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

NCT ID: NCT04855981

Last Updated: 2024-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-15

Study Completion Date

2022-05-30

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

Conditions

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Premenstrual Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

whole-body vibration and aerobic exercise
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
random generator

Study Groups

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whole body vibration

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

Group Type EXPERIMENTAL

whole body vibration

Intervention Type OTHER

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

supplementation

Intervention Type OTHER

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

aerobic exercise

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

Group Type EXPERIMENTAL

aerobic exercise

Intervention Type OTHER

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

supplementation

Intervention Type OTHER

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

supplementations

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

Group Type ACTIVE_COMPARATOR

supplementation

Intervention Type OTHER

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

Interventions

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whole body vibration

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

Intervention Type OTHER

aerobic exercise

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

Intervention Type OTHER

supplementation

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Al Shaymaa Shaaban Abd El Azeim

Principale investigator. al shaymaa shaaban abd el azeim

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Al Shaymaa Shaaban Abd El Azeim

Giza, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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p.t.REC/012/003183

Identifier Type: -

Identifier Source: org_study_id

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