Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia
Enhancing Cardiometabolic Health in Postnatal Women at High-Risk for Preeclampsia Through Exercise Intervention
Women who develop hypertensive disorders of pregnancy have an increased risk of cardiovascular disease later in life. Whether exercise during the postpartum period improves cardiometabolic health in this population remains unclear.
This pilot randomized controlled trial will recruit 40 women who were identified as being at high risk for preeclampsia during pregnancy and subsequently developed a hypertensive disorder of pregnancy. Participants will be enrolled 6 to 8 weeks after delivery and randomly assigned to a 12-week exercise program or standard postnatal care. The exercise program will consist of three sessions per week combining moderate-intensity aerobic exercise, resistance training, and pelvic floor exercises.
Cardiovascular function, blood pressure, blood markers of cardiometabolic health, physical fitness, and body composition will be assessed before and after the 12-week period. Changes in mood, sleep quality, and health-related quality of life will also be evaluated. The study will provide preliminary evidence on the effects of postpartum exercise in this population and inform the design of a larger trial.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Yao Wang, PhD
- Номер телефона: +85235051289
- Электронная почта: yaowang1@cuhk.edu.hk
Места учебы
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Hong Kong
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Hong Kong, Hong Kong, Гонконг
- Рекрутинг
- Department of Obstetrics & Gynaecology, Prince of Wales Hospital
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Контакт:
- Yao Wang, PhD
- Номер телефона: +85235051289
- Электронная почта: yaowang1@cuhk.edu.hk
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Aged 18 to 45 years.
- Identified as being at high risk for preeclampsia during the most recent pregnancy and developed a hypertensive disorder of pregnancy (HDP).
- Had a singleton pregnancy.
- 6 to 8 weeks postpartum at enrollment.
- Physically able to participate in the exercise training program.
- Willing to participate in the study and provide informed consent.
Exclusion Criteria:
- Had a multiple pregnancy.
- Severe medical complications after delivery or other health conditions that contraindicate physical exercise (e.g., severe cardiovascular disease or musculoskeletal disorders).
- Chronic hypertension or diabetes before pregnancy.
- Current use of medication that could potentially affect cardiac function (e.g., medication for heart failure).
- Received antibiotic treatment within the past month.
- Severe mental health disorders that affect the ability to exercise.
- Unable or unwilling to adhere to and attend the 12-week exercise program.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Postpartum Exercise Program
Participants will complete a 12-week exercise program consisting of three supervised sessions per week. Each session will combine moderate-intensity aerobic exercise, resistance training, and pelvic floor exercises. Exercise intensity will be adjusted to individual fitness levels and monitored using heart rate and ratings of perceived exertion. |
Participants assigned to the exercise group will undertake a 12-week program comprising three supervised 60-minute sessions per week. Each session includes a 5-minute warm-up, 20 minutes of moderate-intensity aerobic exercise on a treadmill or stationary bicycle, 20 minutes of resistance training, 10 minutes of pelvic floor exercises, and a 5-minute cool-down. Exercise intensity will be individualized and progressively adjusted according to heart rate and rating of perceived exertion. |
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Без вмешательства: Standard Postnatal Care
Participants will receive standard postnatal care, including routine health check-ups and general advice on postnatal health. They will not receive a structured exercise program as part of the study. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Systolic Blood Pressure
Временное ограничение: Before and after the 12-week exercise intervention
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Systolic blood pressure will be measured in mmHg. Change from baseline to the end of the 12-week intervention will be assessed. |
Before and after the 12-week exercise intervention
|
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Change in Diastolic Blood Pressure
Временное ограничение: Baseline and 12 weeks
|
Diastolic blood pressure will be measured in mmHg using a validated automated device. Change from baseline to the post-intervention assessment will be assessed. |
Baseline and 12 weeks
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Triglyceride Levels
Временное ограничение: Baseline and 12 weeks
|
Serum triglyceride levels will be determined using standard laboratory techniques. Changes in levels will be assessed. |
Baseline and 12 weeks
|
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Change in Total Cholesterol Levels
Временное ограничение: Baseline and 12 weeks
|
Serum total cholesterol levels will be determined using standard laboratory techniques. Changes in levels will be assessed. |
Baseline and 12 weeks
|
|
Change in High-Density Lipoprotein Cholesterol Levels
Временное ограничение: Baseline and 12 weeks
|
Serum high-density lipoprotein cholesterol levels will be determined using standard laboratory techniques. Changes in levels will be assessed. |
Baseline and 12 weeks
|
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Change in Low-Density Lipoprotein Cholesterol Levels
Временное ограничение: Baseline and 12 weeks
|
Serum low-density lipoprotein cholesterol levels will be determined using standard laboratory techniques. Changes in levels will be assessed. |
Baseline and 12 weeks
|
|
Change in Apolipoprotein A-I Levels
Временное ограничение: Baseline and 12 weeks
|
Apolipoprotein A-I levels will be measured using ELISA. Changes in levels will be assessed. |
Baseline and 12 weeks
|
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Change in Apolipoprotein A-II Levels
Временное ограничение: Baseline and 12 weeks
|
Apolipoprotein A-II levels will be measured using ELISA. Changes in levels will be assessed. |
Baseline and 12 weeks
|
|
Change in Apolipoprotein B Levels
Временное ограничение: Baseline and 12 weeks
|
Apolipoprotein B levels will be measured using ELISA. Changes in levels will be assessed. |
Baseline and 12 weeks
|
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Change in Fasting Glucose Levels
Временное ограничение: Baseline and 12 weeks
|
Fasting glucose levels will be determined using standard laboratory tests. Changes in levels will be assessed. |
Baseline and 12 weeks
|
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Change in Glycated Hemoglobin (HbA1c)
Временное ограничение: Baseline and 12 weeks
|
HbA1c will be determined using standard laboratory tests. Changes in levels will be assessed. |
Baseline and 12 weeks
|
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Change in Fasting Insulin Levels
Временное ограничение: Baseline and 12 weeks
|
Fasting insulin levels will be measured using ELISA. Changes in levels will be assessed. |
Baseline and 12 weeks
|
|
Change in C-Peptide Levels
Временное ограничение: Baseline and 12 weeks
|
C-peptide levels will be measured using ELISA. Changes in levels will be assessed. |
Baseline and 12 weeks
|
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Change in Adiponectin Levels
Временное ограничение: Baseline and 12 weeks
|
Adiponectin levels will be measured using ELISA. Changes in levels will be assessed. |
Baseline and 12 weeks
|
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Change in Leptin Levels
Временное ограничение: Baseline and 12 weeks
|
Leptin levels will be measured using ELISA. Changes in levels will be assessed. |
Baseline and 12 weeks
|
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Change in High-Sensitivity C-Reactive Protein Levels
Временное ограничение: Baseline and 12 weeks
|
High-sensitivity C-reactive protein levels will be measured using ELISA. Changes in levels will be assessed. |
Baseline and 12 weeks
|
|
Change in Tumor Necrosis Factor-Alpha Levels
Временное ограничение: Baseline and 12 weeks
|
Tumor necrosis factor-alpha levels will be measured using ELISA. Changes in levels will be assessed. |
Baseline and 12 weeks
|
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Change in Interleukin-6 Levels
Временное ограничение: Baseline and 12 weeks
|
Interleukin-6 Levels Interleukin-6 levels will be measured using ELISA. Changes in levels will be assessed. |
Baseline and 12 weeks
|
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Change in Fibrinogen Levels
Временное ограничение: Baseline and 12 weeks
|
Blood fibrinogen levels will be measured using a commercial ELISA kit. Changes in levels will be assessed. |
Baseline and 12 weeks
|
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Change in Endothelin-1 Levels
Временное ограничение: Baseline and 12 weeks
|
Endothelin-1 Levels Endothelin-1 levels will be measured using a commercial ELISA kit. Changes in levels will be assessed. |
Baseline and 12 weeks
|
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Change in Angiotensin II Levels
Временное ограничение: Baseline and 12 weeks
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Angiotensin II levels will be measured using a commercial ELISA kit. Changes in levels will be assessed. |
Baseline and 12 weeks
|
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Change in Edinburgh Postnatal Depression Scale Score
Временное ограничение: Baseline and 12 weeks
|
Postpartum depressive symptoms will be assessed using the Edinburgh Postnatal Depression Scale (EPDS). Change in score from before to after the 12-week intervention will be assessed. |
Baseline and 12 weeks
|
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Change in 36-Item Short Form Health Survey Scores
Временное ограничение: Baseline and 12 weeks
|
Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). Changes in questionnaire scores from before to after the 12-week intervention will be assessed. |
Baseline and 12 weeks
|
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Change in Pittsburgh Sleep Quality Index Score
Временное ограничение: Baseline and 12 weeks
|
Pittsburgh Sleep Quality Index Score Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Change in score from before to after the 12-week intervention will be assessed. |
Baseline and 12 weeks
|
|
Change in Breastfeeding Self-Efficacy Scale-Short Form Score
Временное ограничение: Baseline and 12 weeks
|
Breastfeeding self-efficacy will be assessed using the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF). Change in score from before to after the 12-week intervention will be assessed. |
Baseline and 12 weeks
|
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Change in Six-Minute Walk Test Performance
Временное ограничение: Baseline and 12 weeks
|
Physical performance will be assessed using the Six-Minute Walk Test. Change from baseline to the post-intervention assessment will be assessed. |
Baseline and 12 weeks
|
|
Change in Chair Stand Test Performance
Временное ограничение: Baseline and 12 weeks
|
Lower-body physical performance will be assessed using a Chair Stand test. Change from baseline to the post-intervention assessment will be assessed. |
Baseline and 12 weeks
|
|
Change in Body Mass Index
Временное ограничение: Baseline and 12 weeks
|
Body mass index (BMI) will be measured. Change from baseline to the post-intervention assessment will be assessed. |
Baseline and 12 weeks
|
|
Change in Fat Mass Percentage
Временное ограничение: Baseline and 12 weeks
|
Body fat percentage will be assessed at baseline and after the intervention. Changes from baseline to the post-intervention assessment will be evaluated. |
Baseline and 12 weeks
|
|
Change in Lean Mass Percentage
Временное ограничение: Baseline and 12 weeks
|
Lean mass percentage will be assessed at baseline and after the intervention. The change from baseline to the post-intervention assessment will be evaluated. |
Baseline and 12 weeks
|
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Change in Vital Capacity
Временное ограничение: Baseline and 12 weeks
|
Change in vital capacity from baseline to the post-intervention assessment will be assessed. |
Baseline and 12 weeks
|
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Change in Plank Test Performance
Временное ограничение: Baseline and 12 weeks
|
Change in plank test performance from baseline to the post-intervention assessment will be assessed. |
Baseline and 12 weeks
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- CREC Ref. No.: 2024.459
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Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .