ClinicalTrials.gg
RecruitingNCT07921173Updated Nov 6, 2026

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

An interventional study of Postpartum Exercise Program in Postpartum Exercise, Cardiometabolic Health and High Risk for Preeclampsia, sponsored by Chinese University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Sep 2026; still recruiting 2 months later.
Updated Nov 6, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Postpartum Exercise
  • Cardiometabolic Health
  • High Risk for Preeclampsia
  • Randomized Controlled Trial

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03

In context

Pre-Eclampsia

916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.

This study's planned enrollment of 40 is below the median of 110 across 480 interventional studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

Chinese University of Hong Kong is the lead sponsor of 1,454 studies on the registry; 474 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    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.

    Behavioral: Postpartum Exercise Program

  • No intervention
    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.

Interventions

  • BehavioralPostpartum 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.

06

What researchers measure

Primary outcomes

  1. Change in Systolic Blood Pressure

    Systolic blood pressure will be measured in mmHg. Change from baseline to the end of the 12-week intervention will be assessed.

    Time frame: Before and after the 12-week exercise intervention

  2. Change in Diastolic Blood Pressure

    Diastolic blood pressure will be measured in mmHg using a validated automated device. Change from baseline to the post-intervention assessment will be assessed.

    Time frame: Baseline and 12 weeks

Secondary outcomes

  1. Change in Triglyceride Levels

    Serum triglyceride levels will be determined using standard laboratory techniques. Changes in levels will be assessed.

    Time frame: Baseline and 12 weeks

  2. Change in Total Cholesterol Levels

    Serum total cholesterol levels will be determined using standard laboratory techniques. Changes in levels will be assessed.

    Time frame: Baseline and 12 weeks

  3. Change in High-Density Lipoprotein Cholesterol Levels

    Serum high-density lipoprotein cholesterol levels will be determined using standard laboratory techniques. Changes in levels will be assessed.

    Time frame: Baseline and 12 weeks

  4. Change in Low-Density Lipoprotein Cholesterol Levels

    Serum low-density lipoprotein cholesterol levels will be determined using standard laboratory techniques. Changes in levels will be assessed.

    Time frame: Baseline and 12 weeks

  5. Change in Apolipoprotein A-I Levels

    Apolipoprotein A-I levels will be measured using ELISA. Changes in levels will be assessed.

    Time frame: Baseline and 12 weeks

  6. Change in Apolipoprotein A-II Levels

    Apolipoprotein A-II levels will be measured using ELISA. Changes in levels will be assessed.

    Time frame: Baseline and 12 weeks

  7. Change in Apolipoprotein B Levels

    Apolipoprotein B levels will be measured using ELISA. Changes in levels will be assessed.

    Time frame: Baseline and 12 weeks

  8. Change in Fasting Glucose Levels

    Fasting glucose levels will be determined using standard laboratory tests. Changes in levels will be assessed.

    Time frame: Baseline and 12 weeks

  9. Change in Glycated Hemoglobin (HbA1c)

    HbA1c will be determined using standard laboratory tests. Changes in levels will be assessed.

    Time frame: Baseline and 12 weeks

  10. Change in Fasting Insulin Levels

    Fasting insulin levels will be measured using ELISA. Changes in levels will be assessed.

    Time frame: Baseline and 12 weeks

  11. Change in C-Peptide Levels

    C-peptide levels will be measured using ELISA. Changes in levels will be assessed.

    Time frame: Baseline and 12 weeks

  12. Change in Adiponectin Levels

    Adiponectin levels will be measured using ELISA. Changes in levels will be assessed.

    Time frame: Baseline and 12 weeks

  13. Change in Leptin Levels

    Leptin levels will be measured using ELISA. Changes in levels will be assessed.

    Time frame: Baseline and 12 weeks

  14. Change in High-Sensitivity C-Reactive Protein Levels

    High-sensitivity C-reactive protein levels will be measured using ELISA. Changes in levels will be assessed.

    Time frame: Baseline and 12 weeks

  15. Change in Tumor Necrosis Factor-Alpha Levels

    Tumor necrosis factor-alpha levels will be measured using ELISA. Changes in levels will be assessed.

    Time frame: Baseline and 12 weeks

  16. Change in Interleukin-6 Levels

    Interleukin-6 Levels Interleukin-6 levels will be measured using ELISA. Changes in levels will be assessed.

    Time frame: Baseline and 12 weeks

  17. Change in Fibrinogen Levels

    Blood fibrinogen levels will be measured using a commercial ELISA kit. Changes in levels will be assessed.

    Time frame: Baseline and 12 weeks

  18. Change in Endothelin-1 Levels

    Endothelin-1 Levels Endothelin-1 levels will be measured using a commercial ELISA kit. Changes in levels will be assessed.

    Time frame: Baseline and 12 weeks

  19. Change in Angiotensin II Levels

    Angiotensin II levels will be measured using a commercial ELISA kit. Changes in levels will be assessed.

    Time frame: Baseline and 12 weeks

  20. Change in Edinburgh Postnatal Depression Scale Score

    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.

    Time frame: Baseline and 12 weeks

  21. Change in 36-Item Short Form Health Survey Scores

    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.

    Time frame: Baseline and 12 weeks

  22. Change in Pittsburgh Sleep Quality Index Score

    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.

    Time frame: Baseline and 12 weeks

  23. Change in Breastfeeding Self-Efficacy Scale-Short Form Score

    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.

    Time frame: Baseline and 12 weeks

  24. Change in Six-Minute Walk Test Performance

    Physical performance will be assessed using the Six-Minute Walk Test. Change from baseline to the post-intervention assessment will be assessed.

    Time frame: Baseline and 12 weeks

  25. Change in Chair Stand Test Performance

    Lower-body physical performance will be assessed using a Chair Stand test. Change from baseline to the post-intervention assessment will be assessed.

    Time frame: Baseline and 12 weeks

  26. Change in Body Mass Index

    Body mass index (BMI) will be measured. Change from baseline to the post-intervention assessment will be assessed.

    Time frame: Baseline and 12 weeks

  27. Change in Fat Mass Percentage

    Body fat percentage will be assessed at baseline and after the intervention. Changes from baseline to the post-intervention assessment will be evaluated.

    Time frame: Baseline and 12 weeks

  28. Change in Lean Mass Percentage

    Lean mass percentage will be assessed at baseline and after the intervention. The change from baseline to the post-intervention assessment will be evaluated.

    Time frame: Baseline and 12 weeks

  29. Change in Vital Capacity

    Change in vital capacity from baseline to the post-intervention assessment will be assessed.

    Time frame: Baseline and 12 weeks

  30. Change in Plank Test Performance

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

    Time frame: Baseline and 12 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for Sep 2027, 12 months after the start.

Of 171 non-industry interventional studies with no phase under Pre-Eclampsia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's planned 12 months is below that.

Counting every sponsor, half of 176 studies reached it within 24 months; a quarter within 9 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 2, 2026
First posted
Nov 6, 2026
StartActual
Sep 3, 2026
Primary completionEst.
Sep 30, 2027
CompletionEst.
Dec 31, 2027
Last update
Nov 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07921173
Responsible party
LAI KWAN LAM (Postdoctoral Fellow, Chinese University of Hong Kong) — Principal investigator
First posted
Nov 6, 2026
Start date
Sep 3, 2026
Primary completion
Sep 30, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Nov 6, 2026

Study contacts

Yao Wang, PhD
Contact
yaowang1@cuhk.edu.hk
+85235051289

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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