- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07607795
Effect of Isometric Handgrip Exercise on Blood Pressure in Pregnant Women (GRIP4HEALTH)
2026년 5월 21일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
30
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Carina ENEA
- 전화번호: +33 549 454 495
- 이메일: carina.enea@univ-poitiers.fr
연구 연락처 백업
- 이름: Mélanie Gréau Marias
- 전화번호: +33 675 329 599
- 이메일: melanie.greau.marias@univ-poitiers.fr
연구 장소
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Poitiers, 프랑스, 86000
- 모병
- Faculty of Sport Science - MOVE Laboratory - UR 20296
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연락하다:
- Mélanie Gréau Marias
- 전화번호: +33 675 329 599
- 이메일: melanie.greau.marias@univ-poitiers.fr
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
예
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: 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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다른: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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수축기 및 확장기 혈압(외래 혈압 측정)
기간: 세션 후(24시간)
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Mobil-O-Graph(mmHg)를 사용한 운동 후 저혈압.
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세션 후(24시간)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Systolic and diastolic blood pressure (resting)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 3월 6일
기본 완료 (추정된)
2027년 8월 31일
연구 완료 (추정된)
2027년 9월 30일
연구 등록 날짜
최초 제출
2026년 5월 6일
QC 기준을 충족하는 최초 제출
2026년 5월 21일
처음 게시됨 (실제)
2026년 5월 26일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 26일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 21일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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