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Completed

NCT Number: NCT04855981

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

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.

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Key information

Conditions

Premenstrual Syndrome Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Al Shaymaa Shaaban Abd El Azeim

Giza, 12511, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Aerobic Exercise

Other

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

supplementation

Other

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

Primary outcomes

  1. premenstrual symptoms

    Time frame: 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 outcomes

  1. CRP level assessment

    Time frame: 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.

  2. cortisol level

    Time frame: 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.

  3. hormonal analysis

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Acronym: PMS

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 22, 2021
Registry last updated
Feb 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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