Gestational HypertensionNCT06618521
Effect of Pilates Exercise Versus Circuit Exercise Training on Gestational Hypertension
A study testing Anti-hypertensive drug (Methyldopa 250 mg), Pilates exercise and Circuit exercise training in people with Gestational Hypertension, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of the study is to investigate the effect of Pilates exercises versus circuit exercise training on blood pressure and lipids in gestational hypertensive women. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Gestational Hypertension
- What is being tested?
- Anti-hypertensive drug (Methyldopa 250 mg), Pilates exercise and Circuit exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Sep 2024to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- They will be diagnosed by obstetrician after 20 weeks' gestation as having blood pressure higher than 140/90 without any organ damage.
- Age will range from 25-35 years old .
- Body mass index (BMI) will range from 30-34.9 Kg/m².
Who cannot join
- Cardiac problems
- Cognitive problems
- Poorly controlled hypertension
- Diabetes mellitus
- Inflammatory stage of arthritis
- Osteoporosis
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to investigate the effect of Pilates exercises versus circuit exercise training on blood pressure and lipids in gestational hypertensive women.
Read the detailed description
Gestational hypertension is one of the most common disorders seen in human pregnancies. The disorder progresses into pre-eclampsia, a dangerous condition that can prove fatal to expectant mothers. If it is untreated several complications result such as eclampsia, stroke, the need for labor induction and placental abruption, preterm delivery, and low birth weight.
Most pregnant women use medication during pregnancy despite increasing availability of information about teratogenic risks. Medication use during pregnancy still causes uncertainty and concern among pregnant women and their health care providers. Medication use has a harmful effect on the fetus such as congenital anomalies, preterm birth, low birth weight, growth retardation of the fetus, and developmental delays in totality. It remains unknown what the major concerns are among pregnant women regarding medication use.
Health organizations recommend lifestyle changes that include increased levels of physical activity. Also, some researchers have recommended aerobic training for 30 minutes per day that is supplemented with resistance exercise.
Pilates exercises have been showed to be safe modality for pregnant women. It showed many benefits on childbirth. It also yields a significant decrease in clinical systolic and diastolic and mean blood pressure at rest and over 24 hours, in hypertensive non-pregnant women. Pilates may be recommended as a non-drug intervention for the prevention, treatment, and control hypertension. Circuit exercise training is also a non-drug intervention may reduce systemic arterial hypertension to lower cardiovascular risk.
Due to the progressive increase in maternal estrogen with pregnancy, maternal fat deposits switch from anabolic to catabolic states to maintain appropriate development of the fetus and placenta. This switch to catabolism increases the breakdown of fat stores, which increases total cholesterol and triglyceride available for maternal and fetal utilization. Further, it is essential for a normalized maternal lipid profile to ensure healthy fetal development and pregnancy outcomes.
Therefore, this study will be conducted to provide evidence based for the effectiveness of Pilates exercise and circuit training on blood pressure and lipid profile in gestational hypertensive women for healthcare providers interested in women's health.
- Conditions
- Gestational Hypertension
- Being tested
- Anti-hypertensive drug (Methyldopa 250 mg), Pilates exercise, Circuit exercise training
- Medical subject headings
- Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-hypertensive drug (Methyldopa 250 mg)Drug
Also called Methyldopa 250 mg
Each women in the three groups will receive Medical treatment Anti-hypertensive drug (Methyldopa 250 mg) according to physician instructions.
Pilates exerciseOther
Each women in the second group will receive Mat Pilates training exercise for 40 minutes/ day, 3 days/week, for 12 weeks beginning 20 weeks' gestation. The Pilates exercise includes pelvic floor exercise, deep tummy strengthening, pelvic tilt, upper back stretch, the cat stretch, thigh stretch, the sword, sword arm, and wagging the tail.
Circuit exercise trainingOther
Each women in group C will receive circuit training exercises in form of single leg curl up and press, sumo squat and row to reverse fly stand for 40 minutes/ day, 3 days/ week, for 12 weeks beginning 20 weeks' gestation. The Circuit exercise training includes sumo squat, quadruped extension, row to reverse fly stand, and single leg curls up.
| Study group | Role | What they receive |
|---|---|---|
| Anti-hypertensive drug | Active comparator | It consists of 23 pregnant women. They will take Anti-hypertensive drug (Methyldopa 250 mg according to physician instructions). Receives: Drug: Anti-hypertensive drug (Methyldopa 250 mg) |
| Anti-hypertensive drug + Pilates exercise | Experimental | It consists of 23 pregnant women. They will be engaged in Pilates exercise for 40 minutes/day, 3 days/week, for 12 weeks, in addition to Anti-hypertensive drug (Methyldopa 250 mg according to physician instructions. Receives: Drug: Anti-hypertensive drug (Methyldopa 250 mg); Other: Pilates exercise |
| Anti-hypertensive drug + Circuit exercise training | Experimental | It consists of 23 pregnant women. They will be engaged in a supervised circuit training exercises for 40 minutes/ day, 3 days/week, for 12 weeks, in addition to Anti-hypertensive drug (Methyldopa 250 mg according to physician instructions. Receives: Drug: Anti-hypertensive drug (Methyldopa 250 mg); Other: Circuit exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of mean arterial blood pressure
Pregnant women will be seated in a relaxed position with the arm supported on a table. A cuff will be secured around the bicep without excessive tightness. The cuff will be inflated while observing the aneroid monitor until the pressure reaches 20-30 mmHg above the usual blood pressure. A stethoscope will be placed below the cuff at the elbow crease, and the cuff will be gradually deflated. Systolic pressure will be recorded at the first Korotkoff sound, and diastolic pressure will be recorded when the sounds disappear. Mean arterial blood pressure will be measured for each pregnant woman in the three groups before and after the treatment procedures using the equation: MAP = 1/3 (SBP) + 2/3 (DBP).
Measured: 12 weeks
Assessment of serum triglycerides level
It will be assessed for each pregnant women in the three groups before and after the end of the treatment procedures.The blood samples will be collected after fasting for 9-12 hours. Participants will be asked to lie in half lying position with well supported back and arm, the antecubital area will be cleaned with alcohol. Blood sample of about 5cm will be drawn in the morning (at 8 clock) range between 7and 25 micrograms per deciliter (mcg-dl). Blood sample will be using disposable syringe and collected in sterilized tube.
Measured: 12 weeks
Assessment of serum total cholesterol level
It will be assessed for each pregnant women in the three groups before and after the end of the treatment procedures.The blood samples will be collected after fasting for 9-12 hours. Participants will be asked to lie in half lying position with well supported back and arm, the antecubital area will be cleaned with alcohol. Blood sample of about 5cm will be drawn in the morning (at 8 clock) range between 7and 25 micrograms per deciliter (mcg-dl). Blood sample will be using disposable syringe and collected in sterilized tube.
Measured: 12 weeks
Assessment of serum low-density lipoprotein (LDL) level
It will be assessed for each pregnant women in the three groups before and after the end of the treatment procedures.The blood samples will be collected after fasting for 9-12 hours. Participants will be asked to lie in half lying position with well supported back and arm, the antecubital area will be cleaned with alcohol. Blood sample of about 5cm will be drawn in the morning (at 8 clock) range between 7and 25 micrograms per deciliter (mcg-dl). Blood sample will be using disposable syringe and collected in sterilized tube.
Measured: 12 weeks
Assessment of serum high-density lipoprotein (HDL) level
It will be assessed for each pregnant women in the three groups before and after the end of the treatment procedures.The blood samples will be collected after fasting for 9-12 hours. Participants will be asked to lie in half lying position with well supported back and arm, the antecubital area will be cleaned with alcohol. Blood sample of about 5cm will be drawn in the morning (at 8 clock) range between 7and 25 micrograms per deciliter (mcg-dl). Blood sample will be using disposable syringe and collected in sterilized tube.
Measured: 12 weeks
Secondary outcomes (2)
Assessment of level of stress and anxiety
Visual analogue scale (VAS) will be used to assess the level of stress and anxiety for each pregnant woman in the three groups. VAS is a straight line; its ends are defined as the extreme limits of stress, with 0 indicates no stress and anxiety, while 10 indicates maximum stress and anxiety. The pregnant woman will select and marks on the line the suitable description of her stress level before and after the end of the treatment course.
Measured: 12 weeks
Assessment of serum cortisol level
It will be assessed for each pregnant women in the three groups before and after the end of the treatment procedures.The blood samples will be collected after fasting for 9-12 hours. Participants will be asked to lie in half lying position with well supported back and arm, the antecubital area will be cleaned with alcohol. Blood sample of about 5cm will be drawn in the morning (at 8 clock) range between 7and 25 micrograms per deciliter (mcg-dl). Blood sample will be using disposable syringe and collected in sterilized tube.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start30 Sep 2024
- Primary completion30 Sep 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational HypertensionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Hamed Ibrahim ElMorsy, Cairo University
- Investigators
- Abeer Mohamed Eldeeb, PhD, Study chair, Professor, Cairo universityDoaa A. Osman, PhD, Study director, Assistant Professor, Cairo UniversityHossam E. Hussein, PhD, Study director, Professor, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618521
- Sponsor's protocol ID
- P.T.REC/012/004254
- Status last verified
- Dec 2025
- First submitted
- 26 Sep 2024
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pilates Exercise Versus Circuit Exercise Training on Gestational Hypertension
- ClinicalTrials.gov ID
- NCT06618521
- Acronym / sponsor ID
- P.T.REC/012/004254
- Conditions
- Gestational Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to investigate the effect of Pilates exercises versus circuit exercise training on blood pressure and lipids in gestational hypertensive women.
Detailed description
Gestational hypertension is one of the most common disorders seen in human pregnancies. The disorder progresses into pre-eclampsia, a dangerous condition that can prove fatal to expectant mothers. If it is untreated several complications result such as eclampsia, stroke, the need for labor induction and placental abruption, preterm delivery, and low birth weight.
Most pregnant women use medication during pregnancy despite increasing availability of information about teratogenic risks. Medication use during pregnancy still causes uncertainty and concern among pregnant women and their health care providers. Medication use has a harmful effect on the fetus such as congenital anomalies, preterm birth, low birth weight, growth retardation of the fetus, and developmental delays in totality. It remains unknown what the major concerns are among pregnant women regarding medication use.
Health organizations recommend lifestyle changes that include increased levels of physical activity. Also, some researchers have recommended aerobic training for 30 minutes per day that is supplemented with resistance exercise.
Pilates exercises have been showed to be safe modality for pregnant women. It showed many benefits on childbirth. It also yields a significant decrease in clinical systolic and diastolic and mean blood pressure at rest and over 24 hours, in hypertensive non-pregnant women. Pilates may be recommended as a non-drug intervention for the prevention, treatment, and control hypertension. Circuit exercise training is also a non-drug intervention may reduce systemic arterial hypertension to lower cardiovascular risk.
Due to the progressive increase in maternal estrogen with pregnancy, maternal fat deposits switch from anabolic to catabolic states to maintain appropriate development of the fetus and placenta. This switch to catabolism increases the breakdown of fat stores, which increases total cholesterol and triglyceride available for maternal and fetal utilization. Further, it is essential for a normalized maternal lipid profile to ensure healthy fetal development and pregnancy outcomes.
Therefore, this study will be conducted to provide evidence based for the effectiveness of Pilates exercise and circuit training on blood pressure and lipid profile in gestational hypertensive women for healthcare providers interested in women's health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anti-hypertensive drug | Active comparator | Drug: Anti-hypertensive drug (Methyldopa 250 mg)It consists of 23 pregnant women. They will take Anti-hypertensive drug (Methyldopa 250 mg according to physician instructions). |
| Anti-hypertensive drug + Pilates exercise | Experimental | Drug: Anti-hypertensive drug (Methyldopa 250 mg), Other: Pilates exerciseIt consists of 23 pregnant women. They will be engaged in Pilates exercise for 40 minutes/day, 3 days/week, for 12 weeks, in addition to Anti-hypertensive drug (Methyldopa 250 mg according to physician instructions. |
| Anti-hypertensive drug + Circuit exercise training | Experimental | Drug: Anti-hypertensive drug (Methyldopa 250 mg), Other: Circuit exercise trainingIt consists of 23 pregnant women. They will be engaged in a supervised circuit training exercises for 40 minutes/ day, 3 days/week, for 12 weeks, in addition to Anti-hypertensive drug (Methyldopa 250 mg according to physician instructions. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- They will be diagnosed by obstetrician after 20 weeks' gestation as having blood pressure higher than 140/90 without any organ damage.
- Age will range from 25-35 years old .
- Body mass index (BMI) will range from 30-34.9 Kg/m².
Key exclusion criteria (6 listed)
- Cardiac problems
- Cognitive problems
- Poorly controlled hypertension
- Diabetes mellitus
- Inflammatory stage of arthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-hypertensive drug (Methyldopa 250 mg)Also: Methyldopa 250 mgEach women in the three groups will receive Medical treatment Anti-hypertensive drug (Methyldopa 250 mg) according to physician instructions. | Drug | Anti-hypertensive drug, Anti-hypertensive drug + Circuit exercise training, Anti-hypertensive drug + Pilates exercise |
| Pilates exerciseEach women in the second group will receive Mat Pilates training exercise for 40 minutes/ day, 3 days/week, for 12 weeks beginning 20 weeks' gestation. The Pilates exercise includes pelvic floor exercise, deep tummy strengthening, pelvic tilt, upper back stretch, the cat stretch, thigh stretch, the sword, sword arm, and wagging the tail. | Other | Anti-hypertensive drug + Pilates exercise |
| Circuit exercise trainingEach women in group C will receive circuit training exercises in form of single leg curl up and press, sumo squat and row to reverse fly stand for 40 minutes/ day, 3 days/ week, for 12 weeks beginning 20 weeks' gestation. The Circuit exercise training includes sumo squat, quadruped extension, row to reverse fly stand, and single leg curls up. | Other | Anti-hypertensive drug + Circuit exercise training |
Primary outcome
Measurement of mean arterial blood pressure
Time frame: 12 weeks
Pregnant women will be seated in a relaxed position with the arm supported on a table. A cuff will be secured around the bicep without excessive tightness. The cuff will be inflated while observing the aneroid monitor until the pressure reaches 20-30 mmHg above the usual blood pressure. A stethoscope will be placed below the cuff at the elbow crease, and the cuff will be gradually deflated. Systolic pressure will be recorded at the first Korotkoff sound, and diastolic pressure will be recorded when the sounds disappear. Mean arterial blood pressure will be measured for each pregnant woman in the three groups before and after the treatment procedures using the equation: MAP = 1/3 (SBP) + 2/3 (DBP).
Assessment of serum triglycerides level
Time frame: 12 weeks
It will be assessed for each pregnant women in the three groups before and after the end of the treatment procedures.The blood samples will be collected after fasting for 9-12 hours. Participants will be asked to lie in half lying position with well supported back and arm, the antecubital area will be cleaned with alcohol. Blood sample of about 5cm will be drawn in the morning (at 8 clock) range between 7and 25 micrograms per deciliter (mcg-dl). Blood sample will be using disposable syringe and collected in sterilized tube.
Assessment of serum total cholesterol level
Time frame: 12 weeks
It will be assessed for each pregnant women in the three groups before and after the end of the treatment procedures.The blood samples will be collected after fasting for 9-12 hours. Participants will be asked to lie in half lying position with well supported back and arm, the antecubital area will be cleaned with alcohol. Blood sample of about 5cm will be drawn in the morning (at 8 clock) range between 7and 25 micrograms per deciliter (mcg-dl). Blood sample will be using disposable syringe and collected in sterilized tube.
Assessment of serum low-density lipoprotein (LDL) level
Time frame: 12 weeks
It will be assessed for each pregnant women in the three groups before and after the end of the treatment procedures.The blood samples will be collected after fasting for 9-12 hours. Participants will be asked to lie in half lying position with well supported back and arm, the antecubital area will be cleaned with alcohol. Blood sample of about 5cm will be drawn in the morning (at 8 clock) range between 7and 25 micrograms per deciliter (mcg-dl). Blood sample will be using disposable syringe and collected in sterilized tube.
Assessment of serum high-density lipoprotein (HDL) level
Time frame: 12 weeks
It will be assessed for each pregnant women in the three groups before and after the end of the treatment procedures.The blood samples will be collected after fasting for 9-12 hours. Participants will be asked to lie in half lying position with well supported back and arm, the antecubital area will be cleaned with alcohol. Blood sample of about 5cm will be drawn in the morning (at 8 clock) range between 7and 25 micrograms per deciliter (mcg-dl). Blood sample will be using disposable syringe and collected in sterilized tube.
2 secondary outcomes
Assessment of level of stress and anxiety
Time frame: 12 weeks
Assessment of serum cortisol level
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abeer Mohamed Eldeeb, PhD study chair
Professor, Cairo university
Doaa A. Osman, PhD study director
Assistant Professor, Cairo University
Hossam E. Hussein, PhD study director
Professor, Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-hypertensive drug (Methyldopa 250 mg), Pilates exercise and Circuit exercise training in people with Gestational Hypertension, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of mean arterial blood pressure (time frame: 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.