NCT05198115

Brief Summary

The premenstrual syndrome includes physical and psychological symptoms that occur at the end menstrual cycle and exercise is one of the ways to reduce symptoms. The aim of this study was to determine the effect of a regular 8-week aerobic exercise program on psychological symptoms of premenstrual syndrome.

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

February 25, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2022

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

February 22, 2022

Status Verified

February 1, 2022

Enrollment Period

2 months

First QC Date

December 19, 2021

Last Update Submit

February 20, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Emotional (EM) scale

    emotional scale from \[0 to 10\]

    eight weeks

Study Arms (2)

Aerobic group

ACTIVE COMPARATOR

The intervention consisted of aerobic exercise training, which was taught to participants face-to-face at a meeting. At the end of the session, we provided the intervention group with CDs and educational posters containing all the exercises

Behavioral: aerobic exercise

Eight Weeks of Aerobic Exercise

PLACEBO COMPARATOR

The control group was subjected to all the pre-and post-assessments but were not asked to perform the exercise intervention. Instead, we phone-called them to give a reminder for filling out the questionnaires.

Behavioral: aerobic exercise

Interventions

aerobic training for 8 weeks, 3 times a week, and 60 min each time

Aerobic groupEight Weeks of Aerobic Exercise

Eligibility Criteria

Age18 Years - 25 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailspms only for women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • young women aged 18-25 years with a body mass index (BMI): 18-25 kg/m2, having regular menstrual cycles of 23-35 days duration, no previous practice of aerobic exercise, free from musculoskeletal injury, not using oral contraceptive pills or taking any psychotropic agents, having no depression or genital tract diseases

You may not qualify if:

  • pregnancy, contraindications to physical exercise, metabolic or cardiorespiratory illness, cigarette smokers, women who recover from a major injury or using anti-inflammatory, hyperlipidemia or hypertension medications, any abnormality in ovulation, and women with diabetes mellitus, thyroid, pituitary, or ovarian disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Eight Weeks of Aerobic Exercise
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr ahmedsaidali MCs candidate Principal Investigator

Study Record Dates

First Submitted

December 19, 2021

First Posted

January 20, 2022

Study Start

February 25, 2022

Primary Completion

April 25, 2022

Study Completion

April 30, 2022

Last Updated

February 22, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share