NCT07607795

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable pregnancy

Timeline
16mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress18%
Mar 2026Sep 2027

Study Start

First participant enrolled

March 6, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 26, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

May 26, 2026

Status Verified

May 1, 2026

Enrollment Period

1.5 years

First QC Date

May 6, 2026

Last Update Submit

May 21, 2026

Conditions

Keywords

Isometric ExerciseHandgrip ExerciseBlood PressureAmbulatory Blood Pressure MonitoringPregnancyHypertensionArterial StiffnessCognitive Function

Outcome Measures

Primary Outcomes (1)

  • Systolic and diastolic blood pressure (ambulatory blood pressure measurement)

    Post-exercise hypotension, using the Mobil-O-Graph (mmHg).

    After sessions (24 hours)

Secondary Outcomes (5)

  • Systolic and diastolic blood pressure (resting)

    Before and after sessions (15 minutes)

  • Central blood pressure

    Baseline and post-intervention during sessions (30 minutes)

  • Pulse wave velocity

    Baseline

  • Heart rate

    Basline, before and after sessions (15 minutes)

  • Cognitive Performance

    Baseline

Study Arms (2)

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.

Behavioral: Isometric Handgrip ExerciseBehavioral: 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.

Behavioral: Isometric Handgrip ExerciseBehavioral: Control Rest

Interventions

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.

Hypertensive Pregnant WomenNormotensive Pregnant Women
Control RestBEHAVIORAL

Seated rest condition without exercise, used as a control comparison to the isometric handgrip intervention.

Hypertensive Pregnant WomenNormotensive Pregnant Women

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Sport Science - MOVE Laboratory - UR 20296

Poitiers, 86000, France

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: This is a randomized crossover study. Each participant completes two experimental conditions (isometric handgrip exercise and control rest) in a random order.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

May 6, 2026

First Posted

May 26, 2026

Study Start

March 6, 2026

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

May 26, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations