Fibromyalgia Syndrome
Conditions
Keywords
Basic Body Awareness; Fibromyalgia; Exercise; Cortisol; Interleukin-6
Brief summary
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.
Interventions
BEHAVIORALBasic Body Awareness Therapy
Basic 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.
BEHAVIORALModerate-Intensity Aerobic Exercise
Moderate-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.
Sponsors
Hacer Önen Tekin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This study is conducted as an open-label trial. Due to the nature of the interventions (aerobic exercise and Basic Body Awareness Therapy), blinding of participants, care providers, and investigators is not feasible. All participants and researchers are aware of group allocation throughout the study period.
Intervention model description
Participants will be randomly assigned to one of two parallel groups. The intervention group will receive moderate-intensity aerobic exercise combined with Basic Body Awareness Therapy, while the control group will receive moderate-intensity aerobic exercise only. Outcomes will be assessed at baseline and after the intervention period.
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 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) * Willingness to participate voluntarily in the exercise program twice per week for 12 weeks * Ability to understand study procedures and provide written informed consent
Exclusion criteria
* Presence of any central or peripheral nervous system disease * Presence of progressive neurological disorders * Uncontrolled hypertension * Presence of cardiovascular disease or pathology * Use of psychotropic medications within the past 1 month * Presence of any musculoskeletal disorder other than fibromyalgia * Pregnancy * Presence of cognitive impairment that may affect cooperation or compliance with study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Interleukin-6 (IL-6) | Baseline (before the first exercise session), after the first exercise session (Day 1), and at the end of 12 weeks. | 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 | Baseline (before the first exercise session), after the first exercise session (Day 1), and at the end of 12 weeks. | 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
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Function Assessed by Trail Making Test | Baseline (before the first exercise session), after the first exercise session (Day 1), and at the end of 12 weeks. | 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 | Baseline (before the first exercise session), after the first exercise session (Day 1), and at the end of 12 weeks. | 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) | Baseline (before the first exercise session), after the first exercise session (Day 1), and at the end of 12 weeks. | Pain intensity will be evaluated using a 10-cm Visual Analog Scale (VAS). |
| Pressure Pain Threshold Measured by Pressure Algometer | Baseline (before the first exercise session), after the first exercise session (Day 1), and at the end of 12 weeks. | Pressure pain threshold will be measured using a pressure algometer at standardized tender point sites. |
| Fibromyalgia Disease Severity Assessed by Revised Fibromyalgia Impact Questionnaire (FIQR) | Baseline (before the first exercise session), after the first exercise session (Day 1), and at the end of 12 weeks. | Disease severity will be evaluated using the Revised Fibromyalgia Impact Questionnaire (FIQR). |
| Health-Related Quality of Life Measured by SF-36 | Baseline (before the first exercise session), after the first exercise session (Day 1), and at the end of 12 weeks. | Health-related quality of life will be assessed using the Short Form-36 Health Survey (SF-36). |
| Cognitive Function Assessed by Stroop Test | Baseline (before the first exercise session) and at the end of 12 weeks. | Cognitive function including attention, processing speed, executive function, and cognitive flexibility will be evaluated using the Stroop Test. |
Contacts
CONTACTHacer ÖNEN TEKİN, MSc
Outcome results
None listed