NCT04901598

Brief Summary

The aim of the study is to investigate the physical activity level, aerobic capacity and dietary habits among a cohort of females with premenstrual syndrome

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

May 20, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 25, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

October 20, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2022

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

2 months

First QC Date

May 20, 2021

Last Update Submit

July 18, 2022

Conditions

Premenstrual Syndrome

Keywords

physical activity level, aerobic capacity and dietary habits in PMS

Outcome Measures

Primary Outcomes (1)

  • Assessment of premenstrual syndrome

    premenstrual syndrome scale consist of 2 sections and 19 questions about symptoms of PMS, it will be rated on the scale as not at all, mild, moderate or severe

    5 minutes

Secondary Outcomes (1)

  • aerobic test

    6 minutes

Interventions

Running anaerobic sprint test and aerobic testOTHER

subjects walk a mile with maximum steps and their heart rate will not exceed 180 beats per minute during the test and the execution time will not be less than 9 minutes (RAST test)

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

females with PMS will participate in this study with ages ranging from 20 to 35 years

You may qualify if:

  • suffering from PMS (as determined by PMS scale) 2-Their ages range from 20 to 35 years 3-Having regular menstrual cycle

You may not qualify if:

  • Smoking 2-Following any special diet 3-Taking any medication 4-History of chronic disease 5-Having any psychiatric or gynecological problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nisreen Ashraf

Giza, 12511, Egypt

Location

Related Publications (2)

  • Hofmeister S, Bodden S. Premenstrual Syndrome and Premenstrual Dysphoric Disorder. Am Fam Physician. 2016 Aug 1;94(3):236-40.

    PMID: 27479626BACKGROUND

  • Biggs WS, Demuth RH. Premenstrual syndrome and premenstrual dysphoric disorder. Am Fam Physician. 2011 Oct 15;84(8):918-24.

    PMID: 22010771BACKGROUND

Related Links

MeSH Terms

Conditions

Premenstrual Syndrome

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

May 20, 2021

First Posted

May 25, 2021

Study Start

October 20, 2021

Primary Completion

January 1, 2022

Study Completion

March 25, 2022

Last Updated

July 20, 2022

Record last verified: 2022-07

Locations

EG(1)