NCT05469763

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 22, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

July 30, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
Last Updated

July 22, 2022

Status Verified

July 1, 2022

Enrollment Period

2 months

First QC Date

July 3, 2022

Last Update Submit

July 19, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Sit and reach flexibility test

    Up to 2 months

  • Modified push up test for upper body endurance

    Up to 2 months

  • Wall squat test for muscular strength

    Up to 2 months

  • Chair stand test for muscular fitness

    Up to 2 months

  • Steady state test for cardiovascular fitness

    Up to 2 months

Study Arms (2)

Circuit training exercise plus calcium tablets group

EXPERIMENTAL

Study Group: they will receive circuit training exercise, 3 sessions per week for 12 weeks, in addition to calcium supplements.

Other: Circuit training

Calcium tablets group

OTHER

Control Group: they will receive daily dosage of calcium supplements 1-3 g/ day

Other: Circuit training

Interventions

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.

Calcium tablets groupCircuit training exercise plus calcium tablets group

Eligibility Criteria

Age20 Years - 30 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Circuit-Based Exercise

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Manal Ahmed Elshafei, lecturer

CONTACT

Manal Ahmed Elshafei

CONTACT

Study Design

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

Study Record Dates

First Submitted

July 3, 2022

First Posted

July 22, 2022

Study Start

July 30, 2022

Primary Completion

September 30, 2022

Study Completion

October 30, 2022

Last Updated

July 22, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF