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- Ensayo clínico NCT07591766
Aerobic Dance Exercises in Fibromyalgia Syndrome
15 de mayo de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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).
Tipo de estudio
Intervencionista
Inscripción (Actual)
44
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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-
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Istanbul, Turquía (Türkiye)
- Istanbul University-Cerrahpaşa
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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.
|
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.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Fibromyalgia Impact Scale
Periodo de tiempo: 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.
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change from baseline at 8 weeks
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McGill-Melzack Pain Scale
Periodo de tiempo: 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
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change from baseline at 8 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Short Form-36 Health Survey (SF-36)
Periodo de tiempo: 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.
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change from baseline at 8 weeks
|
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Pittsburgh Sleep Quality Index
Periodo de tiempo: 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.
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change from baseline at 8 weeks
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Beck Depression Inventory
Periodo de tiempo: 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.
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change from baseline at 8 weeks
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International Physical Activity Questionnaire-Short Form
Periodo de tiempo: 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.
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change from baseline at 8 weeks
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Fatigue Severity Scale
Periodo de tiempo: 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.
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change from baseline at 8 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
6 de mayo de 2022
Finalización primaria (Actual)
6 de enero de 2023
Finalización del estudio (Actual)
6 de mayo de 2023
Fechas de registro del estudio
Enviado por primera vez
5 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
15 de mayo de 2026
Publicado por primera vez (Actual)
18 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
15 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IstanbulUC4
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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