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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: fahiema me okeel, professor
  • Phone Number: 01013738980

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 1, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings