About this trial
This study aims to investigate the effects of Basic Body Awareness Therapy combined with aerobic exercise on inflammatory biomarkers (interleukin-6 and cortisol), cognitive functions, and depression levels in women diagnosed with fibromyalgia syndrome. Participants will be randomly assigned to an intervention group receiving aerobic exercise plus Basic Body Awareness Therapy or a control group receiving aerobic exercise alone. Clinical, biochemical, cognitive, and psychological assessments will be conducted at baseline and after the intervention period. The findings are expected to contribute to evidence-based non-pharmacological rehabilitation approaches for fibromyalgia management.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female participants aged 30 to 50 years
Diagnosed with fibromyalgia according to established diagnostic criteria
Presence of fibromyalgia-related symptoms for at least 3 months
Physically inactive according to the International Physical Activity Questionnaire (IPAQ) - Short Form (weekly physical activity level < 600 MET-min/week)
Disqualifiers
Presence of any central or peripheral nervous system disease
Presence of progressive neurological disorders
Uncontrolled hypertension
Presence of cardiovascular disease or pathology
Trial design
Parallel
Treatments tested in this trial
Basic Body Awareness Therapy
BehavioralBasic Body Awareness Therapy is a physiotherapy-based intervention focusing on movement awareness, posture, balance, breathing, and body perception. The therapy aims to improve movement quality and bodily awareness through guided exercises performed in standing, sitting, and lying positions. Sessions are conducted by a trained physiotherapist according to standardized principles of Basic Body Awareness Therapy.
Moderate-Intensity Aerobic Exercise
BehavioralModerate-intensity aerobic exercise consists of structured physical activity designed to improve cardiovascular endurance. Exercise intensity is prescribed and monitored according to standardized guidelines. The program is supervised by a physiotherapist and performed regularly throughout the intervention period.
Treatment groups
Trial outcomes
Primary outcomes
Interleukin-6 (IL-6)
Changes in serum interleukin-6 (IL-6) concentration will be assessed using standardized laboratory assay methods to evaluate the biological effects of aerobic exercise with or without Basic Body Awareness Therapy in women with fibromyalgia.
Cortisol
Changes in cortisol concentration will be assessed using standardized laboratory assay methods to evaluate the biological effects of aerobic exercise with or without Basic Body Awareness Therapy in women with fibromyalgia.
Secondary outcomes
Cognitive Function Assessed by Trail Making Test
Cognitive function including attention, processing speed, executive function, and cognitive flexibility will be evaluated using the Trail Making Test (Parts A and B).
Depression Level Measured by Depression Anxiety Stress Scale-21 (DASS-21) Depression Subscale
Depression levels will be assessed using the Depression subscale of the Depression Anxiety Stress Scale-21 (DASS-21).
Pain Intensity Measured by Visual Analog Scale (VAS)
Pain intensity will be evaluated using a 10-cm Visual Analog Scale (VAS).
Pressure Pain Threshold Measured by Pressure Algometer
Pressure pain threshold will be measured using a pressure algometer at standardized tender point sites.
Locations
Sponsors and contacts
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Hacer Önen Tekin
Lead sponsor
Istinye University
Sponsor institution
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