Whole-body Vibration Versus Aerobic Exercise on the Inflammatory Status and Hormonal Parameters Premenstrual Syndrome

Study Overview
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Brief Summary
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The purpose of this study is to investigate and compare the effect of whole-body vibration to aerobic exercise on inflammatory status in females with premenstrual syndrome.

Detailed Description
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Premenstrual syndrome (PMS) is a complex disorder characterized by moderate to severe symptoms taking place during the luteal phase of the menstrual cycle. It has a negative impact on females' lives, which can affect their relationships, educational efficiency, social activities, and quality of life. Despite previous studies reported that physical exercise improves the symptoms of PMS, the effects of physical exercise on inflammatory status in females with PMS are not clear yet. sixty females allocated to three groups randomly to group (A) that will receive whole-body vibration+supplementation, group (B) that will receive aerobic exercises+supplementation, and group c that will receive supplementation only

Official Title
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Effect of Whole-body Vibration Versus Aerobic Exercise on the Inflammatory Status and Hormonal Parameters in Females With Premenstrual Syndrome

Conditions
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Premenstrual Syndrome

Intervention / Treatment
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* Other: whole body vibration
* Other: aerobic exercise
* Other: supplementation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females suffering from PMS (as determined by PMS scale). Their ages will range from 18 to 25 years. Having regular menstrual cycle. Exclusion Criteria: Smoking. Taking any medications. History of chronic disease. Having any psychiatric or gynecological problems

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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: whole-body vibration and aerobic exercise
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: whole body vibration<br>the subjects will receive whole-body vibration three times per week for twelve weeks +supplementations | Other: whole body vibration<br>* All participants in the WBV group will perform the WBV training on a vibrating device (Confidence Vibration Plate Power Plus, China), which produces a lateral peak-to-peak oscillation. They will stand on the WBV platform with a 150° knee angle during the exposure minute. They started the training with three sets of 1 min separated by a 1-min resting period and vibration amplitude of 1 mm. They will add one set every session until they performed 10 sets of WBV. The frequency started at 20 Hz, which will be increased gradually by 2 Hz every 2 weeks +magnesium (Mg) (250 g) and vitamin B6 supplementation<br>Other: supplementation<br>* the subjects will receive magnesium (Mg) (250 g) and vitamin B6 supplementation<br>|
| Experimental: aerobic exercise<br>the subjects will receive aerobic exercise three times per week for twelve weeks+supplementations | Other: aerobic exercise<br>* the subjects will receive aerobic exercises+ magnesium (Mg) (250 g) and vitamin B6 supplementation<br>Other: supplementation<br>* the subjects will receive magnesium (Mg) (250 g) and vitamin B6 supplementation<br>|
| Active Comparator: supplementations<br>the subjects will receive supplementations three times per week for twelve weeks | Other: supplementation<br>* the subjects will receive magnesium (Mg) (250 g) and vitamin B6 supplementation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| premenstrual symptoms | The premenstrual syndrome questionnaire also measured the occurrence and severity of two menstrual pain symptoms, including cramp and backache experienced during the first 2 days of the women' last menstrual period. Premenstrual symptoms were scaled as: mild (1); moderate (2); and severe (3). Young women with PMS should experience a premenstrual symptoms score of at least 50% greater than the postmenstrual score | up to twelve weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRP level assessment | blood sampl a normal reading is less than 10 milligram per liter (mg/L), more than 10 milligram the level of inflammation in body increase. | up to twelve weeks | 
| cortisol level | When a technician carries out the cortisol level test between 6 a.m. and 8 a.m., the results will typically be within the range of 10-20 micrograms per deciliter (mcg/dL). more than 20 the level of stress increased. | up to twelve weeks | 
| hormonal analysis | blood sample will be used for assessment the level of progesterone and prolactin. normal level of progesterone less than 0.20 ng/mL and Normal levels of prolactin in females: less than 25 ng/mL | up to twelve weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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whole body vibration, aerobic exercises, premenstrual syndrome