Sedentary Status and Multidimensional Outcomes in Fibromyalgia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIzmir Democracy University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Sedentary Fibromyalgia Participants
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Assessment Only
Other interventionNo 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.
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: Sedentary Fibromyalgia GroupOther 1 intervention
Group B: Non-Sedentary Fibromyalgia GroupOther 1 intervention
Trial outcomes
Primary outcomes
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
Time frame
Baseline2
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).
Time frame
Baseline3
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.
Time frame
Baseline4
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.
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov
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