Comparison of the Effects of Whole Body Vibration Training and Aerobic Exercise on Premanstrual Syndrome

March 12, 2025 updated by: Derya Azim, Bandırma Onyedi Eylül University

Comparison of the Effects of Whole Body Vibration Training and Aerobic Exercise on Premanstrual Syndrome in Young Women on a Routine Dietary Intake: a Randomised Controlled Trial

Aim: The aim of the study was to compare the effects of whole body vibration training (WBVT) and aerobic exercise on premenstrual syndrome in young women with routine dietary intake.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Methods: A prospective, randomised, pre-post-test, single-blind, controlled study was conducted in 34 women diagnosed with PMS. Participants were randomly assigned into three groups: the Aerobic Exercise Group (AEG, n=11), the Whole-Body Vibration Training Group (WBVT, n=11), and the Control Group (CG, n=12). Participants in the AEG performed 45-minute exercise sessions (10 minutes warm-up, 30 minutes walk, 5 minutes cool down) three times a week for eight weeks. The WBV program was conducted using a 25 Hz frequency and a 2 mm low amplitude on the Power Plate® (pro5TM) machine, which provides three-plane oscillatory motion. The program lasted eight weeks, with sessions held three days a week, ensuring at least one rest day between sessions. The control group was asked to continue their daily life routines. Dietary intake of all participants was monitored, and those with different diets were excluded from the study. Premenstrual Syndrome Questionnaire (PMSS) was used to evaluate PMS symptoms and Visual Analogue Scale (VAS) was used to evaluate pain.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Balikesir
      • Bandirma, Balikesir, Turkey, 34900
        • Derya Azim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • BMI between 18.5-25
  • Score over 110 points on the PMS questionnaire
  • To be between the ages of 18-35
  • Sedentary women
  • Having a regular menstrual cycle (24-35 days)

Exclusion Criteria:

  • Diagnosed with eating disorder
  • Taking nutritional supplements before the last three cycles
  • DM, thyroid and liver kidney disorders
  • Endocrine drug use
  • Has undergone orthopedic surgery within the last 6 months
  • With a neurological diagnosis
  • With limited range of motion
  • Diagnosed with cardiovascular and cardiopulmonary system disorders
  • Diagnosed with women's health and diseases such as polycystic ovary syndrome, endometriosis
  • Oral contraceptive users
  • Psychiatric diagnosis
  • Smoking
  • Diagnosed with Amenorrhea
  • Following a regular diet
  • During pregnancy and lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Aerobic Exercise Programme
The aerobic exercise programme was shown to female students with premenstrual syndrome on the first day by the researcher (D.A.) at the sports centre. Participants were advised to drink water and wear running shoes during exercise. Warm-up exercises were performed for 10 minutes before the exercise. Exercise intensity was determined by the Karvonen formula (HRmax=220-age, HRR=HRmax-HR rest, 60% THR=(0.60xHRR)+HR rest). According to the pulse rate of the exercise, pulse values are monitored on the treadmill and km/hour speeds are adjusted according to pulse values. The exercise programme started with low aerobic exercise intensity on the treadmill, gradually increased at 5-minute intervals and completed at 40-60% of the heart rate, and finally 5 minutes of light stretching movements were performed to return to the initial state. In the following sessions, the participants performed the exercise programmes individually at the sports centre for 45 minutes (10 min warm-up, 30 min walk
Other: Aerobic Exercise Programme
The aerobic exercise programme was shown to female students with premenstrual syndrome on the first day by the researcher (D.A.) at the sports centre. Participants were advised to drink water and wear running shoes during exercise. Warm-up exercises were performed for 10 minutes before the exercise. Exercise intensity was determined by the Karvonen formula (HRmax=220-age, HRR=HRmax-HR rest, 60% THR=(0.60xHRR)+HR rest). .According to the pulse rate of the exercise, pulse values are monitored on the treadmill and km/hour speeds are adjusted according to pulse values. The exercise programme started with low aerobic exercise intensity on the treadmill, gradually increased at 5-minute intervals and completed at 40-60% of the heart rate, and finally 5 minutes of light stretching movements were performed to return to the initial state. In the following sessions, the participants performed the exercise programmes individually at the sports centre for 45 minutes (10 min warm-up, 30 min walk,
Experimental: Whole Body Vibration Training Programme
The WBV programme used a frequency of 25 Hz and an amplitude of 2 mm (low amplitude). The Power Plate® (pro5TM) machine provided the device's vibration. This device provides a three-plane oscillatory motion. The programme lasted eight weeks and was performed three days a week. There was at least one day's rest between each session. Before and after each vibration, stretching exercises (warm-up and cool-down programme) were performed for 5 minutes, particularly for the quadriceps and trunk extensors. The participants exercised in three different positions on the vibration platform: 1. Squat position: The knee angle was set at 120° to reduce the transmission of vibrations to the upper body (spine and head) and to increase the load on the leg muscles. 2. Bridge position: Participants stood statically in the bridge position with the soles of both feet on the platform. 3. Push-up position: Participants stood statically in the push-up position with both hands on the platform.
Other: Whole Body Vibration Training Programme
The WBV programme used a frequency of 25 Hz and an amplitude of 2 mm (low amplitude). The Power Plate® (pro5TM) machine provided the device's vibration. This device provides a three-plane oscillatory motion. The programme lasted eight weeks and was performed three days a week. There was at least one day's rest between each session. Before and after each vibration, stretching exercises (warm-up and cool-down programme) were performed for 5 minutes, particularly for the quadriceps and trunk extensors

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Premenstrual Syndrome Scale (PMSS)
Time Frame: baseline-8 week
The scale, which was developed and a validity and reliability study was carried out by Gençdoğan to measure premenstrual symptoms and determine their severity, consists of 44 items in 5-point Likert type. PMSS total score' is obtained by summing the scores obtained from these sub-dimensions. The lowest score that can be obtained from the scale is 44 and the highest score is 220. A high score indicates that the intensity of PMS symptoms is high. When the results of the PMSS are evaluated, it is decided whether PMS is present or absent according to whether the total and subscale scores exceed 50% of the highest score that can be obtained
baseline-8 week
Visual Analogue Scale (VAS)
Time Frame: baseline-8 week
In all groups, the pain intensity of the patients will be graded between 0 (no pain) and 10 (unbearable pain) using VAS. VAS is a very common scale used for pain assessment in daily practice and pain averages ranging from 0 to 10 are given in this assessment. Accordingly, '0' indicates the absence of pain, while a mean VAS value of 1-4 indicates mild pain, 5-6 indicates moderate pain and 7-10 indicates severe pain
baseline-8 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bandırma Onyedi Eylül University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-242

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data that support the findings of this study are available from the corresponding author, upon reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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