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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04901598
Other study ID # p.t.REC/012/003220
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 20, 2021
Est. completion date March 25, 2022

Study information

Verified date July 2022
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Description:

premenstrual syndrome can be defined as a recurrent disorder that occurs every month in the luteal phase of the menstrual cycle, and subside with the onset of menstruation. It is characterized by a complex set of symptoms, which include physical, psychological and behavioral changes with varying severity. This can interfere with the lives of females. Physical exercise improves PMS through rising endorphin levels, reducing adrenal cortisol symptoms, leading to lesser anxiety, depression and greater pain tolerance, as previous studies showed that it was effective in decreasing pain as well as mental and physical symptoms of PMS. Recently, lifestyle changes have gained more importance than pharmacotherapy. Lifestyle changes include many methods including diet regulation and exercise. 30 minutes of aerobic exercise is recommended for at least 3 days per week to contribute to the regulation of both body composition, mood and to improve physical symptoms. Evidence suggests that it can be helpful in reducing symptoms.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date March 25, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 35 Years
Eligibility Inclusion Criteria: - 1-suffering from PMS (as determined by PMS scale) 2-Their ages range from 20 to 35 years 3-Having regular menstrual cycle Exclusion Criteria: - 1-Smoking 2-Following any special diet 3-Taking any medication 4-History of chronic disease 5-Having any psychiatric or gynecological problems

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Running anaerobic sprint test and aerobic test
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)

Locations

Country Name City State
Egypt Nisreen Ashraf Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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

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

Outcome

Type Measure Description Time frame Safety issue
Primary 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 aerobic test subject walk back and forth 6 times with maximum speed a distance of 35 meters, between every 35 meters, 10 seconds of rest will be considered 6 minutes
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