Aerobic Dance Exercises in Fibromyalgia Syndrome

May 15, 2026 updated by: Tugba Civi Karaaslan, Istanbul University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • unstable angina pectoris with severe dyspnea that would prevent exercise
  • the presence of any neurological or orthopedic disease other than FMS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Aerobic Dance Exercises
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.
Other: Aerobic Dance Exercises
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.
Experimental: Conventional Exercises
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.
Other: Conventional Exercises
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
change from baseline at 8 weeks
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
change from baseline at 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Short Form-36 Health Survey (SF-36)
Time Frame: change from baseline at 8 weeks
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.
change from baseline at 8 weeks
Pittsburgh Sleep Quality Index
Time Frame: change from baseline at 8 weeks
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.
change from baseline at 8 weeks
Beck Depression Inventory
Time Frame: change from baseline at 8 weeks
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.
change from baseline at 8 weeks
International Physical Activity Questionnaire-Short Form
Time Frame: change from baseline at 8 weeks
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.
change from baseline at 8 weeks
Fatigue Severity Scale
Time Frame: change from baseline at 8 weeks
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.
change from baseline at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 6, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 6, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 6, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IstanbulUC4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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