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

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

Sponsors

Lead Sponsor: Cairo University

Source Cairo University
Brief Summary

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

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

Overall Status Not yet recruiting
Start Date 2021-04-30
Completion Date 2021-08-30
Primary Completion Date 2021-08-30
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
premenstrual symptoms up to twelve weeks
Secondary Outcome
Measure Time Frame
CRP level assessment up to twelve weeks
cortisol level up to twelve weeks
hormonal analysis up to twelve weeks
Enrollment 60
Condition
Intervention

Intervention Type: Other

Intervention Name: whole body vibration

Description: 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

Arm Group Label: whole body vibration

Intervention Type: Other

Intervention Name: aerobic exercise

Description: the subjects will receive aerobic exercises+ magnesium (Mg) (250 g) and vitamin B6 supplementation

Arm Group Label: aerobic exercise

Intervention Type: Other

Intervention Name: supplementation

Description: the subjects will receive magnesium (Mg) (250 g) and vitamin B6 supplementation

Eligibility

Criteria:

Inclusion Criteria: 1. Females suffering from PMS (as determined by PMS scale). 2. Their ages will range from 18 to 25 years. 3. Having regular menstrual cycle. Exclusion Criteria: 1. Smoking. 2. Taking any medications. 3. History of chronic disease. 4. Having any psychiatric or gynecological problems

Gender:

Female

Minimum Age:

18 Years

Maximum Age:

25 Years

Healthy Volunteers:

No

Location
Facility: Contact: Contact Backup: Al Shaymaa Shaaban Abd El Azeim al shaymaa sh abd el azeim, lecturer 01033771553 [email protected]
Location Countries

Egypt

Verification Date

2021-04-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Cairo University

Investigator Full Name: Al Shaymaa Shaaban Abd El Azeim

Investigator Title: Principale investigator. al shaymaa shaaban abd el azeim

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: whole body vibration

Type: Experimental

Description: the subjects will receive whole-body vibration three times per week for twelve weeks +supplementations

Label: aerobic exercise

Type: Experimental

Description: the subjects will receive aerobic exercise three times per week for twelve weeks+supplementations

Label: supplementations

Type: Active Comparator

Description: the subjects will receive supplementations three times per week for twelve weeks

Acronym PMS
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: whole-body vibration and aerobic exercise

Primary Purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Masking Description: random generator

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