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Comparative Study Between The Effect Of Aerobic Exercises On Land and Aerobic Exercises In Water On PMS Syndrome

Primary Purpose

Premenstrual Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
aerobic exercise on land
aerobic exercise in water
Sponsored by
Mariam Hossam El Ebrashy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premenstrual Syndrome focused on measuring premenstrual syndrome

Eligibility Criteria

14 Years - 17 Years (Child)FemaleAccepts Healthy Volunteers

Inclusion Criteria: All participants virgin females. Their age ranged from 14 to 17 years old their body mass index (BMI) ≥ 18 ≤ 25 kg/m2. They are clinically and medically stable during the study, they have regular menstrual cycle of 23 to 35 days and not participated any type of unusual diet during the period of the study. Exclusion Criteria: All females in this study are free from: cardiopulmonary or orthopaedic problems, taking any hormonal drugs for three months at least, participating in any form of activity rather than the prescribed one in the study, any abnormality in ovulation or pelvic inflammatory diseases (PID).

Sites / Locations

  • Badr UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

GROUP A

GROUP B

Arm Description

will consist of (20) adolescent girls age ranged from 14-17 suffering from PMS without any pathological cause they will receive an aerobic exercise on land in form of walking on the treadmill for 20 min 3 times per week for 3 months.

will consist of (20) adolescent girls age ranged from 14-17 suffering from PMS without any pathological cause they will receive an aerobic exercises in water in form of walking on the treadmill for 20 min 3 times per week for 3 months

Outcomes

Primary Outcome Measures

Premenstrual syndrome symptoms
PREMENSTRUAL SYNDROME QUESTIONNAIRE

Secondary Outcome Measures

Full Information

First Posted
December 1, 2022
Last Updated
January 24, 2023
Sponsor
Mariam Hossam El Ebrashy
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1. Study Identification

Unique Protocol Identification Number
NCT05644613
Brief Title
Comparative Study Between The Effect Of Aerobic Exercises On Land and Aerobic Exercises In Water On PMS Syndrome
Official Title
Effect Of Aerobic Exercises On Land Versus Aerobic Exercises In Water In The Management Of Premenstrual Syndrome In Adolescent Girls
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2022 (Actual)
Primary Completion Date
March 2, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mariam Hossam El Ebrashy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Many girls experience premenstrual syndrome PMS which is re a group of physical, cognitive, affective, and behavioural symptoms that occur cyclically during the luteal phase of the menstrual cycle and resolve at or within a few days of the onset of menstruation. In young adolescents symptoms might particularly affect school functions, and social interactions in a negative ways in this study we will figure out the effect of 2 kinds of exercises in the management of this syndrome.
Detailed Description
Fourty adolescent girls were divided randomly into two equal groups, Group (A) will consist of (20) adolescent girls age ranged from 14-17 suffering from PMS without any pathological cause they will receive an aerobic exercise on land in form of walking on the treadmill for 20 min 3 times per week for 3 months. Group (B) will consist of (20) adolescent girls age ranged from 14-17 suffering from PMS without any pathological cause they will receive an aerobic exercises in water in form of walking on the treadmill for 20 min 3 times per week for 3 months the assessment of the PMS symptoms will be done by Premenstrual distress questionnaire

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome
Keywords
premenstrual syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GROUP A
Arm Type
Active Comparator
Arm Description
will consist of (20) adolescent girls age ranged from 14-17 suffering from PMS without any pathological cause they will receive an aerobic exercise on land in form of walking on the treadmill for 20 min 3 times per week for 3 months.
Arm Title
GROUP B
Arm Type
Active Comparator
Arm Description
will consist of (20) adolescent girls age ranged from 14-17 suffering from PMS without any pathological cause they will receive an aerobic exercises in water in form of walking on the treadmill for 20 min 3 times per week for 3 months
Intervention Type
Other
Intervention Name(s)
aerobic exercise on land
Intervention Description
aerobic exercise on land in form of walking on the treadmill
Intervention Type
Other
Intervention Name(s)
aerobic exercise in water
Intervention Description
aerobic exercises in water in form of walking on the treadmill
Primary Outcome Measure Information:
Title
Premenstrual syndrome symptoms
Description
PREMENSTRUAL SYNDROME QUESTIONNAIRE
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All participants virgin females. Their age ranged from 14 to 17 years old their body mass index (BMI) ≥ 18 ≤ 25 kg/m2. They are clinically and medically stable during the study, they have regular menstrual cycle of 23 to 35 days and not participated any type of unusual diet during the period of the study. Exclusion Criteria: All females in this study are free from: cardiopulmonary or orthopaedic problems, taking any hormonal drugs for three months at least, participating in any form of activity rather than the prescribed one in the study, any abnormality in ovulation or pelvic inflammatory diseases (PID).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MARIAM Dr EL EBRASHY, Phd
Phone
01001716570
Ext
+2
Email
Mariam.elabrashi@buc.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
hend sakr, Phd
Phone
01003501013
Ext
+2
Email
hend.reda@buc.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mina Atef, Phd
Organizational Affiliation
Badr University
Official's Role
Study Director
Facility Information:
Facility Name
Badr University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariam El Ebrashy, Phd
Phone
01001716570
Email
Mariam.elabrashi@buc.edu.eg

12. IPD Sharing Statement

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Comparative Study Between The Effect Of Aerobic Exercises On Land and Aerobic Exercises In Water On PMS Syndrome

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