NCT05644613

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 9, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

December 15, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

3 months

First QC Date

December 1, 2022

Last Update Submit

January 24, 2023

Conditions

Keywords

premenstrual syndrome

Outcome Measures

Primary Outcomes (1)

  • Premenstrual syndrome symptoms

    PREMENSTRUAL SYNDROME QUESTIONNAIRE

    3 months

Study Arms (2)

GROUP A

ACTIVE COMPARATOR

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.

Other: aerobic exercise on land

GROUP B

ACTIVE COMPARATOR

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

Other: aerobic exercise in water

Interventions

aerobic exercise on land in form of walking on the treadmill

GROUP A

aerobic exercises in water in form of walking on the treadmill

GROUP B

Eligibility Criteria

Age14 Years - 17 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Badr University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

ExerciseWater

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Mina Atef, Phd

    Badr University

    STUDY DIRECTOR

Central Study Contacts

MARIAM Dr EL EBRASHY, Phd

CONTACT

hend sakr, Phd

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lectruer

Study Record Dates

First Submitted

December 1, 2022

First Posted

December 9, 2022

Study Start

December 15, 2022

Primary Completion

March 2, 2023

Study Completion

April 30, 2023

Last Updated

January 26, 2023

Record last verified: 2023-01

Locations