- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04901598
Physical Activity Level, Aerobic Capacity and Dietary Habits Among a Cohort of Females With Premenstrual Syndrome
July 18, 2022 updated by: Nisreen Ashraf, Cairo University
Physical Activity Level, Aerobic Capacity and Dietary Habits Among a Cohort of Females With Premenstrual Syndrome: an Observational Study
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Giza, Egypt, 12511
- Nisreen Ashraf
-
-
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
20 years to 35 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
females with PMS will participate in this study with ages ranging from 20 to 35 years
Description
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 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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of premenstrual syndrome
Time Frame: 5 minutes
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
aerobic test
Time Frame: 6 minutes
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
Helpful Links
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)
October 20, 2021
Primary Completion (ACTUAL)
January 1, 2022
Study Completion (ACTUAL)
March 25, 2022
Study Registration Dates
First Submitted
May 20, 2021
First Submitted That Met QC Criteria
May 20, 2021
First Posted (ACTUAL)
May 25, 2021
Study Record Updates
Last Update Posted (ACTUAL)
July 20, 2022
Last Update Submitted That Met QC Criteria
July 18, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- p.t.REC/012/003220
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.
Clinical Trials on Premenstrual Syndrome
-
Esra ÖZERKTO Karatay UniversityRecruitingPremenstrual Syndrome-PMSTurkey
-
Shaare Zedek Medical CenterUnknownPremenstrual Syndrome-PMS
-
Philipps University Marburg Medical CenterLinkoeping UniversityCompletedPremenstrual Syndrome (PMS)Germany
-
Cairo UniversityNot yet recruitingPremenstrual Tension
-
Cairo UniversityNot yet recruitingPremenstrual Pain
-
Terra Biological LLCCompletedPremenstrual Syndrome (PMS)
-
Massachusetts General HospitalWithdrawnPremenstrual Dysphoric Disorder | Premenstrual Syndrome | Premenstrual Tension | Menstrual Related Mood DisorderUnited States
-
Tel-Aviv Sourasky Medical CenterUnknownDepression | Premenstrual Dysphoric Disorder (PMDD)Israel
-
Yale UniversityNational Institute of Mental Health (NIMH)CompletedPremenstrual SyndromeUnited States
Clinical Trials on Running anaerobic sprint test and aerobic test
-
Ankara Yildirim Beyazıt UniversityCompletedSports Physical TherapyTurkey
-
Hillel Yaffe Medical CenterUniversity of Haifa; Zinman College of Physical Education and Sports SciencesUnknown
-
Meir Medical CenterUnknown
-
Hvidovre University HospitalCompletedHamstring Injury | Sprint PerformanceDenmark
-
Hillel Yaffe Medical CenterUnknown
-
University of Sao Paulo General HospitalInstituto Dante Pazzanese de CardiologiaUnknownCongestive Heart FailureBrazil
-
Samsung Medical CenterCompletedAerobic Exercises | Anaerobic ExercisesKorea, Republic of
-
Fondazione Don Carlo Gnocchi OnlusUniversita di Verona; Microgate SrlCompleted
-
Institute of Sport - National Research Institute...Completed
-
Texas Tech University Health Sciences Center, El...American College of GastroenterologyCompletedCholangiocarcinoma | Choledocholithiasis | Benign Stricture of Common Bile DuctUnited States