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

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT04855981

Collaborator

(none)

105

Enrollment

Location

Arms

5.5

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Premenstrual Syndrome	Other: whole body vibration Other: aerobic exercise Other: supplementation	N/A

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

Study Design

Study Type:

Interventional

Actual Enrollment :

105 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

whole-body vibration and aerobic exercisewhole-body vibration and aerobic exercise

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

random generator

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 15, 2021

Actual Primary Completion Date :

Sep 30, 2021

Actual Study Completion Date :

Sep 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: whole body vibration the subjects will receive whole-body vibration three times per week for twelve weeks +supplementations	Other: 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 Other: supplementation the subjects will receive magnesium (Mg) (250 g) and vitamin B6 supplementation
Experimental: aerobic exercise the subjects will receive aerobic exercise three times per week for twelve weeks+supplementations	Other: aerobic exercise the subjects will receive aerobic exercises+ magnesium (Mg) (250 g) and vitamin B6 supplementation Other: supplementation the subjects will receive magnesium (Mg) (250 g) and vitamin B6 supplementation
Active Comparator: supplementations the subjects will receive supplementations three times per week for twelve weeks	Other: supplementation the subjects will receive magnesium (Mg) (250 g) and vitamin B6 supplementation

Arm

Intervention/Treatment

Experimental: whole body vibration

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

Other: 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

Other: supplementation

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

Experimental: aerobic exercise

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

Other: aerobic exercise

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

Other: supplementation

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

Active Comparator: supplementations

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

Other: supplementation

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

Outcome Measures

Primary Outcome Measures

premenstrual symptoms [up to twelve weeks]
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

Secondary Outcome Measures

CRP level assessment [up to twelve weeks]
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.
cortisol level [up to twelve weeks]
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.
hormonal analysis [up to twelve weeks]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 25 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Al Shaymaa Shaaban Abd El Azeim	Giza		Egypt	12511

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Al Shaymaa Shaaban Abd El Azeim, Principale investigator. al shaymaa shaaban abd el azeim, Cairo University

ClinicalTrials.gov Identifier:

NCT04855981

Other Study ID Numbers:

p.t.REC/012/003183

First Posted:

Apr 22, 2021

Last Update Posted:

Jul 21, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Al Shaymaa Shaaban Abd El Azeim, Principale investigator. al shaymaa shaaban abd el azeim, Cairo University

whole body vibration

aerobic exercises

premenstrual syndrome

Additional relevant MeSH terms:

Syndrome

Premenstrual Syndrome

Study Results

No Results Posted as of Jul 21, 2022