Fibromyalgia (FM)NCT07591766
Aerobic Dance Exercises in Fibromyalgia Syndrome
A study testing Aerobic Dance Exercises and Conventional Exercises in people with Fibromyalgia (FM) and Fibromyalgia Syndrome, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate the effects of aerobic dance exercises on patients with Fibromyalgia syndrome (FMS) and to compare these effects with those of conventional postural exercises. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia (FM), Fibromyalgia Syndrome, Fibromyalgia
- What is being tested?
- Aerobic Dance Exercises and Conventional Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 May 2022to 6 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of FMS according to the American College of Rheumatology (ACR) diagnostic criteria
- being female between the ages of 18 and 65
- having the physical capacity to exercise
Who cannot join
- unstable angina pectoris with severe dyspnea that would prevent exercise
- the presence of any neurological or orthopedic disease other than FMS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Aerobic Dance Exercises in Fibromyalgia Syndrome: A Randomized Controlled Trial
The aim of this study was to evaluate the effects of aerobic dance exercises on patients with Fibromyalgia syndrome (FMS) and to compare these effects with those of conventional postural exercises.
Read the detailed description
The aim of this study was to evaluate the effects of aerobic dance exercises on patients with Fibromyalgia syndrome (FMS) and to compare these effects with those of conventional postural exercises. A total of 44 female participants were included. Group-1 (n=22) received aerobic dance exercises twice a week for eight weeks, while Group-2 (n=22) was given a conventional postural exercise program as a home-based intervention with the same duration and frequency. To evaluate the participants, the following assessment tools were used: Fibromyalgia Impact Questionnaire, McGill-Melzack Pain Questionnaire, Short Form-36, Pittsburgh Sleep Quality Index, Beck Depression Inventory, International Physical Activity Questionnaire-Short Form, and Fatigue Severity Scale. Both groups showed significant improvements in nearly all parameters after the intervention (p<0.05).
- Conditions
- Fibromyalgia (FM), Fibromyalgia Syndrome, Fibromyalgia
- Being tested
- Aerobic Dance Exercises, Conventional Exercises
- Keywords
- fibromyalgia, Aerobic Exercise, pain, Quality of Life, Physical Activity
- Medical subject headings
- Fibromyalgia, Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Dance ExercisesOther
The aerobic protocol for Group-1 was divided into four distinct phases: warm-up, endurance training, stretching, and cooling down. These sessions were led by a physiotherapist in groups of five, using music to guide the exercise rhythm. Initial warm-ups lasted 5 to 7 minutes and involved stationary marching and stepping patterns. A 20-minute core segment followed, featuring group dance movements that incorporated various torso and limb rotations. Cardiovascular challenge was integrated through 5 minutes of rapid-paced dance. The program ended with a 5-minute cool-down period where participants gradually reduced their activity level in alignment with a slowing musical tempo.
Conventional ExercisesOther
To improve muscle balance and protect spinal integrity, Group-2 performed conventional posture exercises targeting the neck, back, core, and shoulders. This routine, a common clinical approach for individuals with FMS, was conducted as a home-based program with a frequency of two sessions per week. To ensure compliance and track progress, each participant utilized a dedicated exercise diary to record their activities throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Dance Exercises | Experimental | The aerobic protocol for Group-1 was divided into four distinct phases: warm-up, endurance training, stretching, and cooling down. These sessions were led by a physiotherapist in groups of five, using music to guide the exercise rhythm. Initial warm-ups lasted 5 to 7 minutes and involved stationary marching and stepping patterns. A 20-minute core segment followed, featuring group dance movements that incorporated various torso and limb rotations. Cardiovascular challenge was integrated through 5 minutes of rapid-paced dance. The program ended with a 5-minute cool-down period where participants gradually reduced their activity level in alignment with a slowing musical tempo. Receives: Other: Aerobic Dance Exercises |
| Conventional Exercises | Experimental | To improve muscle balance and protect spinal integrity, Group-2 performed conventional posture exercises targeting the neck, back, core, and shoulders. This routine, a common clinical approach for individuals with FMS, was conducted as a home-based program with a frequency of two sessions per week. To ensure compliance and track progress, each participant utilized a dedicated exercise diary to record their activities throughout the study. Receives: Other: Conventional Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibromyalgia Impact Scale
To measure the impact of the disease on daily life, a 20-question assessment tool was utilized, focusing on domains such as physical capacity, occupational health, and psychological well-being. Additionally, the scale screens for pain intensity, stiffness, sleep quality, and overall vitality. The scoring system is structured such that higher results indicate more pronounced symptoms and lower functional capacity, while lower scores reflect better health status. Total scores range from 0 to 100, with higher scores indicating greater disease impact and poorer functional status.
Measured: change from baseline at 8 weeks
McGill-Melzack Pain Scale
To characterize the nature and intensity of the pain, the McGill-Melzack scale was utilized. This assessment encompasses a detailed analysis of pain topography, its sensory qualities, and duration. It also accounts for specific triggers or modifiers of pain frequency. Scoring is interpreted such that higher cumulative values reflect more profound pain symptoms and increased clinical severity.Total scores range from 0 to 78, with higher scores indicating greater pain severity and pain-related distress
Measured: change from baseline at 8 weeks
Secondary outcomes (5)
Short Form-36 Health Survey (SF-36)
The Short Form-36 Health Survey is a comprehensive 36-item questionnaire used to assess health-related quality of life, including physical functioning, psychosocial functioning, pain, and mental health status. Each subscale is scored on a scale ranging from 0 to 100, with higher scores indicating better functional status and improved overall health-related quality of life.
Measured: change from baseline at 8 weeks
Pittsburgh Sleep Quality Index
The PSQI was utilized to measure participants' self-reported sleep quality and related disturbances. The scale comprises 19 items that form seven sub-scores, which are then aggregated into a single global score between 0 and 21. While lower scores are indicative of better sleep quality, a cumulative score higher than five is clinically interpreted as a sign of significant sleep dysfunction.
Measured: change from baseline at 8 weeks
Beck Depression Inventory
To evaluate participants' depressive states, the BDI, which consists of 21 questions, was utilized. Each item is scored between 0 and 3, and the total score is used to determine the intensity of the symptoms. Clinical classifications were made based on the total score: 0-9 points as no depression, 10-16 points as mild, 17-23 points as moderate, and any value 24 or above as severe depression.
Measured: change from baseline at 8 weeks
International Physical Activity Questionnaire-Short Form
The International Physical Activity Questionnaire-Short Form will be used to assess participants' physical activity levels. The questionnaire evaluates the frequency and duration of walking, moderate-intensity activity, vigorous-intensity activity, and sedentary behavior over the last 7 days. Total physical activity is calculated in metabolic equivalent (MET)-minutes/week. Higher scores indicate higher levels of physical activity.
Measured: change from baseline at 8 weeks
Fatigue Severity Scale
To evaluate the impact of fatigue, the FSS, which views fatigue severity as a single-dimensional construct, was administered. Participants responded to nine statements using a scoring range from 1 to 7. The overall fatigue score was derived from the average of these ratings; consequently, an increase in the total score indicates a greater level of perceived fatigue.
Measured: change from baseline at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start6 May 2022
- Primary completion6 Jan 2023
- Study completion6 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia (FM)Studies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugba Civi Karaaslan, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07591766
- Sponsor's protocol ID
- IstanbulUC4
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 18 May 2026
- 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 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Aerobic Dance Exercises in Fibromyalgia Syndrome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07591766
- Acronym / sponsor ID
- IstanbulUC4
- Conditions
- Fibromyalgia (FM), Fibromyalgia Syndrome, Fibromyalgia
- Keywords
- fibromyalgia, Aerobic Exercise, pain, Quality of Life, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 6 May 2022 (actual)
- Primary completion
- 6 Jan 2023 (actual)
- Study completion
- 6 May 2023 (actual)
- First posted
- 18 May 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.
The aim of this study was to evaluate the effects of aerobic dance exercises on patients with Fibromyalgia syndrome (FMS) and to compare these effects with those of conventional postural exercises.
Detailed description
The aim of this study was to evaluate the effects of aerobic dance exercises on patients with Fibromyalgia syndrome (FMS) and to compare these effects with those of conventional postural exercises. A total of 44 female participants were included. Group-1 (n=22) received aerobic dance exercises twice a week for eight weeks, while Group-2 (n=22) was given a conventional postural exercise program as a home-based intervention with the same duration and frequency. To evaluate the participants, the following assessment tools were used: Fibromyalgia Impact Questionnaire, McGill-Melzack Pain Questionnaire, Short Form-36, Pittsburgh Sleep Quality Index, Beck Depression Inventory, International Physical Activity Questionnaire-Short Form, and Fatigue Severity Scale. Both groups showed significant improvements in nearly all parameters after the intervention (p<0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Dance Exercises | Experimental | Other: Aerobic Dance ExercisesThe aerobic protocol for Group-1 was divided into four distinct phases: warm-up, endurance training, stretching, and cooling down. These sessions were led by a physiotherapist in groups of five, using music to guide the exercise rhythm. Initial warm-ups lasted 5 to 7 minutes and involved stationary marching and stepping patterns. A 20-minute core segment followed, featuring group dance movements that incorporated various torso and limb rotations. Cardiovascular challenge was integrated through 5 minutes of rapid-paced dance. The program ended with a 5-minute cool-down period where participants gradually reduced their activity level in alignment with a slowing musical tempo. |
| Conventional Exercises | Experimental | Other: Conventional ExercisesTo improve muscle balance and protect spinal integrity, Group-2 performed conventional posture exercises targeting the neck, back, core, and shoulders. This routine, a common clinical approach for individuals with FMS, was conducted as a home-based program with a frequency of two sessions per week. To ensure compliance and track progress, each participant utilized a dedicated exercise diary to record their activities throughout the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of FMS according to the American College of Rheumatology (ACR) diagnostic criteria
- being female between the ages of 18 and 65
- having the physical capacity to exercise
Key exclusion criteria (2 listed)
- unstable angina pectoris with severe dyspnea that would prevent exercise
- the presence of any neurological or orthopedic disease other than FMS
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 |
|---|---|---|
| Aerobic Dance ExercisesThe aerobic protocol for Group-1 was divided into four distinct phases: warm-up, endurance training, stretching, and cooling down. These sessions were led by a physiotherapist in groups of five, using music to guide the exercise rhythm. Initial warm-ups lasted 5 to 7 minutes and involved stationary marching and stepping patterns. A 20-minute core segment followed, featuring group dance movements that incorporated various torso and limb rotations. Cardiovascular challenge was integrated through 5 minutes of rapid-paced dance. The program ended with a 5-minute cool-down period where participants gradually reduced their activity level in alignment with a slowing musical tempo. | Other | Aerobic Dance Exercises |
| Conventional ExercisesTo improve muscle balance and protect spinal integrity, Group-2 performed conventional posture exercises targeting the neck, back, core, and shoulders. This routine, a common clinical approach for individuals with FMS, was conducted as a home-based program with a frequency of two sessions per week. To ensure compliance and track progress, each participant utilized a dedicated exercise diary to record their activities throughout the study. | Other | Conventional Exercises |
Primary outcome
Fibromyalgia Impact Scale
Time frame: change from baseline at 8 weeks
To measure the impact of the disease on daily life, a 20-question assessment tool was utilized, focusing on domains such as physical capacity, occupational health, and psychological well-being. Additionally, the scale screens for pain intensity, stiffness, sleep quality, and overall vitality. The scoring system is structured such that higher results indicate more pronounced symptoms and lower functional capacity, while lower scores reflect better health status. Total scores range from 0 to 100, with higher scores indicating greater disease impact and poorer functional status.
McGill-Melzack Pain Scale
Time frame: change from baseline at 8 weeks
To characterize the nature and intensity of the pain, the McGill-Melzack scale was utilized. This assessment encompasses a detailed analysis of pain topography, its sensory qualities, and duration. It also accounts for specific triggers or modifiers of pain frequency. Scoring is interpreted such that higher cumulative values reflect more profound pain symptoms and increased clinical severity.Total scores range from 0 to 78, with higher scores indicating greater pain severity and pain-related distress
5 secondary outcomes
Short Form-36 Health Survey (SF-36)
Time frame: change from baseline at 8 weeks
Pittsburgh Sleep Quality Index
Time frame: change from baseline at 8 weeks
Beck Depression Inventory
Time frame: change from baseline at 8 weeks
International Physical Activity Questionnaire-Short Form
Time frame: change from baseline at 8 weeks
Fatigue Severity Scale
Time frame: change from baseline at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Dance Exercises and Conventional Exercises in people with Fibromyalgia (FM) and Fibromyalgia Syndrome, run by Istanbul University 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 18 May 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibromyalgia Impact Scale (time frame: change from baseline at 8 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 18 May 2026.