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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Premenstrual Syndrome

Intervention / Treatment
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* Drug: Medical treatment.
* Behavioral: weight reduction
* Other: exercise


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control group (A)<br>Group A: (control group): 20 participants Medical treatment in the form of nonsteroidal anti-inflammatory drugs (NSAIDs) | Drug: Medical treatment.<br>* Medical treatment in the form of nonsteroidal anti-inflammatory drugs (NSAIDs).<br>* Other names: NSAID;|
| Experimental: study group (B)<br>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.<br>* Medical treatment in the form of nonsteroidal anti-inflammatory drugs (NSAIDs).<br>* Other names: NSAID;Behavioral: weight reduction<br>* weight reduction in the form low caloric diet program for 12 weeks.<br>* Other names: diet program;Other: exercise<br>* aerobic exercise in the form of walking on treadmill for 30 minutes 3 times a week for 12 weeks.<br>* Other names: aerobic exercise;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Premenstrual syndrome questionnaire (PSQ): | Premenstrual symptoms comprise a wide range of mood, behavioral, and physical symptoms occurring during the luteal phase. The PPSQ, is a patient-reported outcome measurement tool to detect the severity of premenstrual symptoms. The PMS scales assess ten domains of symptoms: the observer rates the 10 domains by severity with a range of 0 to 4 in eight domains and 0 to 2 in two domains, for a maximum total score of 36. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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premenstrual syndrome, diet, exercise, obesity