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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07607795
Effect of Isometric Handgrip Exercise on Blood Pressure in Pregnant Women (GRIP4HEALTH)
21 de mayo de 2026 actualizado por: Carina Enea, University of Poitiers
Effect of Isometric Handgrip Exercise on Cardiovascular and Cognitive Responses in Normotensive and Hypertensive Pregnant Women (GRIP4HEALTH)
Hypertension during pregnancy is a major public health concern, increasing the risk of cardiovascular complications for both the mother and the fetus.
Women with chronic hypertension are at higher risk of adverse outcomes, and elevated blood pressure during pregnancy has also been associated with long-term cardiovascular and cognitive impairments.Regular physical activity is recognized as an effective non-pharmacological strategy to reduce blood pressure.
Among different exercise modalities, isometric exercise has shown promising effects in lowering blood pressure in the general population, with minimal cardiovascular strain.
However, its effects and safety in pregnant women, particularly those with hypertension, remain poorly understood.In addition to cardiovascular alterations, hypertension during pregnancy may also impact cognitive function, potentially through changes in cerebral perfusion and vascular function.
Despite these associations, the combined cardiovascular and cognitive responses to exercise in this population have not been fully explored.This study aims to investigate the effects of isometric handgrip exercise on cardiovascular and cognitive responses in pregnant women with and without chronic hypertension, in order to better understand its potential as a safe and effective non-pharmacological intervention during pregnancy.
Descripción general del estudio
Estado
Reclutamiento
Intervención / Tratamiento
Descripción detallada
Hypertension during pregnancy is a major public health concern associated with increased maternal and fetal morbidity, and long-term cardiovascular risk.
Women with chronic hypertension are at higher risk of complications such as preeclampsia, preterm birth, and adverse neonatal outcomes.
In addition, growing evidence suggests that hypertensive disorders of pregnancy may also be associated with long-term alterations in cardiovascular function and cognitive performance.During pregnancy, physiological changes in blood pressure regulation and vascular function may further complicate the management of hypertension.
Pharmacological treatment options are limited due to potential risks for the fetus, highlighting the need for safe and effective non-pharmacological strategies.Physical exercise is recognized as an effective approach to reduce blood pressure and improve cardiovascular health in the general population.
Among the different exercise modalities, isometric exercise has shown particularly promising effects in reducing blood pressure, with a low cardiovascular load.
This modality may therefore represent an attractive option for pregnant women, as it can be performed safely with minimal physiological stress.
However, despite these potential benefits, the effects and safety of isometric exercise during pregnancy, particularly in hypertensive women, remain poorly understood.In addition to cardiovascular alterations, hypertension during pregnancy may impact cognitive function, potentially through changes in cerebral perfusion and vascular regulation.
Although physical activity has been associated with improvements in cognitive performance in the general population, the acute effects of exercise on cognitive function during pregnancy have not been well established.The aims of this study are:First, to evaluate the effect of isometric handgrip exercise on 24-hour blood pressure in pregnant women with and without chronic hypertension.Second, to compare cardiovascular responses to isometric exercise between normotensive and hypertensive pregnant women, including brachial and central blood pressure, arterial stiffness, and heart rate.Third, to examine differences in cognitive performance between normotensive and hypertensive pregnant women, and to explore the relationship between cardiovascular responses and cognitive outcomes.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
30
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: Carina ENEA
- Número de teléfono: +33 549 454 495
- Correo electrónico: carina.enea@univ-poitiers.fr
Copia de seguridad de contactos de estudio
- Nombre: Mélanie Gréau Marias
- Número de teléfono: +33 675 329 599
- Correo electrónico: melanie.greau.marias@univ-poitiers.fr
Ubicaciones de estudio
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Poitiers, Francia, 86000
- Reclutamiento
- Faculty of Sport Science - MOVE Laboratory - UR 20296
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Contacto:
- Mélanie Gréau Marias
- Número de teléfono: +33 675 329 599
- Correo electrónico: melanie.greau.marias@univ-poitiers.fr
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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
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Pregnant women covered by the French National Health Insurance system
- Pregnant women who do not object to participation in the study
- Women belonging to one of the following two groups:
- Women with chronic hypertension present before pregnancy (diagnosed within the past 5 years), defined as systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg, without antihypertensive treatment
- Normotensive pregnant women, defined as systolic blood pressure (SBP) < 140 mmHg and diastolic blood pressure (DBP) < 90 mmHg before pregnancy
Exclusion Criteria:
- Current treatment for chronic or gestational hypertension
- Known cardiovascular disease other than chronic hypertension
- Age under 18 years
- Persons deprived of liberty
- Inability to speak or adequately understand French
- Persons hospitalized without consent who are not subject to legal protection measures, and persons admitted to a health or social institution for purposes other than research
- Persons currently excluded from participation in another research study
- Persons under judicial protection or guardianship Type 1 or type 2 diabetes
- Severe or extreme obesity (BMI ≥ 40 kg/m²)
- Thyroid disease
- Heavy smoking
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: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: Normotensive Pregnant Women
Pregnant women without chronic hypertension.
Participants in this arm complete both the isometric handgrip exercise session and the control rest session in randomized order.
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Isometric handgrip exercise performed at 30% of maximal voluntary contraction, consisting of four 2-minute contractions with one-minute rest intervals between efforts.
The exercise is performed using a handgrip dynamometer.
Seated rest condition without exercise, used as a control comparison to the isometric handgrip intervention.
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Otro: Hypertensive Pregnant Women
Pregnant women with chronic untreated hypertension.
Participants in this arm complete both the isometric handgrip exercise session and the control rest session in randomized order.
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Isometric handgrip exercise performed at 30% of maximal voluntary contraction, consisting of four 2-minute contractions with one-minute rest intervals between efforts.
The exercise is performed using a handgrip dynamometer.
Seated rest condition without exercise, used as a control comparison to the isometric handgrip intervention.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Presión arterial sistólica y diastólica (medición ambulatoria de la presión arterial)
Periodo de tiempo: Después de las sesiones (24 horas)
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Hipotensión post-ejercicio, utilizando el Mobil-O-Graph (mmHg).
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Después de las sesiones (24 horas)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Systolic and diastolic blood pressure (resting)
Periodo de tiempo: Before and after sessions (15 minutes)
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Automated oscillometric tensiometer (mmHg)
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Before and after sessions (15 minutes)
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Central blood pressure
Periodo de tiempo: Baseline and post-intervention during sessions (30 minutes)
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Central systolic and diastolic blood pressure assessed using pulse wave analysis derived from brachial oscillometric measurements.
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Baseline and post-intervention during sessions (30 minutes)
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Pulse wave velocity
Periodo de tiempo: Baseline
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Arterial stiffness assessed by carotid-femoral pulse wave velocity using applanation tonometry.
This measurement is performed at rest to characterize vascular health.
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Baseline
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Heart rate
Periodo de tiempo: Basline, before and after sessions (15 minutes)
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Heart rate measured during each experimental session and recovery period using a heart rate monitor to assess cardiovascular response to the intervention.
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Basline, before and after sessions (15 minutes)
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Cognitive Performance
Periodo de tiempo: Baseline
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Cognitive performance assessed at rest using a neuropsychological test battery including executive function, memory, attention, and processing speed tests. This outcome is used to compare cognitive function between normotensive and hypertensive pregnant women.
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Baseline
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
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 marzo de 2026
Finalización primaria (Estimado)
31 de agosto de 2027
Finalización del estudio (Estimado)
30 de septiembre de 2027
Fechas de registro del estudio
Enviado por primera vez
6 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
21 de mayo de 2026
Publicado por primera vez (Actual)
26 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
26 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
21 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
- 2025-A00590-49
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
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. .