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

NCT07851896 | Not Yet Recruiting

• 2 other identifiers: FMS-BBAT-AE-2025Istinye-FTR-FMS-2025-01
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fibromyalgia Syndrome

Keywords

Basic Body Awareness; Fibromyalgia; Exercise; Cortisol; Interleukin-6

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (7)

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

Aerobic Exercise + Basic Body Awareness Therapy

EXPERIMENTAL

Participants in this group will receive a supervised moderate-intensity aerobic exercise program combined with Basic Body Awareness Therapy. The aerobic exercise program will be administered according to standardized protocols, and Basic Body Awareness Therapy will be applied as an adjunct intervention focusing on posture, movement quality, breathing, and body awareness. The intervention will be conducted over the predefined study period under the supervision of a physiotherapist.

Behavioral: Basic Body Awareness Therapy

Aerobic Exercise Only

EXPERIMENTAL

Participants in this group will receive a supervised moderate-intensity aerobic exercise program according to standardized protocols. No additional therapeutic interventions will be applied. The intervention will be conducted over the predefined study period under the supervision of a physiotherapist.

Behavioral: Moderate-Intensity Aerobic Exercise

Interventions

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.

Also known as: BBAT

Aerobic Exercise + 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.

Also known as: Aerobic exercise training

Aerobic Exercise Only

Eligibility Criteria

• Age: 30 Years - 50 Years
• Gender Eligibility Details: This study is restricted to female participants, as fibromyalgia predominantly affects women and gender-related biological and psychosocial differences may influence inflammatory markers, cortisol response, and treatment outcomes.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacer Önen Tekin: lead

MeSH Terms

Conditions

Fibromyalgia; Motor Activity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Behavior

Central Study Contacts

Hacer ÖNEN TEKİN, MSc

CONTACT

+905414202156; 229912820@stu.istinye.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: October 1, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): November 15, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share