- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07615829
Health Benefits of Dance Exercise
1 de julio de 2026 actualizado por: Dimitrios Draganidis, University of Thessaly
Effects of a 6-month Dance Exercise Intervention on Physical Performance, Metabolic and Mental Health in Pre- and Post-menopausal Women
In Greece, people of different age groups, including young children to older adults, participate in dance exercise training.
Although it is well-known that regular participation in dancing is associated with benefits such as entertainment, socialization and increased physical activity, the long-term effects of dancing on metabolic and mental health as well as physical performance remain largely unknown.
Therefore, the aim of this study is to investigate the effects of a 6-month dancing exercise intervention on metabolic and mental health and physical performance in premenopausal and postmenopausal women.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
Twenty premenopausal and twenty postmenopausal inactive women meeting the inclusion criteria will be randomly assigned to a Control (n=20) or an Experimental group (n=20).
The Control group will maintain their habitual physical activity level without participating in any form of exercise training.
The Experimental group will participate in two weekly dance exercise training sessions over a 6-month period.
Each session will be performed under supervision and include a 10-min warm up (2-3 dances of very slow tempo), a 45-min main dance exercise session (~15 dances of various tempos i.e. slow, moderate and fast tempo) and a 5-min cool-down period (walking and stretching).
Heart rate will be continuously monitored during each session by using heart rate monitors while the rate of perceived exertion (RPE) will be recorded at the end of each session.
In addition, prior to the second dance exercise session in each week, participants' delayed onset of muscle soreness (DOMS) and wellness status (through the wellness report) will be evaluated.
Prior to (Baseline) and after the intervention period (at 6 months) participants of both groups (Control and Experimental) will undergo resting blood sampling and assessment of their (i) anthropometrics, (ii) body composition, (iii) physical performance, (iv) physical activity level, (v) dietary intake, (vi) quality of life and (vii) mental health.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
40
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.
Estudio Contacto
- Nombre: Dimitrios Draganidis, PhD
- Número de teléfono: +30 2431047047
- Correo electrónico: ddraganidis@uth.gr
Copia de seguridad de contactos de estudio
- Nombre: Ioannis G Fatouros, PhD
- Número de teléfono: + 30 2431047047
- Correo electrónico: ifatouros@uth.gr
Ubicaciones de estudio
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Karies
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Trikala, Karies, Grecia, 42100
- Reclutamiento
- Department of Physical Education and Sport Science, University of Thessaly
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Contacto:
- Ioannis G Fatouros, PhD
- Número de teléfono: +30 24310 47047
- Correo electrónico: ifatouros@uth.gr
-
Contacto:
- Athanasios Z Jamurtas, PhD
- Número de teléfono: +30 2431047054
- Correo electrónico: ajamurt@uth.gr
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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
Sí
Descripción
Inclusion Criteria:
- Free of musculoskeletal injuries
- Free of chronic non-communicable diseases
- Normal menstrual cycle (for premenopausal women)
- No recent childbirth (previous 12 months) (for premenopausal women)
- At least 12 months since the oncet of menopause (for postmenopausal women)
- Non smokers
Exclusion Criteria:
- Pregnancy (for premenopausal women)
- Contraindications to exercise training
- Illness or other medical condition
- Use of medication
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: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Control Group
Participants in this group will maintain their habitual physical activity level without participating in any form of exercise training
|
It will include only habitual physical activity level without participating in any form of exercise training
|
|
Experimental: Experimental Group
Participants in this group will participate in two weekly dance exercise training sessions over a 6-month period
|
This intervention will consist of two weekly dance exercise training sessions over a 6-month period.
Each session will be performed under supervision and include a 10-min warm up (2-3 dances of very slow tempo), a 45-min main dance exercise session (~15 dances of various tempos i.e. slow, moderate and fast tempo) and a 5-min cool-down period (walking and stretching)
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in glucose concentration
Periodo de tiempo: At baseline and 6 months
|
Fasting glucose concentration will be determined in blood
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At baseline and 6 months
|
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Change in insulin concentration
Periodo de tiempo: At baseline and 6 months
|
Fasting insulin concentration will be determined in blood
|
At baseline and 6 months
|
|
Change in total cholesterol concentration
Periodo de tiempo: At baseline and 6 months
|
Total cholesterol concentration will be determined in blood
|
At baseline and 6 months
|
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Change in HDL cholesterol concentration
Periodo de tiempo: At baseline and 6 months
|
HDL cholesterol concentration will be determined in blood
|
At baseline and 6 months
|
|
Change in LDL cholesterol concentration
Periodo de tiempo: At baseline and 6 months
|
LDL cholesterol concentration will be determined in blood
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At baseline and 6 months
|
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Change in triglycerides concentration
Periodo de tiempo: At baseline and 6 months
|
Triglycerides concentration will be determined in blood
|
At baseline and 6 months
|
|
Change in serum glutamic-oxaloacetic transaminase (SGOT/AST) concentration
Periodo de tiempo: At baseline and 6 months
|
SGOT concentration will be determined in blood
|
At baseline and 6 months
|
|
Change in alanine aminotransferase (SGPT/ALT) concentration
Periodo de tiempo: At baseline and 6 months
|
SGPT concentration will be determined in blood
|
At baseline and 6 months
|
|
Change in gamma-glutamyl transpeptidase (γ-GT) concentration
Periodo de tiempo: At baseline and 6 months
|
γ-GT concentration will be determined in blood
|
At baseline and 6 months
|
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Change in body weight
Periodo de tiempo: At baseline and 6 months
|
At baseline and 6 months
|
|
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Change in waist circumference
Periodo de tiempo: At baseline and 6 months
|
At baseline and 6 months
|
|
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Change in hip circumference
Periodo de tiempo: At baseline and 6 months
|
At baseline and 6 months
|
|
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Change in cardiorespiratory fitness
Periodo de tiempo: At baseline and 6 months
|
Cardiorespiratory fitness will be assessed using the Ebbeling single stage treadmill test
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At baseline and 6 months
|
|
Change in muscle endurance
Periodo de tiempo: At baseline and 6 months
|
Muscle endurance will be assessed using the push-up and curl-up testing protocols
|
At baseline and 6 months
|
|
Change in resting blood pressure
Periodo de tiempo: At baseline and 6 months
|
Resting systolic and diastolic blood pressure will be assessed using a sphygmomanometer
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At baseline and 6 months
|
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Change in quality of life
Periodo de tiempo: At baseline and 6 months
|
Quality of life will be evaluated using questionnaire
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At baseline and 6 months
|
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Change in vitality
Periodo de tiempo: At baseline and 6 months
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Vitality will be evaluated using questionnaire
|
At baseline and 6 months
|
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Change in anxiety level
Periodo de tiempo: At baseline and 6 months
|
Anxiety will be evaluated using questionnaire
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At baseline and 6 months
|
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Change in flourishing
Periodo de tiempo: At baseline and 6 months
|
Flourishing will be evaluated using questionnaire
|
At baseline and 6 months
|
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Change in fat mass
Periodo de tiempo: At baseline and 6 months
|
Fat mass will be assessed using whole-body dual-energy X-ray absorptiometry (DXA)
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At baseline and 6 months
|
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Change in body fat percentage (%)
Periodo de tiempo: At baseline and 6 months
|
Body fat percentage (%) will be assessed using whole-body dual-energy X-ray absorptiometry (DXA)
|
At baseline and 6 months
|
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Change in fat free mass
Periodo de tiempo: At baseline and 6 months
|
Fat free mass will be assessed using whole-body dual-energy X-ray absorptiometry (DXA)
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At baseline and 6 months
|
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Change in lean body mass
Periodo de tiempo: At baseline and 6 months
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Lean body mass will be assessed using whole-body dual-energy X-ray absorptiometry (DXA)
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At baseline and 6 months
|
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Change in functional performance
Periodo de tiempo: At baseline and 6 months
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Functional performance will be assessed using the Short Physical Performance Battery
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At baseline and 6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in dietary intake
Periodo de tiempo: At baseline and 6 months
|
Dietary intake will be monitored using diet recalls
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At baseline and 6 months
|
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Change in daily number of steps
Periodo de tiempo: At baseline and 6 months
|
Daily number of steps performed will be assessed using accelerometers
|
At baseline and 6 months
|
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Change in daily time spent in moderate-to-vigorous physical activity
Periodo de tiempo: At baseline and 6 months
|
The time spent in moderate-to-vigorous physical activity will be assessed using accelerometers
|
At baseline and 6 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Maria Bougiesi, PhD, University of Thessaly, Department of Physical Education and Sport Science
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)
30 de mayo de 2026
Finalización primaria (Estimado)
30 de noviembre de 2026
Finalización del estudio (Estimado)
20 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
22 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
22 de mayo de 2026
Publicado por primera vez (Actual)
29 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
1 de julio de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UTH_2251_Long term
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
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .