NCT06618521

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

September 30, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

September 26, 2024

Last Update Submit

December 15, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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).

    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.

    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.

    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.

    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.

    12 weeks

Secondary Outcomes (2)

  • Assessment of level of stress and anxiety

    12 weeks

  • Assessment of serum cortisol level

    12 weeks

Study Arms (3)

Anti-hypertensive drug

ACTIVE COMPARATOR

It consists of 23 pregnant women. They will take Anti-hypertensive drug (Methyldopa 250 mg according to physician instructions).

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.

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.

Drug: Anti-hypertensive drug (Methyldopa 250 mg)Other: Circuit exercise training

Interventions

Each women in the three groups will receive Medical treatment Anti-hypertensive drug (Methyldopa 250 mg) according to physician instructions.

Also known as: Methyldopa 250 mg
Anti-hypertensive drugAnti-hypertensive drug + Circuit exercise trainingAnti-hypertensive drug + Pilates exercise

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.

Anti-hypertensive drug + Pilates exercise

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.

Anti-hypertensive drug + Circuit exercise training

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Cardiac problems
  • Cognitive problems
  • Poorly controlled hypertension
  • Diabetes mellitus
  • Inflammatory stage of arthritis
  • Osteoporosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Interventions

Antihypertensive AgentsMethyldopaExercise Movement TechniquesCircuit-Based Exercise

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesDihydroxyphenylalanineCatecholaminesAminesOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsTyrosinePhysical Therapy ModalitiesTherapeuticsPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Abeer Mohamed Eldeeb, PhD

    Professor, Cairo university

    STUDY CHAIR
  • Doaa A. Osman, PhD

    Assistant Professor, Cairo University

    STUDY DIRECTOR
  • Hossam E. Hussein, PhD

    Professor, Al-Azhar University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 26, 2024

First Posted

October 1, 2024

Study Start

September 30, 2024

Primary Completion

September 30, 2025

Study Completion

October 31, 2025

Last Updated

December 19, 2025

Record last verified: 2025-12

Locations