- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07607795
Effect of Isometric Handgrip Exercise on Blood Pressure in Pregnant Women (GRIP4HEALTH)
May 21, 2026 updated by: 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.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Carina ENEA
- Phone Number: +33 549 454 495
- Email: carina.enea@univ-poitiers.fr
Study Contact Backup
- Name: Mélanie Gréau Marias
- Phone Number: +33 675 329 599
- Email: melanie.greau.marias@univ-poitiers.fr
Study Locations
-
-
-
Poitiers, France, 86000
- Recruiting
- Faculty of Sport Science - MOVE Laboratory - UR 20296
-
Contact:
- Mélanie Gréau Marias
- Phone Number: +33 675 329 599
- Email: melanie.greau.marias@univ-poitiers.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: 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.
|
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.
|
|
Other: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Systolic and diastolic blood pressure (ambulatory blood pressure measurement)
Time Frame: After sessions (24 hours)
|
Post-exercise hypotension, using the Mobil-O-Graph (mmHg).
|
After sessions (24 hours)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Systolic and diastolic blood pressure (resting)
Time Frame: Before and after sessions (15 minutes)
|
Automated oscillometric tensiometer (mmHg)
|
Before and after sessions (15 minutes)
|
|
Central blood pressure
Time Frame: Baseline and post-intervention during sessions (30 minutes)
|
Central systolic and diastolic blood pressure assessed using pulse wave analysis derived from brachial oscillometric measurements.
|
Baseline and post-intervention during sessions (30 minutes)
|
|
Pulse wave velocity
Time Frame: Baseline
|
Arterial stiffness assessed by carotid-femoral pulse wave velocity using applanation tonometry.
This measurement is performed at rest to characterize vascular health.
|
Baseline
|
|
Heart rate
Time Frame: Basline, before and after sessions (15 minutes)
|
Heart rate measured during each experimental session and recovery period using a heart rate monitor to assess cardiovascular response to the intervention.
|
Basline, before and after sessions (15 minutes)
|
|
Cognitive Performance
Time Frame: Baseline
|
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.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 6, 2026
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
September 30, 2027
Study Registration Dates
First Submitted
May 6, 2026
First Submitted That Met QC Criteria
May 21, 2026
First Posted (Actual)
May 26, 2026
Study Record Updates
Last Update Posted (Actual)
May 26, 2026
Last Update Submitted That Met QC Criteria
May 21, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-A00590-49
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pregnancy
-
Far Eastern Memorial HospitalCompletedCornual PregnancyTaiwan
-
Peking Union Medical College HospitalPeking Union Medical CollegeUnknownPregnancy | Pregnancy Related | Infant | Pregnancy Disease | Risk FactorChina
-
Meir Medical CenterRecruiting
-
Bagcilar Training and Research HospitalRecruitingEctopic PregnancyTurkey (Türkiye)
-
MELISA Institute Genomics & Proteomics Research...RecruitingHealthy | Pregnancy | Early Pregnancy | Early Pregnancy Loss | ChildbirthChile
-
Turku University HospitalUniversity of TurkuCompleted
-
Ufuk UniversityNot yet recruitingPregnancy Complications | Pregnancy Loss | Pregnancy Preterm
-
Hadassah Medical OrganizationCompleted
-
Centre Hospitalier Universitaire de Saint EtienneCompletedProlonged PregnancyFrance
-
Zagazig UniversityCompleted
Clinical Trials on Isometric Handgrip Exercise
-
University of Texas at AustinCompleted
-
Instituto de Cardiologia do Rio Grande do SulCompletedHypertension (HTN) | Hypertension ArterialBrazil
-
Mansoura UniversityNot yet recruitingHypertensive Patients
-
University of PernambucoCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Fundação de Amparo... and other collaboratorsCompleted
-
University of PernambucoFundação de Amparo à Pesquisa do Estado de São PauloCompletedPeripheral Artery DiseaseBrazil
-
Riphah International UniversityCompletedHealthy AdolescentsPakistan
-
Instituto de Cardiologia do Rio Grande do SulRecruitingArterial HypertensionBrazil
-
Riphah International UniversityCompletedChronic Obstructive Pulmonary DiseasePakistan
-
KU LeuvenResearch Foundation FlandersCompleted
-
Emory UniversityAmerican Heart AssociationRecruiting