- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06618521
Effect of Pilates Exercise Versus Circuit Exercise Training on Gestational Hypertension
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Giza, Egypt
- Cairo University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Cardiac problems
- Cognitive problems
- Poorly controlled hypertension
- Diabetes mellitus
- Inflammatory stage of arthritis
- Osteoporosis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Anti-hypertensive drug
It consists of 23 pregnant women.
They will take Anti-hypertensive drug (Methyldopa 250 mg according to physician instructions).
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Each women in the three groups will receive Medical treatment Anti-hypertensive drug (Methyldopa 250 mg) according to physician instructions.
Other Names:
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Experimental: Anti-hypertensive drug + Pilates exercise
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.
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Each women in the three groups will receive Medical treatment Anti-hypertensive drug (Methyldopa 250 mg) according to physician instructions.
Other Names:
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.
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Experimental: Anti-hypertensive drug + Circuit exercise training
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.
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Each women in the three groups will receive Medical treatment Anti-hypertensive drug (Methyldopa 250 mg) according to physician instructions.
Other Names:
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Assessment of serum triglycerides level
Time Frame: 12 weeks
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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.
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12 weeks
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Assessment of serum total cholesterol level
Time Frame: 12 weeks
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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.
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12 weeks
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Assessment of serum low-density lipoprotein (LDL) level
Time Frame: 12 weeks
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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.
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12 weeks
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Assessment of serum high-density lipoprotein (HDL) level
Time Frame: 12 weeks
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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.
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12 weeks
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Measurement of mean arterial blood pressure
Time Frame: 12 weeks
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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).
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Assessment of level of stress and anxiety
Time Frame: 12 weeks
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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.
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12 weeks
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Assessment of serum cortisol level
Time Frame: 12 weeks
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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.
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12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Abeer Mohamed Eldeeb, PhD, Professor, Cairo university
- Study Director: Doaa A. Osman, PhD, Assistant Professor, Cairo university
- Study Director: Hossam E. Hussein, PhD, Professor, Al-Azhar University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Pregnancy Complications
- Hypertension
- Hypertension, Pregnancy-Induced
- Amino Acids, Peptides, and Proteins
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Organic Chemicals
- Therapeutics
- Pharmacologic Actions
- Chemical Actions and Uses
- Therapeutic Uses
- Hydrocarbons
- Hydrocarbons, Cyclic
- Physical Therapy Modalities
- Hydrocarbons, Aromatic
- Amines
- Amino Acids
- Catechols
- Phenols
- Benzene Derivatives
- Physical Conditioning, Human
- Phenylalanine
- Amino Acids, Aromatic
- Amino Acids, Cyclic
- Exercise
- Catecholamines
- Dihydroxyphenylalanine
- Cardiovascular Agents
- Tyrosine
- Antihypertensive Agents
- Methyldopa
- Exercise Movement Techniques
- Circuit-Based Exercise
Other Study ID Numbers
- P.T.REC/012/004254
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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