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

NCT04855981 | Completed

• 1 other identifier: p.t.REC/012/003183
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Premenstrual Syndrome

Keywords

whole body vibration; aerobic exercises; premenstrual syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• CRP level assessment

  up to twelve weeks

• cortisol level

  up to twelve weeks

• hormonal analysis

  up to twelve weeks

Study Arms (3)

whole body vibration

EXPERIMENTAL

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

Other: whole body vibration; Other: supplementation

aerobic exercise

EXPERIMENTAL

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

Other: aerobic exercise; Other: supplementation

supplementations

ACTIVE COMPARATOR

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

Other: supplementation

Interventions

whole body vibration 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

whole body vibration

aerobic exercise OTHER

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

aerobic exercise

supplementation OTHER

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

aerobic exercise; supplementations; whole body vibration

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Females suffering from PMS (as determined by PMS scale).
• Their ages will range from 18 to 25 years.
• Having regular menstrual cycle.

You may not qualify if:

• Smoking.
• Taking any medications.
• History of chronic disease.
• Having any psychiatric or gynecological problems

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Al Shaymaa Shaaban Abd El Azeim

Giza, 12511, Egypt

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

Exercise; Dietary Supplements

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: random generator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principale investigator. al shaymaa shaaban abd el azeim

Model Details: whole-body vibration and aerobic exercise

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 22, 2021
• Study Start: April 15, 2021
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2022
• Last Updated: February 5, 2024

Record last verified: 2024-02

Locations

EG (1)