ability to cope with daily demands. Moreover, FMS can lead to reduced productivity, work-related disability, and increased healthcare costs. As a result, patients experience limitations in activities of daily living and overall functional capacity. As a chronic pain condition, FMS may contribute to impaired functional capacity through the adoption of sedentary behaviors. Pain and fatigue associated with FMS often lead to physical inactivity, resulting in muscle deconditioning and, consequently, increased pain and fatigue, creating a vicious cycle. FMS affects approximately 2-6% of the global population and is the second most common rheumatologic disorder after osteoarthritis. However, the pathogenesis of the disease has not yet been fully elucidated.

Body awareness refers to the ability to perceive bodily sensations, movements, and the relationship between the body and its environment. In individuals with FMS, body awareness is often impaired, leading to difficulties in recognizing and interpreting bodily signals related to pain, fatigue, and stress. This impairment in body awareness may exacerbate symptoms and hinder the implementation of effective coping strategies. Enhanced body awareness allows patients to identify factors that trigger pain and to develop more effective coping mechanisms. Previous studies have demonstrated that therapeutic approaches focusing on body awareness are beneficial in reducing pain levels and improving movement quality in individuals with FMS.

Body awareness is also associated with psychological factors commonly observed in individuals with FMS, such as anxiety and depression. It has been reported that as body awareness increases, individuals with FMS are better able to analyze their emotional responses to their physical condition, which may help reduce anxiety levels. Furthermore, studies have shown that interventions aimed at improving body awareness result in positive changes in psychological functioning, including reductions in anxiety and depression, in individuals with FMS.

Compared with healthy individuals, people with FMS exhibit lower respiratory muscle strength and endurance. Studies in the literature indicate that maximal inspiratory pressure and maximal expiratory pressure-important indicators of respiratory muscle performance-are reduced in individuals with FMS. This reduction can cause difficulty in breathing during physical activities, contributing to a persistent cycle of fatigue and weakness. A correlation has been observed between respiratory muscle strength and the severity of FMS symptoms. Previous studies have demonstrated that reduced inspiratory muscle strength is associated with a higher number of tender points, greater fatigue severity, and decreased thoracic mobility.

Participation in physical activities among individuals with FMS is often limited due to pain and fatigue, and the resulting increase in physical inactivity further reduces respiratory muscle strength. Interventions aimed at improving respiratory muscle strength have been shown to enhance exercise tolerance, physical function, and quality of life, while also reducing pain and fatigue.

Kinesiophobia, defined as an excessive and debilitating fear of movement or physical activity, plays a significant role in disease management and the development of coping strategies in individuals with FMS. Kinesiophobia is observed in more than 38% of individuals with FMS. High levels of kinesiophobia have been associated with increased pain intensity, disease activity, and depression severity, as well as decreased physical activity and quality of life. Individuals with FMS often perceive pain as a threat, leading to increased avoidance of physical activity. As a result, fear-avoidance behaviors develop, which exacerbate FMS symptoms and increase levels of disability.

Central sensitization refers to increased responsiveness of the central nervous system (CNS) to stimulation. This phenomenon occurs when the CNS becomes excessively sensitive to sensory input, resulting in heightened pain perception in response to normally non-painful stimuli (allodynia) or exaggerated responses to painful stimuli (hyperalgesia). Although central sensitization is not specific to FMS, it plays a crucial role in its pathophysiology. Central sensitization involves complex neurobiological processes, including alterations in neurotransmitter levels, neuronal pathways, and brain structure and function. These changes are influenced by genetic predisposition, previous injuries, stress, and psychological factors.

Fibromyalgia is generally considered a central sensitization syndrome. Chronic pain in individuals with FMS is believed to arise primarily from central sensitization rather than peripheral tissue injury or inflammation. Proinflammatory cytokines are frequently elevated in patients with fibromyalgia and contribute to the development of central sensitization. These cytokines may activate glial cells in the CNS, leading to persistent pain perception.

Sleep disturbances are a common symptom in individuals with FMS. Patients frequently report difficulty falling asleep, frequent nighttime awakenings, and waking up feeling unrefreshed. These disturbances are often attributed to alterations in normal brain wave activity, which prevent the transition into deep sleep stages necessary for physical restoration and mental clarity. Individuals with FMS may also report a subjective sensation of swelling in muscles and joints, although this finding is not typically observed during physical examination.

Approximately 90% of individuals with FMS experience sleep disorders, including insomnia, restless legs syndrome, and sleep apnea. A bidirectional relationship exists between sleep and pain in FMS. Poor sleep quality increases pain sensitivity and lowers pain thresholds, while increased pain severity exacerbates sleep disturbances, creating a vicious cycle. In addition to its effects on pain severity, poor sleep quality has been shown to negatively impact cognitive function, fatigue, anxiety, and depression.

Physical activity is defined as any bodily movement produced by skeletal muscles that results in energy expenditure and includes both activities of daily living and planned exercise. Studies have shown that individuals with FMS have lower levels of physical activity compared with healthy individuals. Only 37% of individuals with FMS meet the guideline-recommended level of at least 150 minutes of moderate-to-vigorous physical activity per week. Additionally, individuals with FMS take an average of 5,663.7 steps per day, which is below the recommended daily target of 6,000 steps. Compared with healthy individuals, they also spend less time engaging in daily activities such as leisure and transportation. Approximately 36.6% of individuals with fibromyalgia are classified as inactive, while an additional 45.1% are considered insufficiently active.

The primary barriers to physical activity in individuals with FMS include persistent fatigue, pain, fear of symptom exacerbation with exertion, disability, mood disorders, low self-efficacy for movement, and inadequate social support. Chronic pain and fatigue lead individuals with FMS to avoid physical activity. Many individuals believe that physical activity will worsen their symptoms, resulting in fear-avoidance behaviors. The combination of inactivity and pain often leads to reduced muscle strength, making activities of daily living more difficult. Studies have demonstrated that individuals with FMS exhibit decreased physical conditioning, low cardiorespiratory endurance, and reduced muscle strength and endurance. Despite these barriers, regular physical activity provides numerous benefits for individuals with FMS.

Physical activity has been reported to alleviate FMS symptoms by increasing the release of neurotransmitters such as endorphins and serotonin. Additionally, physical activity plays an important role in influencing fatigue both directly and indirectly through regulation of the hypothalamic-pituitary-adrenal axis and autonomic nervous system function. When physical activity is performed in group settings, social interaction may enhance well-being and reduce psychological distress, thereby improving quality of life. It has been demonstrated that engaging in light- to moderate-intensity physical activity and exercise two to three times per week increases muscle strength, reduces pain, improves flexibility, and enhances quality of life in individuals with FMS.

Although studies have compared physical activity levels between individuals with FMS and healthy controls, there is currently no study comparing body awareness, respiratory muscle strength, kinesiophobia, central sensitization, functional status, and sleep quality between sedentary and non-sedentary individuals with fibromyalgia.

Being tested
Assessment Only
Keywords
Fibromyalgia Syndrome, Sedentary Behavior, Functional Status
Medical subject headings
Fibromyalgia, Sedentary Behavior, Kinesiophobia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Assessment OnlyOther

    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.

Study groups in NCT07358702
Study groupRoleWhat they receive
Sedentary Fibromyalgia GroupOtherIndividuals diagnosed with fibromyalgia syndrome who meet the criteria for sedentary behavior.
Receives: Other: Assessment Only
Non-Sedentary Fibromyalgia GroupOtherIndividuals diagnosed with fibromyalgia syndrome who do not meet the criteria for sedentary behavior.
Receives: Other: Assessment Only

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline

  2. 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).

    Measured: Baseline

  3. 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.

    Measured: Baseline

  4. 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.

    Measured: Baseline

  5. 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.

    Measured: Baseline

  6. 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.

    Measured: Baseline

  7. 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

    Measured: Baseline

  8. 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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2026
  2. Study start15 May 2026 (estimated)
  3. Primary completion15 Oct 2026 (estimated)
  4. Study completion15 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Crossover
Model description
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.
Masking
None (open label)
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07358702
Sponsor's protocol ID
Sedentary FMS-35
Status last verified
Feb 2026
First submitted
13 Jan 2026
Last updated
6 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Assessment Only in people with Fibromyalgia and Sedentary Behavior, run by Izmir Democracy University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ferruh Taşpınar, Prof.Dr. (+905426853877, ferruh.taspinar@idu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

International Physical Activity Questionnaire (IPAQ) - Short Form (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.

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