FibromyalgiaNCT07034417
The Effectiveness Of BETY In Fibromyalgia
A study testing Exercise and Home exercise in people with Fibromyalgia, run by Aysima Barlak at 1 site in Turkey (Türkiye).
Trial summary
Fibromyalgia Syndrome (FMS) is a nonarticular, chronic rheumatic disorder of unknown etiology characterized by widespread musculoskeletal pain, impaired sleep quality, fatigue and the presence of identified tender points. Pain, the main symptom of the disease, is described as chronic and widespread. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Exercise and Home exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Jul 2025to 12 Feb 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being diagnosed with fibromyalgia
- 18 years of age or older
- Being literate
- Having read and signed the informed consent
- Not exercising regularly in the last 3 months
Who cannot join
- Having a malignant disease
- Pregnancy
- Having chronic infectious or other rheumatologic diseases
- Having undergone a surgical operation in the last 6 months
- Collagen tissue disease
- History of peripheral vascular disease or neuropathy
- Presence of diseases that cannot be controlled and prevent exercise
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Alanya Alaaddin Keykubat University
Antalya, Alanya, 07425
Kübra Sargın Baskın, PT, MSc, 5335664516, kubrasbaskin@hotmail.com
Edibe Ünal, PT, PhD, Prof
About this study
Official title: Investigation The Effectiveness Of Cognitive Exercise Therapy Approach (Bilişsel Egzersiz Terapi Yaklaşımı - BETY) In Individuals With Fibromyalgia
Fibromyalgia Syndrome (FMS) is a nonarticular, chronic rheumatic disorder of unknown etiology characterized by widespread musculoskeletal pain, impaired sleep quality, fatigue and the presence of identified tender points. Pain, the main symptom of the disease, is described as chronic and widespread. It is reported that the pain usually starts in the neck and shoulders but becomes widespread by being felt in various parts of the body during the day. Although it is difficult to localize the pain, it is reported to be localized to the paracervical and trapezius muscle and paralumbar and gluteal body parts.
Cognitive Exercise Therapy Approach is an innovative exercise approach developed on the basis of biopsychosocial model on individuals with rheumatism. This method has a unique scale that offers biopsychosocial assessment. There is the Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire (BETY-BQ). Validity, reliability and sensitivity studies of BETY-BQ have been conducted in individuals with fibromyalgia. This study aims to examine the effect of BETY, an exercise approach developed on the basis of the biopsychosocial model, on individuals with fibromyalgia.
- Conditions
- Fibromyalgia
- Being tested
- Exercise, Home exercise
- Keywords
- biopsychosocial model, pain, functional capacity, depression, anxiety, quality of life
- Medical subject headings
- Fibromyalgia, Pain, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Cognitive Exercise Therapy Approach
Home exerciseOther
Home exercise
| Study group | Role | What they receive |
|---|---|---|
| BETY Group | Experimental | BETY exercise sessions Receives: Other: Exercise |
| Control Group | Other | Home exercise program Receives: Other: Home exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Exercise Therapy Approach (BETY)- Biopsychosocial Questionnaire
The BETY Questionnaire was developed on rheumatic patients and was introduced to the literature as a standardized biopsychosocial measurement tool as a result of improving the definitions of recovery from patients with expert opinions and statistical analysis. Scoring of the scale is done using a 5-point Likert system, each item is scored between 0 and 4 points, and a high total score in the scale consisting of a total of 30 items indicates a high biopsychosocial impact.
Measured: 3 mounths
Secondary outcomes (12)
Hospital Anxiety Depression Scale (HADS)
Although the HADS was developed 20 years ago for the clinical measurement of anxiety and depression levels and was originally developed for hospitalized individuals, it now has a wide spectrum of use and can be used in many situations, including healthy people. Seven of the 14 items provide insight into the level of anxiety, while seven include questions about the level of depression. Each question is scored between 0 and 3, with a high score indicating high affectivity. Anxiety and depression sub-parameters are scored separately and 11 points and above are considered abnormal.
Measured: 3 mounths
Health Asessement Questionnaire (HAQ)
It is a scale developed in individuals with rheumatoid arthritis and can be used in a wide range of populations while assessing all rheumatic disease groups. It has 8 subheadings and consists of a total of 20 questions. Sub-headings include dressing, sitting and staying, eating, walking, hygiene, reaching, grasping and activities of daily living. Each answer is scored between 0 and 3 points and the higher the score, the more difficult the activity is.
Measured: 3 mounths
Short Form - 36
SF-36 scale will be used to determine the level of health status and quality of life of individuals.SF-36 is a patient-oriented assessment scale created in the United States of America that allows for general health screening.Each sub-parameter is scored between 0 and 100 points and a high score indicates good health status.The SF-36 scale has 8 sub-parameters including general health perception, physical function, social function, pain, mental health, role difficulties due to physical causes, role difficulties due to emotional causes and vitality and includes 11 questions with a total of 36 items.
Measured: 3 mounths
Pain Catastrophizing Scale
This scale, developed by Sullivan et al. (1995), measures the exaggerated negative mental reaction of individuals to current or anticipated painful experiences and the extent to which they catastrophize pain.The reliability and validity of the Turkish version of the scale was demonstrated by Uğurlu et al. (2017) and consists of 13 items.Each item is scored as never=0, slightly=1, moderately=2, greatly=3 and always=4.A high total score indicates a high degree of catastrophizing of pain.
Measured: 3 mounths
Fatigue Severity Scale
It is a scale that evaluates fatigue and consists of 9 questions. Each item is scored between 0 and 7. The total score is divided by 9 and a mean score of <4 indicates no fatigue and a mean score of ≥4 indicates fatigue.
Measured: 3 mounths
Tampa Scale of Kinesiophobia
This scale is a 17-question scale developed to measure fear of movement/reinjury.The scale includes parameters of injury/re-injury and fear-avoidance in work-related activities
Measured: 3 mounths
Fibromyalgia Impact Questionnaire
It is used to evaluate the health status and physical functionality of the individual diagnosed with fibromyalgia. It is a 10-question scale that assesses physical function, work status, productivity level, depression, anxiety, sleep, pain, stiffness, fatigue and well-being.
Measured: 3 mounths
Brief Illness Perception Questionnaire
The other 7 items in the scale have a Likert-type scoring scale from 0 to 10. The scale consists of two sub-dimensions (cognitive and emotional). The eighth item consists of an open-ended question. Individuals are asked to answer open-ended questions about the three most important reasons for the illness. A high score indicates that the illness is threatening and a low score indicates that the person is comfortable.
Measured: 3 mounths
McGill Pain Questionnaire Short Form
Developed by Melzack in 1987 and the validity and reliability of the Turkish version has been demonstrated, the questionnaire is widely used to measure pain. This questionnaire consists of a total of 15 descriptive words to determine the sensory (11 words) and effective (4 words) characteristics of pain. In this section, pain intensity (0=absent, 1=mild, 2=moderate, 3=severe) is assessed to arrive at three pain scores (sensory, effective and total pain ratio = sensory + effective). In addition, the pain felt at the time of the measurement is calculated with the Visual Analog Scale (VAS) and the total pain intensity is calculated with a 6-point Likert scale. In this scale, 0: no pain, 1: mild, 2: uncomfortable, 3: distressing, 4: terrible, 5: unbearable pain.
Measured: 3 mounths
Central Sensitization Scale
The Central Sensitization Scale consists of 2 parts, parts A and B. Symptoms associated with central sensitization in section A is questioned. These symptoms include sensitivity to smell, light, chemical stimuli, headache, full body pain, neck and shoulder tension, muscle stiffness and pain, skin itching/redness, depressive features, waking up restless, restless legs before sleep, sleep disturbance, low energy, anxiety attacks, impaired concentration, memory problems, worsening of symptoms with stress, frequent urge to urinate, bladder discomfort, diarrhea/constipation problems and pelvic pain. Section A contains 25 items with a total score range of 0-100. For each item in this section, one of the following responses is given: "never" (0 points), "rarely" (1 point), "sometimes" (2 points), "often" (3 points), "always" (4 points). A score of 40 and above indicates the presence of central sensitization.
In section B, it is questioned whether the patient has been diagnosed with another.
Measured: 3 mounths
Time Up and Go Test
The balance status of the individual is evaluated by getting up from a chair with back support, walking 3 meters at a normal walking speed and returning back to the chair and the time he/she sits on the chair is measured and recorded in seconds.The test is repeated 3 times.
Measured: 3 mounths
6 min Walk Test
It will be used to assess the functional capacity of the patients. Patients will be asked to walk as long as possible in a 20-meter hospital corridor for 6 minutes in their own rhythm and with standard commands and the distance walked will be recorded in meters.
Measured: 3 mounths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start12 Jul 2025 (estimated)
- Primary completion30 Aug 2025 (estimated)
- Study completion12 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cognitive Exercise Therapy Approach (Bilişsel Egzersiz Terapi Yaklaşımı - BETY)
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aysima Barlak
- Sponsor type
- University, hospital or other
- Collaborators
- Alanya Alaaddin Keykubat University, Alanya Alaaddin Keykubat University Alanya Training and Research Hospital
- Responsible party
- Sponsor-investigator, Aysima Barlak, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034417
- Sponsor's protocol ID
- 03-03
- Status last verified
- Feb 2025
- First submitted
- 18 Mar 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation The Effectiveness Of Cognitive Exercise Therapy Approach (Bilişsel Egzersiz Terapi Yaklaşımı - BETY) In Individuals With Fibromyalgia
- ClinicalTrials.gov ID
- NCT07034417
- Acronym / sponsor ID
- 03-03
- Conditions
- Fibromyalgia
- Keywords
- biopsychosocial model, pain, functional capacity, depression, anxiety, quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aysima BarlakUniversity, hospital or other
- Collaborators
- Alanya Alaaddin Keykubat University, Alanya Alaaddin Keykubat University Alanya Training and Research Hospital
- Study start
- 12 Jul 2025 (estimated)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 12 Feb 2027 (estimated)
- First posted
- 24 Jun 2025 (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.
Fibromyalgia Syndrome (FMS) is a nonarticular, chronic rheumatic disorder of unknown etiology characterized by widespread musculoskeletal pain, impaired sleep quality, fatigue and the presence of identified tender points. Pain, the main symptom of the disease, is described as chronic and widespread. It is reported that the pain usually starts in the neck and shoulders but becomes widespread by being felt in various parts of the body during the day. Although it is difficult to localize the pain, it is reported to be localized to the paracervical and trapezius muscle and paralumbar and gluteal body parts.
Cognitive Exercise Therapy Approach is an innovative exercise approach developed on the basis of biopsychosocial model on individuals with rheumatism. This method has a unique scale that offers biopsychosocial assessment. There is the Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire (BETY-BQ). Validity, reliability and sensitivity studies of BETY-BQ have been conducted in individuals with fibromyalgia. This study aims to examine the effect of BETY, an exercise approach developed on the basis of the biopsychosocial model, on individuals with fibromyalgia.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cognitive Exercise Therapy Approach (Bilişsel Egzersiz Terapi Yaklaşımı - BETY)
| Arm | Type | Receives |
|---|---|---|
| BETY Group | Experimental | Other: ExerciseBETY exercise sessions |
| Control Group | Other | Other: Home exerciseHome exercise program |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being diagnosed with fibromyalgia
- 18 years of age or older
- Being literate
- Having read and signed the informed consent
- Not exercising regularly in the last 3 months
Key exclusion criteria (7 listed)
- Having a malignant disease
- Pregnancy
- Having chronic infectious or other rheumatologic diseases
- Having undergone a surgical operation in the last 6 months
- Collagen tissue disease
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 |
|---|---|---|
| ExerciseCognitive Exercise Therapy Approach | Other | BETY Group |
| Home exerciseHome exercise | Other | Control Group |
Primary outcome
Cognitive Exercise Therapy Approach (BETY)- Biopsychosocial Questionnaire
Time frame: 3 mounths
The BETY Questionnaire was developed on rheumatic patients and was introduced to the literature as a standardized biopsychosocial measurement tool as a result of improving the definitions of recovery from patients with expert opinions and statistical analysis. Scoring of the scale is done using a 5-point Likert system, each item is scored between 0 and 4 points, and a high total score in the scale consisting of a total of 30 items indicates a high biopsychosocial impact.
12 secondary outcomes
Hospital Anxiety Depression Scale (HADS)
Time frame: 3 mounths
Health Asessement Questionnaire (HAQ)
Time frame: 3 mounths
Short Form - 36
Time frame: 3 mounths
Pain Catastrophizing Scale
Time frame: 3 mounths
Fatigue Severity Scale
Time frame: 3 mounths
Tampa Scale of Kinesiophobia
Time frame: 3 mounths
Fibromyalgia Impact Questionnaire
Time frame: 3 mounths
Brief Illness Perception Questionnaire
Time frame: 3 mounths
McGill Pain Questionnaire Short Form
Time frame: 3 mounths
Central Sensitization Scale
Time frame: 3 mounths
Time Up and Go Test
Time frame: 3 mounths
6 min Walk Test
Time frame: 3 mounths
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 24 Jun 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Home exercise in people with Fibromyalgia, run by Aysima Barlak at 1 site in Turkey (Türkiye).
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 5 inclusion and 7 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 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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 Kübra Sargın Baskın, PT, MSc (5335664516, kubrasbaskin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Exercise Therapy Approach (BETY)- Biopsychosocial Questionnaire (time frame: 3 mounths). 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 24 Jun 2025.