Fibromyalgia SyndromeBBAT-FMSNCT07851896
Effects of Basic Body Awareness Therapy Added to Aerobic Exercise in Women With Fibromyalgia
A study testing Basic Body Awareness Therapy and Moderate-Intensity Aerobic Exercise in people with Fibromyalgia Syndrome, run by Hacer Önen Tekin.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- Fibromyalgia Syndrome
- What is being tested?
- Basic Body Awareness Therapy and Moderate-Intensity Aerobic Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2026to 15 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Basic Body Awareness Therapy Added to Moderate-Intensity Aerobic Exercise on IL-6, Cortisol Levels, Cognitive Function, and Depression in Women With Fibromyalgia: A Randomized Controlled 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.
- Conditions
- Fibromyalgia Syndrome
- Being tested
- Basic Body Awareness Therapy, Moderate-Intensity Aerobic Exercise
- Keywords
- Basic Body Awareness; Fibromyalgia; Exercise; Cortisol; Interleukin-6
- Medical subject headings
- Fibromyalgia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic Body Awareness TherapyBehavioural
Also called BBAT
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 ExerciseBehavioural
Also called Aerobic exercise training
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Moderate-Intensity Aerobic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Cognitive function including attention, processing speed, executive function, and cognitive flexibility will be evaluated using the Trail Making Test (Parts A and B).
Measured: 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
Depression levels will be assessed using the Depression subscale of the Depression Anxiety Stress Scale-21 (DASS-21).
Measured: 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)
Pain intensity will be evaluated using a 10-cm Visual Analog Scale (VAS).
Measured: 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
Pressure pain threshold will be measured using a pressure algometer at standardized tender point sites.
Measured: 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)
Disease severity will be evaluated using the Revised Fibromyalgia Impact Questionnaire (FIQR).
Measured: 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 Measured by SF-36
Health-related quality of life will be assessed using the Short Form-36 Health Survey (SF-36).
Measured: Baseline (before the first exercise session), after the first exercise session (Day 1), and at the end of 12 weeks.
Cognitive Function Assessed by Stroop Test
Cognitive function including attention, processing speed, executive function, and cognitive flexibility will be evaluated using the Stroop Test.
Measured: Baseline (before the first exercise session) and at the end of 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacer Önen Tekin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hacer Önen Tekin, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07851896
- Sponsor's protocol ID
- FMS-BBAT-AE-2025
- Other IDs
- Istinye-FTR-FMS-2025-01
- Acronym
- BBAT-FMS
- Status last verified
- Sep 2026
- First submitted
- 22 Dec 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. The study is a single-center, thesis-based academic research project, and data sharing is not planned beyond aggregate results reported in scientific publications, in accordance with ethics committee approval and participant consent.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Basic Body Awareness Therapy Added to Moderate-Intensity Aerobic Exercise on IL-6, Cortisol Levels, Cognitive Function, and Depression in Women With Fibromyalgia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07851896
- Acronym / sponsor ID
- BBAT-FMS / FMS-BBAT-AE-2025
- Conditions
- Fibromyalgia Syndrome
- Keywords
- Basic Body Awareness; Fibromyalgia; Exercise; Cortisol; Interleukin-6
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hacer Önen TekinUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Nov 2027 (estimated)
- First posted
- 1 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise + Basic Body Awareness Therapy | Experimental | Behavioral: Basic Body Awareness TherapyParticipants 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. |
| Aerobic Exercise Only | Experimental | Behavioral: Moderate-Intensity Aerobic ExerciseParticipants 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. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Basic Body Awareness TherapyAlso: BBATBasic 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. | Behavioural | Aerobic Exercise + Basic Body Awareness Therapy |
| Moderate-Intensity Aerobic ExerciseAlso: Aerobic exercise trainingModerate-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. | Behavioural | Aerobic Exercise Only |
Primary outcome
Interleukin-6 (IL-6)
Time frame: 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
Time frame: 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.
7 secondary outcomes
Cognitive Function Assessed by Trail Making Test
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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 Measured by SF-36
Time frame: Baseline (before the first exercise session), after the first exercise session (Day 1), and at the end of 12 weeks.
Cognitive Function Assessed by Stroop Test
Time frame: Baseline (before the first exercise session) and at the end of 12 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. The study is a single-center, thesis-based academic research project, and data sharing is not planned beyond aggregate results reported in scientific publications, in accordance with ethics committee approval and participant consent.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Basic Body Awareness Therapy and Moderate-Intensity Aerobic Exercise in people with Fibromyalgia Syndrome, run by Hacer Önen Tekin.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hacer ÖNEN TEKİN, MSc (+905414202156, 229912820@stu.istinye.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interleukin-6 (IL-6) (time frame: Baseline (before the first exercise session), after the first exercise session (Day 1), and at the end of 12 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.