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

Premenstrual Syndrome Clinical Trial

— PMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04855981
• Other study ID #: p.t.REC/012/003183
• Status: Completed
• Phase: N/A
• Start date: April 15, 2021
• Est. completion date: May 30, 2022

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: May 30, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Premenstrual Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Egypt	Al Shaymaa Shaaban Abd El Azeim	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to twelve weeks
Secondary	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.	up to twelve weeks
Secondary	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.	up to twelve weeks
Secondary	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	up to twelve weeks