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

Not Applicable

Completed

• Conditions: Premenstrual Syndrome
• Interventions: Other: whole body vibration; Other: aerobic exercise; Other: supplementation

• Registration Number: NCT04855981
• Lead Sponsor: 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

Study Timeline

• Study First Submitted: 2021-04-07
• Study Start: 2021-04-15
• Study First Submitted QC: 2021-04-20
• Study First Posted: 2021-04-22
• Primary Completion: 2022-05-30
• Study Completion: 2022-05-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-02
• Last Update Posted: 2024-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
whole body vibration	whole body vibration	the subjects will receive whole-body vibration three times per week for twelve weeks +supplementations
whole body vibration	supplementation	the subjects will receive whole-body vibration three times per week for twelve weeks +supplementations
supplementations	supplementation	the subjects will receive supplementations three times per week for twelve weeks
aerobic exercise	supplementation	the subjects will receive aerobic exercise three times per week for twelve weeks+supplementations
aerobic exercise	aerobic exercise	the subjects will receive aerobic exercise three times per week for twelve weeks+supplementations

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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

Trial Locations

Locations (1)

Al Shaymaa Shaaban Abd El Azeim; 🇪🇬 Giza, Egypt