- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06876493
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
34
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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
|
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.
|
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
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
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)
February 1, 2024
Primary Completion (Actual)
May 1, 2024
Study Completion (Actual)
May 1, 2024
Study Registration Dates
First Submitted
February 28, 2025
First Submitted That Met QC Criteria
March 12, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 12, 2025
Last Verified
August 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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
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