- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03978975
Water Exercise and Health (WATHEALTH) (WATHEALTH)
Effect of Water Temperature on Energy Response During Aquatic Cycling in Women: Impact of Weight Status
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
After inclusion visit, all subject will be submitted to DXA to obtain body composition data. Then subjects will be submitted to four experimental session in a semi-randomized order. For all those session, subjects will take a standardized breakfast (570kcal) three hours before experimental session.
Control session (CON): subject will stand sited without any activity during 40 min.
Subjects will be submitted to three aquatic cycling exercise session:
- session 27°C :aquatic cycling at 27°C without water jet during 40 min
- session 27°C+ water jets : aquatic cycling at 27 °C with water jets during 40 min
- session 18°C : aquatic cycling at 187°C without water jet during 40 min Every exercise session will be set at 70% of theorical maximal heart rate During each session, oxygen consumption and carbon dioxide production will be analysed with gas analysis system. Appetite and hunger sensation will be measured with a specific scale at different time point of each day of experimental session. Thirty minutes after the end of each experimental session subjects will have a buffet meal for lunch time.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Clermont-Ferrand, Francia, 63000
- Reclutamiento
- CHU clermont-ferrand
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Contacto:
- Lise Laclautre
- Correo electrónico: drci@chu-clermontferrand.fr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Women aged between 20 and 40 years
- BMI under 25kg.m2 for normal weight women and between 25 and 29,9 kg.m2 for overweight women
- Daily breakfast
- Subject which approved informed consent
- Subject with French medical affiliation
Exclusion Criteria:
- Specific medical treatment
- Aquaphobia
- Subject under specific diet regimen or weight loss program
- Subject with cardio-vascular disease
- Surgical intervention less than 3 months
- Subject refusing informed and written consent
- Subject without French medical affiliation
- subject refusing inscription to the national voluntary list
- subject being in an exclusion period
- subject smoking or drinking alcohol frequently
- subject with intense physical activity
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: normal weight women
20 women with a body mass index ranging between 18,5 and 24,9 kg.m2
|
For all those session, subjects will take a standardized breakfast (570kcal) three hours before experimental session. Control session (CON): subject will stand sited without any activity during 40 min. Subjects will be submitted to three aquatic cycling exercise session:
|
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Experimental: overweight women
20 women with a body mass index ranging between 25 and 29,9 kg.m2
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For all those session, subjects will take a standardized breakfast (570kcal) three hours before experimental session. Control session (CON): subject will stand sited without any activity during 40 min. Subjects will be submitted to three aquatic cycling exercise session:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Food intake during buffet meal 30 minutes after the end of experimental session
Periodo de tiempo: Day 7
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total energy intake at the post session lunch will be calculated by measuring food intake
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Day 7
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Food intake during buffet meal 30 minutes after the end of experimental session
Periodo de tiempo: Day 14
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total energy intake at the post session lunch will be calculated by measuring food intake
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Day 14
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Food intake during buffet meal 30 minutes after the end of experimental session
Periodo de tiempo: Day 21
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total energy intake at the post session lunch will be calculated by measuring food intake
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Day 21
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Food intake during buffet meal 30 minutes after the end of experimental session
Periodo de tiempo: Day 28
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total energy intake at the post session lunch will be calculated by measuring food intake
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Day 28
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Appetite, hunger and satiety
Periodo de tiempo: Day 7
|
using a visual analog scale from 0 millimeter (no sensation) to 100mm (highest sensation)
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Day 7
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Appetite, hunger and satiety
Periodo de tiempo: Day 14
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using a visual analog scale from 0 millimeter (no sensation) to 100mm (highest sensation)
|
Day 14
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|
Appetite, hunger and satiety
Periodo de tiempo: Day 21
|
using a visual analog scale from 0 millimeter (no sensation) to 100mm (highest sensation)
|
Day 21
|
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Appetite, hunger and satiety
Periodo de tiempo: Day 28
|
using a visual analog scale from 0 millimeter (no sensation) to 100mm (highest sensation)
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Day 28
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Energy expenditure
Periodo de tiempo: Day 7
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with a gas analyser energy expenditure will be measured in kcal
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Day 7
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Energy expenditure
Periodo de tiempo: Day 14
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with a gas analyser energy expenditure will be measured in kcal
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Day 14
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Energy expenditure
Periodo de tiempo: Day 21
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with a gas analyser energy expenditure will be measured in kcal
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Day 21
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Energy expenditure
Periodo de tiempo: Day 28
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with a gas analyser energy expenditure will be measured in kcal
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Day 28
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Perceived exertion
Periodo de tiempo: Day 7
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using Borg scale perceived exertion will be evaluated between 6 (very light) and 20 (extremely difficult)
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Day 7
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Perceived exertion
Periodo de tiempo: Day 14
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using Borg scale perceived exertion will be evaluated between 6 (very light) and 20 (extremely difficult)
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Day 14
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Perceived exertion
Periodo de tiempo: Day 21
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using Borg scale perceived exertion will be evaluated between 6 (very light) and 20 (extremely difficult)
|
Day 21
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Perceived exertion
Periodo de tiempo: Day 28
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using Borg scale perceived exertion will be evaluated between 6 (very light) and 20 (extremely difficult)
|
Day 28
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RBHP 2018 DUCLOS 4 (Wathealth)
- 2019-A00353-54 (Otro identificador: ANSM)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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