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Completed

NCT Number: NCT05707845

Effect of Weight Reduction and Aerobic Exercise on PMS 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.

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Key information

Age range

20 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yara Mostafa Soliman

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Medical treatment.

Drug

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

Other names: NSAID

weight reduction

Behavioral

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

Other names: diet program

Exercise

Other

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

Other names: aerobic exercise

Primary outcomes

  1. 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)

  2. 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).

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Acronym: PMS

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 1, 2023
Registry last updated
Jun 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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