Effects of Basic Body Awareness Therapy Added to Aerobic Exercise in Women With Fibromyalgia

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30-50
SponsorHacer Önen Tekin

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Basic Body Awareness Therapy

    Behavioral

    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.

  • Moderate-Intensity Aerobic Exercise

    Behavioral

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Aerobic Exercise + Basic Body Awareness TherapyExperimental treatment 1 intervention
Group B: Aerobic Exercise OnlyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (before the first exercise session), after the first exercise session (Day 1), and at the end of 12 weeks.
2

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.

Time frame
Baseline (before the first exercise session), after the first exercise session (Day 1), and at the end of 12 weeks.

Secondary outcomes

1

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).

Time frame
Baseline (before the first exercise session), after the first exercise session (Day 1), and at the end of 12 weeks.
2

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).

Time frame
Baseline (before the first exercise session), after the first exercise session (Day 1), and at the end of 12 weeks.
3

Pain Intensity Measured by Visual Analog Scale (VAS)

Pain intensity will be evaluated using a 10-cm Visual Analog Scale (VAS).

Time frame
Baseline (before the first exercise session), after the first exercise session (Day 1), and at the end of 12 weeks.
4

Pressure Pain Threshold Measured by Pressure Algometer

Pressure pain threshold will be measured using a pressure algometer at standardized tender point sites.

Time frame
Baseline (before the first exercise session), after the first exercise session (Day 1), and at the end of 12 weeks.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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Hacer Önen Tekin

Lead sponsor

Istinye University

Sponsor institution

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