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: April 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	pain level	A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain.; From the patient's perspective this spectrum appears continuous ± their pain does not take discrete jumps, as a categorization of none, mild, moderate and severe would suggest. It was to capture this idea of an underlying continuum that the VAS was devised. Operationally a VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks	12 weeks
Primary	Oswestry disability index (ODI)	it is valid and reliable tool for measuring the functional disability in patients with LBP, it consists of ten questions including the daily functional disability, each question includes six choices, the patient select the best one which describe her disability, the maximum score in this study was 45, then all scores collected and taken as percentage from the total score, the higher score indicates greater disability, scores from 0-20% indicate minimal disability, scores from 40-60% indicate moderate disability, scores from 60-80% indicate crippled disability and scores from 80-100% represent patient who are confined to bed.	12 weeks