Clinical trial NCT05707845: Effect of Weight Reduction and Aerobic Exercise on PMS Symptoms in Obese Females
Official title: Effect of Weight Reduction and Aerobic Exercise on Premenstrual Syndrome Symptoms in Obese Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premenstrual Syndrome
Keywords: "premenstrual syndrome"
"diet"
"exercise"
"obesity"
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * Two groups pre-test post-test design.
* In this study the patients will be randomly assigned into two equal groups (20 patients for each group).

  (a) Group A: (control group):
* Medical treatment in the form of nonsteroidal anti-inflammatory drugs (NSAIDs). (b) Group B: (Study group):
* Medical treatment in the form of nonsteroidal anti-inflammatory drugs (NSAIDs).
* Physical therapy program weight reduction by diet program in the form of caloric restriction, in combination to aerobic exercise in the form of using treadmill 30 minutes /3 times a week for 12 weeks.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progesterone levels in blood
timeFrame: 12 weeks
measure: body weight
timeFrame: 12 weeks
measure: cortisol levels in blood
timeFrame: 12 weeks
measure: Premenstrual syndrome score
timeFrame: 12 weeks
measure: Waist and hip circumference measurements
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Yara Mostafa Soliman
Study officials:
affiliation: Cairo University
name: amal mo youseef, professor
role: STUDY_DIRECTOR
References:
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.
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.
citation: 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.