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

June 8, 2024 updated by: Yara Mostafa Soliman Mahmoud Abdlbary, Cairo University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

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

  • Egypt
      • Cairo, Egypt
        • Yara Mostafa Soliman

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 30 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: control group (A)
Group A: (control group): 20 participants Medical treatment in the form of nonsteroidal anti-inflammatory drugs (NSAIDs)
Drug: Medical treatment.
Medical treatment in the form of nonsteroidal anti-inflammatory drugs (NSAIDs).
Other Names:
  • NSAID
Experimental: study group (B)

Group B: (Study group): 20 participants

  • 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.
Drug: Medical treatment.
Medical treatment in the form of nonsteroidal anti-inflammatory drugs (NSAIDs).
Other Names:
  • NSAID
Behavioral: weight reduction
weight reduction in the form low caloric diet program for 12 weeks.
Other Names:
  • diet program
Other: exercise
aerobic exercise in the form of walking on treadmill for 30 minutes 3 times a week for 12 weeks.
Other Names:
  • aerobic exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progesterone levels in blood
Time Frame: 12 weeks
progesterone level will be checked six to eight days after ovulation start (about day 21st of a 28-day cycle)
12 weeks
body weight
Time Frame: 12 weeks

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
cortisol levels in blood
Time Frame: 12 weeks
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
Premenstrual syndrome score
Time Frame: 12 weeks
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
Waist and hip circumference measurements
Time Frame: 12 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: amal mo youseef, professor, Cairo University

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

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)

May 1, 2023

Primary Completion (Actual)

August 1, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

January 8, 2023

First Submitted That Met QC Criteria

January 22, 2023

First Posted (Actual)

February 1, 2023

Study Record Updates

Last Update Posted (Actual)

June 11, 2024

Last Update Submitted That Met QC Criteria

June 8, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 012/003813

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.

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