NCT07591766

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 6, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2023

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 18, 2026

Completed
Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

8 months

First QC Date

May 5, 2026

Last Update Submit

May 15, 2026

Conditions

Keywords

fibromyalgiaAerobic ExercisepainQuality of LifePhysical Activity

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    change from baseline at 8 weeks

Secondary Outcomes (5)

  • Short Form-36 Health Survey (SF-36)

    change from baseline at 8 weeks

  • Pittsburgh Sleep Quality Index

    change from baseline at 8 weeks

  • Beck Depression Inventory

    change from baseline at 8 weeks

  • International Physical Activity Questionnaire-Short Form

    change from baseline at 8 weeks

  • Fatigue Severity Scale

    change from baseline at 8 weeks

Study Arms (2)

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.

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.

Other: Conventional Exercises

Interventions

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.

Aerobic Dance 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.

Conventional Exercises

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

FibromyalgiaPainMotor Activity

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

May 5, 2026

First Posted

May 18, 2026

Study Start

May 6, 2022

Primary Completion

January 6, 2023

Study Completion

May 6, 2023

Last Updated

May 18, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations