Effect of Circuit Training on Calcium Level and Physical Fittness in Pregnant Women

This study will be conducted to determine the effect of circuit weight training on calcium level and physical fitness in pregnant

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy Related
• Intervention / Treatment: Other: Circuit training

Detailed Description

During pregnancy, hem-dilution causes the serum albumin and hemoglobin to decrease. This fall in albumin causes the total serum calcium to fall to levels normally associated with symptomatic hypocalcaemia. The deficiency also occurs due to low dietary intake of calcium .This deficiency has a negative effect on both the mother and the fetus, as high blood pressure , maternal hypocalcemia, abortion, numbness and tingling in the fingers, muscle and leg cramps, poor appetite, heart problems, premature birth, low birth weight, perinatal death, and neonatal tetany .

General physical exercises specially circuit weight training will aids to increase calcium level as it plays a major role in increasing bone density not only through mechanical loading ,but also through blood PH and biomechanical changes in free ionized calcium, which can positively affect bone density . Circuit weight training exercises can improve the health related physical fitness variables namely cardiovascular fitness , muscular strength, muscular endurance, flexibility , balance and speed

Various studies investigated the effect of circuit weight training on bone mineral density and its effect on improving general fitness but there is a gap in the literature of review about its effect on calcium level and physical fitness in gravid women .So, this study will be of valuable benefits for medical service organizations and increase body of knowledge for physical therapists in women's health field.

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Manal Ahmed Elshafei, lecturer; Phone Number: +20 122 066 4518; Email: manalpt1989@gmail.com
• Study Contact Backup: Name: Manal Ahmed Elshafei; Phone Number: +20 122 066 4518; Email: manalpt1989@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• pregnant women suffering from a decrease in blood calcium level, (<500 mg) dietary intake as recorded by food frequency questionnaire.
• They will be selected at second trimester (18th-24thweeks).
• Their age will range from (20 to 35) years old.
• Their BMI will be (35.00 to39.99) Kg/m2 in the second trimester.

Exclusion Criteria:

• Highly risk pregnant women (gestational diabetes &pre-eclampsia).
• Pregnant women with risk for pre-term labor.
• Pregnant women with a history of habitual abortion.
• Pregnant women with thyroid, kidney and liver dysfunction and women with cardiovascular diseases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Circuit training exercise plus calcium tablets group; Study Group: they will receive circuit training exercise, 3 sessions per week for 12 weeks, in addition to calcium supplements.	Other: Circuit training; Mode : any rhythmical and aerobic activity using large muscle groups that can be maintained continuously.; Intensity: 60% to 90% of maximum heart rate reserve or 50% to 85% of vO2 max.; Duration: 25 to 30 minutes of continuous aerobic activity.; Frequency: three to five days per week.
Other: Calcium tablets group; Control Group: they will receive daily dosage of calcium supplements 1-3 g/ day	Other: Circuit training; Mode : any rhythmical and aerobic activity using large muscle groups that can be maintained continuously.; Intensity: 60% to 90% of maximum heart rate reserve or 50% to 85% of vO2 max.; Duration: 25 to 30 minutes of continuous aerobic activity.; Frequency: three to five days per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calcium levels	Total calcium; Ionized calcium; Free calcium will be measured before and after the study program for pregnant women in both groups.	Up to 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sit and reach flexibility test	The pregnant woman will perform a short warm up before performing a fitness testing. This test measures the flexibility of the lower back and hamstring muscles. The equipment required will a special testing box and ruler. The procedure of this test involves sitting on the floor with legs stretched out straight ahead. After some practice reaches, the participating woman reaches out and holds that position for one-two seconds while the distance is recorded. Three trials will be given to the participating woman and the highest scores will be recorded.	Up to 2 months
Modified push up test for upper body endurance	The pregnant woman will perform a short warm up before performing a fitness testing. Push up measure the muscular endurance of the upper body muscles to include the shoulders, chest and back of the upper arms. This fitness area is related to the use of force involving pushing motion. Modified push up will be performed with flexed knee and continued until failure (e.g. inability to continue due to muscle fatigue). Recruits assume a push up position with feet together or up to twelve inches apart. Hands will placed approximately shoulder width apart with fingers facing forward. A partner recruit will be in a position to extend a fist on the floor directly underneath the testing recruit's sternum. A proper push up is when the testing recruit lowers the body and touches the fist with sternum then returns up to the starting position with the elbows in a soft lock. Proper form is closely monitored. Three trails will be given to the participating woman and the highest will be recorded.	Up to 2 months
Wall squat test for muscular strength	The pregnant woman will perform a short warm -up before performing a fitness testing. This test will be used to test the quadriceps strength. To undertake this test the researcher requires a warm dry location-gym, smooth wall, stopwatch assistant. The Wall Squat test will be conducted as follows, the participating woman will stand comfortable on both feet with back against a smooth wall slide back down the wall, there is to be a 90°angle at the hip and knee, when the participating woman is ready lift one foot 5cm off the ground, the assistant starts the stopwatch as long as possible. The watch is stopped when they put their foot back on the ground; the researcher takes a test and then repeats the test with the other leg. The best time result will be recorded as a score in the second.	Up to 2 months
Chair stand test for muscular fitness	This test measures leg strength and endurance. The equipment required is a straight back or folding chair without arm rests (seat 17 inches/ 44 cm high). Place the chair against a wall , or otherwise stabilize it for safety. The pregnant woman will sit in the middle of the seat , with her feet shoulder width apart, flat on the floor. The arms will be crossed at the wrists and held close to the chest. From the sitting position , she will stand completely up, then completely back down , and this will be repeated for 30 seconds.	Up to 2 months
Steady state test for cardiovascular fitness	This test measures how you can maintain your effort for longer periods. This test is sustained for an extended time usually starting at about 10 to 15 minutes at a fixed intensity. In this study we will choose walking form. The pregnant woman will be start with 15 minutes and shoot for a target heart rate of lower than 55% of her maximum heart rate. Gradually she will be increase her steady state training to a 20 minutes cardio routine , eventually going up to 30 minutes.	Up to 2 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 30, 2022
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): October 30, 2022

Study Registration Dates

• First Submitted: July 3, 2022
• First Submitted That Met QC Criteria: July 19, 2022
• First Posted (Actual): July 22, 2022

Study Record Updates

• Last Update Posted (Actual): July 22, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 012/003729

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No