PregnancyGRIP4HEALTHNCT07607795
Effect of Isometric Handgrip Exercise on Blood Pressure in Pregnant Women
A study testing Isometric Handgrip Exercise in people with Pregnancy and Pregnancy - Prenatal Testing, run by University of Poitiers at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Pregnancy - Prenatal Testing, Hypertension (HTN)
- What is being tested?
- Isometric Handgrip Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 6 Mar 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Faculty of Sport Science - MOVE Laboratory - UR 20296
Poitiers, 86000
Mélanie Gréau Marias, +33 675 329 599, melanie.greau.marias@univ-poitiers.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnancy, Pregnancy - Prenatal Testing, Hypertension (HTN)
- Being tested
- Isometric Handgrip Exercise, Control Rest
- Keywords
- Isometric Exercise, Handgrip Exercise, Blood Pressure, Ambulatory Blood Pressure Monitoring, Pregnancy, Hypertension, Arterial Stiffness, Cognitive Function
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric Handgrip ExerciseBehavioural
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.
Control RestBehavioural
Seated rest condition without exercise, used as a control comparison to the isometric handgrip intervention.
| Study group | Role | What they receive |
|---|---|---|
| Normotensive Pregnant Women | Other | Pregnant women without chronic hypertension. Participants in this arm complete both the isometric handgrip exercise session and the control rest session in randomized order. Receives: Behavioral: Isometric Handgrip Exercise; Behavioral: Control Rest |
| Hypertensive Pregnant Women | Other | 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. Receives: Behavioral: Isometric Handgrip Exercise; Behavioral: Control Rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic and diastolic blood pressure (ambulatory blood pressure measurement)
Post-exercise hypotension, using the Mobil-O-Graph (mmHg).
Measured: After sessions (24 hours)
Secondary outcomes (5)
Systolic and diastolic blood pressure (resting)
Automated oscillometric tensiometer (mmHg)
Measured: Before and after sessions (15 minutes)
Central blood pressure
Central systolic and diastolic blood pressure assessed using pulse wave analysis derived from brachial oscillometric measurements.
Measured: Baseline and post-intervention during sessions (30 minutes)
Pulse wave velocity
Arterial stiffness assessed by carotid-femoral pulse wave velocity using applanation tonometry. This measurement is performed at rest to characterize vascular health.
Measured: Baseline
Heart rate
Heart rate measured during each experimental session and recovery period using a heart rate monitor to assess cardiovascular response to the intervention.
Measured: Basline, before and after sessions (15 minutes)
Cognitive Performance
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.
- Stroop : higher scores indicate better executive function and inhibitory control. No universal minimum or maximum score.
- Verbal Fluency Test: higher scores indicate better verbal executive functioning. No universal maximum score.
- Rey Auditory Verbal Learning Test (RAVLT): Higher scores indicate better verbal learning and memory. Minimum score = 0; maximum score = 75.
- Digit Span Test (forward and backward): higher scores indicate better working memory and attention. Minimum score = 0; No universal maximum score.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start6 Mar 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a randomized crossover study. Each participant completes two experimental conditions (isometric handgrip exercise and control rest) in a random order.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Poitiers
- Sponsor type
- University, hospital or other
- Collaborators
- Poitiers University Hospital, Laboratory MOVE, Faculty of Sport Sciences, University of Poitiers, France
- Responsible party
- Principal investigator, Carina Enea, University of Poitiers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607795
- Sponsor's protocol ID
- 2025-A00590-49
- Acronym
- GRIP4HEALTH
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Isometric Handgrip Exercise on Cardiovascular and Cognitive Responses in Normotensive and Hypertensive Pregnant Women (GRIP4HEALTH)
- ClinicalTrials.gov ID
- NCT07607795
- Acronym / sponsor ID
- GRIP4HEALTH / 2025-A00590-49
- Conditions
- Pregnancy, Pregnancy - Prenatal Testing, Hypertension (HTN)
- Keywords
- Isometric Exercise, Handgrip Exercise, Blood Pressure, Ambulatory Blood Pressure Monitoring, Pregnancy, Hypertension, Arterial Stiffness, Cognitive Function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of PoitiersUniversity, hospital or other
- Collaborators
- Poitiers University Hospital, Laboratory MOVE, Faculty of Sport Sciences, University of Poitiers, France
- Study start
- 6 Mar 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized crossover study. Each participant completes two experimental conditions (isometric handgrip exercise and control rest) in a random order.
| Arm | Type | Receives |
|---|---|---|
| Normotensive Pregnant Women | Other | Behavioral: Isometric Handgrip Exercise, Behavioral: Control RestPregnant women without chronic hypertension. Participants in this arm complete both the isometric handgrip exercise session and the control rest session in randomized order. |
| Hypertensive Pregnant Women | Other | Behavioral: Isometric Handgrip Exercise, Behavioral: Control RestPregnant women with chronic untreated hypertension. Participants in this arm complete both the isometric handgrip exercise session and the control rest session in randomized order. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isometric Handgrip ExerciseIsometric 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. | Behavioural | Hypertensive Pregnant Women, Normotensive Pregnant Women |
| Control RestSeated rest condition without exercise, used as a control comparison to the isometric handgrip intervention. | Behavioural | Hypertensive Pregnant Women, Normotensive Pregnant Women |
Primary outcome
Systolic and diastolic blood pressure (ambulatory blood pressure measurement)
Time frame: After sessions (24 hours)
Post-exercise hypotension, using the Mobil-O-Graph (mmHg).
5 secondary outcomes
Systolic and diastolic blood pressure (resting)
Time frame: Before and after sessions (15 minutes)
Central blood pressure
Time frame: Baseline and post-intervention during sessions (30 minutes)
Pulse wave velocity
Time frame: Baseline
Heart rate
Time frame: Basline, before and after sessions (15 minutes)
Cognitive Performance
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isometric Handgrip Exercise in people with Pregnancy and Pregnancy - Prenatal Testing, run by University of Poitiers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carina ENEA (+33 549 454 495, carina.enea@univ-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic and diastolic blood pressure (ambulatory blood pressure measurement) (time frame: After sessions (24 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.