- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07607795
Effect of Isometric Handgrip Exercise on Blood Pressure in Pregnant Women (GRIP4HEALTH)
21 maj 2026 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
30
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Carina ENEA
- Telefonnummer: +33 549 454 495
- E-post: carina.enea@univ-poitiers.fr
Studera Kontakt Backup
- Namn: Mélanie Gréau Marias
- Telefonnummer: +33 675 329 599
- E-post: melanie.greau.marias@univ-poitiers.fr
Studieorter
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Poitiers, Frankrike, 86000
- Rekrytering
- Faculty of Sport Science - MOVE Laboratory - UR 20296
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Kontakt:
- Mélanie Gréau Marias
- Telefonnummer: +33 675 329 599
- E-post: melanie.greau.marias@univ-poitiers.fr
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Ja
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Övrig: 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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Övrig: 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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Systoliskt och diastoliskt blodtryck (ambulatorisk blodtrycksmätning)
Tidsram: Efter sessioner (24 timmar)
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Hypotoni efter träning, med hjälp av Mobil-O-Graph (mmHg).
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Efter sessioner (24 timmar)
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Systolic and diastolic blood pressure (resting)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
6 mars 2026
Primärt slutförande (Beräknad)
31 augusti 2027
Avslutad studie (Beräknad)
30 september 2027
Studieregistreringsdatum
Först inskickad
6 maj 2026
Först inskickad som uppfyllde QC-kriterierna
21 maj 2026
Första postat (Faktisk)
26 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
26 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
21 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2025-A00590-49
Plan för individuella deltagardata (IPD)
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NEJ
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Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
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Nej
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