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Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia

2. listopadu 2026 aktualizováno: LAI KWAN LAM, Chinese University of Hong Kong

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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

40

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Hongkong
    • Hong Kong
      • Hong Kong, Hong Kong, Hongkong
        • Nábor
        • Department of Obstetrics & Gynaecology, Prince of Wales Hospital
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 45 let (Dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Ženský

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Behaviorální: Postpartum Exercise Program

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.
Žádný zásah: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Systolic Blood Pressure
Časové okno: Before and after the 12-week exercise intervention

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
Change in Diastolic Blood Pressure
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Triglyceride Levels
Časové okno: Baseline and 12 weeks

Serum triglyceride levels will be determined using standard laboratory techniques. Changes in levels will be assessed.
Baseline and 12 weeks
Change in Total Cholesterol Levels
Časové okno: 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
Časové okno: 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
Change in Low-Density Lipoprotein Cholesterol Levels
Časové okno: 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
Časové okno: Baseline and 12 weeks

Apolipoprotein A-I levels will be measured using ELISA. Changes in levels will be assessed.
Baseline and 12 weeks
Change in Apolipoprotein A-II Levels
Časové okno: 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
Časové okno: Baseline and 12 weeks

Apolipoprotein B levels will be measured using ELISA. Changes in levels will be assessed.
Baseline and 12 weeks
Change in Fasting Glucose Levels
Časové okno: Baseline and 12 weeks

Fasting glucose levels will be determined using standard laboratory tests. Changes in levels will be assessed.
Baseline and 12 weeks
Change in Glycated Hemoglobin (HbA1c)
Časové okno: Baseline and 12 weeks

HbA1c will be determined using standard laboratory tests. Changes in levels will be assessed.
Baseline and 12 weeks
Change in Fasting Insulin Levels
Časové okno: 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
Časové okno: Baseline and 12 weeks

C-peptide levels will be measured using ELISA. Changes in levels will be assessed.
Baseline and 12 weeks
Change in Adiponectin Levels
Časové okno: Baseline and 12 weeks

Adiponectin levels will be measured using ELISA. Changes in levels will be assessed.
Baseline and 12 weeks
Change in Leptin Levels
Časové okno: Baseline and 12 weeks

Leptin levels will be measured using ELISA. Changes in levels will be assessed.
Baseline and 12 weeks
Change in High-Sensitivity C-Reactive Protein Levels
Časové okno: 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
Časové okno: Baseline and 12 weeks

Tumor necrosis factor-alpha levels will be measured using ELISA. Changes in levels will be assessed.
Baseline and 12 weeks
Change in Interleukin-6 Levels
Časové okno: 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
Change in Fibrinogen Levels
Časové okno: 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
Change in Endothelin-1 Levels
Časové okno: 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
Change in Angiotensin II Levels
Časové okno: Baseline and 12 weeks

Angiotensin II levels will be measured using a commercial ELISA kit. Changes in levels will be assessed.
Baseline and 12 weeks
Change in Edinburgh Postnatal Depression Scale Score
Časové okno: 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
Change in 36-Item Short Form Health Survey Scores
Časové okno: 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
Change in Pittsburgh Sleep Quality Index Score
Časové okno: 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
Časové okno: 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
Change in Six-Minute Walk Test Performance
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Change in Vital Capacity
Časové okno: Baseline and 12 weeks

Change in vital capacity from baseline to the post-intervention assessment will be assessed.
Baseline and 12 weeks
Change in Plank Test Performance
Časové okno: Baseline and 12 weeks

Change in plank test performance from baseline to the post-intervention assessment will be assessed.
Baseline and 12 weeks

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Chinese University of Hong Kong

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

3. září 2026

Primární dokončení (Odhadovaný)

30. září 2027

Dokončení studie (Odhadovaný)

31. prosince 2027

Termíny zápisu do studia

První předloženo

2. listopadu 2026

První předloženo, které splnilo kritéria kontroly kvality

2. listopadu 2026

První zveřejněno (Aktuální)

6. listopadu 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

6. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

2. listopadu 2026

Naposledy ověřeno

1. října 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • CREC Ref. No.: 2024.459

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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