- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05644613
Comparative Study Between The Effect Of Aerobic Exercises On Land and Aerobic Exercises In Water On PMS Syndrome
January 24, 2023 updated by: Mariam Hossam El Ebrashy
Effect Of Aerobic Exercises On Land Versus Aerobic Exercises In Water In The Management Of Premenstrual Syndrome In Adolescent Girls
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: MARIAM Dr EL EBRASHY, Phd
- Phone Number: +2 01001716570
- Email: Mariam.elabrashi@buc.edu.eg
Study Contact Backup
- Name: hend sakr, Phd
- Phone Number: +2 01003501013
- Email: hend.reda@buc.edu.eg
Study Locations
-
-
-
Cairo, Egypt
- Recruiting
- Badr University
-
Contact:
- Mariam El Ebrashy, Phd
- Phone Number: 01001716570
- Email: Mariam.elabrashi@buc.edu.eg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
aerobic exercise on land in form of walking on the treadmill
|
Active Comparator: 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
|
aerobic exercises in water in form of walking on the treadmill
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Premenstrual syndrome symptoms
Time Frame: 3 months
|
PREMENSTRUAL SYNDROME QUESTIONNAIRE
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Mina Atef, Phd, Badr University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 15, 2022
Primary Completion (Anticipated)
March 2, 2023
Study Completion (Anticipated)
April 30, 2023
Study Registration Dates
First Submitted
December 1, 2022
First Submitted That Met QC Criteria
December 1, 2022
First Posted (Actual)
December 9, 2022
Study Record Updates
Last Update Posted (Estimate)
January 26, 2023
Last Update Submitted That Met QC Criteria
January 24, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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