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- Essai clinique NCT07607795
Effect of Isometric Handgrip Exercise on Blood Pressure in Pregnant Women (GRIP4HEALTH)
21 mai 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
30
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Carina ENEA
- Numéro de téléphone: +33 549 454 495
- E-mail: carina.enea@univ-poitiers.fr
Sauvegarde des contacts de l'étude
- Nom: Mélanie Gréau Marias
- Numéro de téléphone: +33 675 329 599
- E-mail: melanie.greau.marias@univ-poitiers.fr
Lieux d'étude
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Poitiers, France, 86000
- Recrutement
- Faculty of Sport Science - MOVE Laboratory - UR 20296
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Contact:
- Mélanie Gréau Marias
- Numéro de téléphone: +33 675 329 599
- E-mail: melanie.greau.marias@univ-poitiers.fr
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Oui
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Autre: 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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Autre: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Pression artérielle systolique et diastolique (mesure ambulatoire de la pression artérielle)
Délai: Après les séances (24 heures)
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Hypotension post-exercice, à l'aide du Mobil-O-Graph (mmHg).
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Après les séances (24 heures)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Systolic and diastolic blood pressure (resting)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
6 mars 2026
Achèvement primaire (Estimé)
31 août 2027
Achèvement de l'étude (Estimé)
30 septembre 2027
Dates d'inscription aux études
Première soumission
6 mai 2026
Première soumission répondant aux critères de contrôle qualité
21 mai 2026
Première publication (Réel)
26 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
26 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
21 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2025-A00590-49
Plan pour les données individuelles des participants (IPD)
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NON
Informations sur les médicaments et les dispositifs, documents d'étude
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Non
Étudie un produit d'appareil réglementé par la FDA américaine
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