Effect of Weight Reduction and Aerobic Exercise on PMS Symptoms in Obese Females

Premenstrual Syndrome Clinical Trial

— PMS  

Official title:

Effect of Weight Reduction and Aerobic Exercise on Premenstrual Syndrome Symptoms in Obese Females

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05707845
• Other study ID #: 012/003813
• Status: Completed
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: June 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study will be investigation of the effect of weight reduction and aerobic exercises on premenstrual syndrome symptoms in obese females.

Description:

both groups (A&B) will take their medical treatment in the form of (NSAIDs) and the study group B will under go a siet plan which will fits the participants. Diet plan extends for 12 weeks in the form of caloric restriction program and each woman in group B will perform aerobic exercise program, in the form of treadmill 3 times/week for 8 weeks for 12 weeks. Each session will take about 30 minutes as the following: 5 minutes warming up exercises by walking on the treadmill by low speed, 20 minutes walking at moderate intensity (70% of the maximal heart rate) and 5 minutes are cooling down by walking on the treadmill by low speed as in warming up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 30 Years

Eligibility

Inclusion Criteria:

• Age will range between 20- 30 years old.

• only females will participate in the study.

• All patients who will be enrolled to the study will have their informed consent.

Exclusion Criteria:

• Diabetes mellitus.

• Individuals with cardiopulmonary conditions.

• Individuals with any pelvic disease.

• Individuals undergoing radiation therapy or chemotherapy.

• Hepatic or pancreatic diseases.

Related Conditions & MeSH terms

• Premenstrual Syndrome
• Syndrome
• Weight Loss

Intervention

Drug:
• Medical treatment.
Medical treatment in the form of nonsteroidal anti-inflammatory drugs (NSAIDs).

Behavioral:
• weight reduction
weight reduction in the form low caloric diet program for 12 weeks.

Other:
• exercise
aerobic exercise in the form of walking on treadmill for 30 minutes 3 times a week for 12 weeks.

Locations

Country	Name	City	State
Egypt	Yara Mostafa Soliman	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Itriyeva K. The effects of obesity on the menstrual cycle. Curr Probl Pediatr Adolesc Health Care. 2022 Aug;52(8):101241. doi: 10.1016/j.cppeds.2022.101241. Epub 2022 Jul 21. — View Citation

Quintana-Zinn FA, Whitcomb BW, Ronnenberg AG, Bigelow C, Houghton SC, Bertone-Johnson ER. Premenstrual Symptom Patterns and Behavioral Risk Factors in Young Women: A Cross-Sectional Study. J Womens Health (Larchmt). 2017 Oct;26(10):1099-1105. doi: 10.1089/jwh.2016.5921. Epub 2017 Jun 26. — View Citation

Vaghela N, Mishra D, Sheth M, Dani VB. To compare the effects of aerobic exercise and yoga on Premenstrual syndrome. J Educ Health Promot. 2019 Oct 24;8:199. doi: 10.4103/jehp.jehp_50_19. eCollection 2019. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progesterone levels in blood	progesterone level will be checked six to eight days after ovulation start (about day 21st of a 28-day cycle)	12 weeks
Primary	body weight	Weight and height measurement will be measured while the woman is wearing a thin layer of clothes to calculate the BMI according to the following equation for both groups (A&B): BMI = weight/height2 (kg/m2).	12 weeks
Primary	cortisol levels in blood	All women in both groups (A&B) will be evaluated before and after the treatment (12 weeks) to show serum cortisol level. A blood sample was taken from each female in both groups (A & B) before and after the treatment to measure the serum cortisol levels, which could reflect anxiety and pain intensity with decreased cortisol levels indicating decreased pain intensity. The cortisol level was assessed 5 days before the first day of the menstrual cycle preceding the treatment program and 5 days before the first day of the menstrual cycle at the end of treatment program,Blood sample of about 5 cm was drawn from the anticubital vein from all participants by disposable sterile syringe by vein puncture to determine plasma cortisol level. All blood samples were taken at 8-9 am and the norm cortisol level at 9 A.M ranges from 4.3-22.4 ug/dl.	12 weeks
Primary	Premenstrual syndrome score	The premenstrual syndrome scale comprised 40 questions with three sub-scales (Physiological, Psychological and Behavioural symptoms). This 5-point Likert- type scale consisting of 40 items. The measurements on the scale are set according to the following scoring system: the response Never was scored as "1", rarely as "2", sometimes as "3", very often as "4" and always as "5" points, the total score obtained from the sub-scales established the "PMSS total score." The scale's lowest score is 40 and highest score is 200. If the scale's total score reached 80 points or above, this indicates the occurrence of PMS. Increases in the scores indicate an increase in PMS severity.	12 weeks
Primary	Waist and hip circumference measurements	Waist circumference was measured at the narrowest point between xipho-sternum and the iliac crest at the end of a gentle expiration; hip circumference was measured at the maximum circumference at the level of femoral trochanter. Then, waist/hip ratio was calculated by dividing waist circumference on hip circumference. All measurements were taken for all patients in both groups (A&B), while the patient was in the standing position, before starting and after the end of the treatment course.	12 weeks