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

Primary Purpose

Premenstrual Syndrome

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
whole body vibration
aerobic exercise
supplementation
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premenstrual Syndrome focused on measuring whole body vibration, aerobic exercises, premenstrual syndrome

Eligibility Criteria

18 Years - 25 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Al Shaymaa Shaaban Abd El Azeim

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

whole body vibration

aerobic exercise

supplementations

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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

Full Information

First Posted
April 7, 2021
Last Updated
July 20, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04855981
Brief Title
Whole-body Vibration Versus Aerobic Exercise on the Inflammatory Status and Hormonal Parameters Premenstrual Syndrome
Acronym
PMS
Official Title
Effect of Whole-body Vibration Versus Aerobic Exercise on the Inflammatory Status and Hormonal Parameters in Females With Premenstrual Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 15, 2021 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome
Keywords
whole body vibration, aerobic exercises, premenstrual syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
whole-body vibration and aerobic exercise
Masking
ParticipantOutcomes Assessor
Masking Description
random generator
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
whole body vibration
Arm Type
Experimental
Arm Description
the subjects will receive whole-body vibration three times per week for twelve weeks +supplementations
Arm Title
aerobic exercise
Arm Type
Experimental
Arm Description
the subjects will receive aerobic exercise three times per week for twelve weeks+supplementations
Arm Title
supplementations
Arm Type
Active Comparator
Arm Description
the subjects will receive supplementations three times per week for twelve weeks
Intervention Type
Other
Intervention Name(s)
whole body vibration
Intervention 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
Intervention Type
Other
Intervention Name(s)
aerobic exercise
Intervention Description
the subjects will receive aerobic exercises+ magnesium (Mg) (250 g) and vitamin B6 supplementation
Intervention Type
Other
Intervention Name(s)
supplementation
Intervention Description
the subjects will receive magnesium (Mg) (250 g) and vitamin B6 supplementation
Primary Outcome Measure Information:
Title
premenstrual symptoms
Description
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
Time Frame
up to twelve weeks
Secondary Outcome Measure Information:
Title
CRP level assessment
Description
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.
Time Frame
up to twelve weeks
Title
cortisol level
Description
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.
Time Frame
up to twelve weeks
Title
hormonal analysis
Description
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
Time Frame
up to twelve weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Al Shaymaa Shaaban Abd El Azeim
City
Giza
ZIP/Postal Code
12511
Country
Egypt

12. IPD Sharing Statement

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

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