ExerciseNCT06876493
Comparison of the Effects of Whole Body Vibration Training and Aerobic Exercise on Premanstrual Syndrome
A study testing Aerobic Exercise Programme and Whole Body Vibration Training Programme in people with Exercise and Whole Body Vibration, run by Bandırma Onyedi Eylül University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 32 years, women only
- Conditions the study is for
- Exercise, Whole Body Vibration
- What is being tested?
- Aerobic Exercise Programme and Whole Body Vibration Training Programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 32 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Exercise, Whole Body Vibration
- Being tested
- Aerobic Exercise Programme, Whole Body Vibration Training Programme
- Keywords
- Whole Body Vibration, Exercise, Premanstrual Syndrome
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Exercise ProgrammeOther
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,
Whole Body Vibration Training ProgrammeOther
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
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise Programme | Experimental | 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 Receives: Other: Aerobic Exercise Programme |
| Whole Body Vibration Training Programme | Experimental | 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. Receives: Other: Whole Body Vibration Training Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premenstrual Syndrome Scale (PMSS)
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
Measured: baseline-8 week
Visual Analogue Scale (VAS)
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
Measured: baseline-8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start1 Feb 2024
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bandırma Onyedi Eylül University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derya Azim, Bandırma Onyedi Eylül University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06876493
- Sponsor's protocol ID
- 2023-242
- Status last verified
- Aug 2024
- First submitted
- 28 Feb 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study are available from the corresponding author, upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06876493
- Acronym / sponsor ID
- 2023-242
- Conditions
- Exercise, Whole Body Vibration
- Keywords
- Whole Body Vibration, Exercise, Premanstrual Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Bandırma Onyedi Eylül UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise Programme | Experimental | Other: Aerobic Exercise ProgrammeThe 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 |
| Whole Body Vibration Training Programme | Experimental | Other: Whole Body Vibration Training ProgrammeThe 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. |
Who may qualify
- Ages
- 18 to 32 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic Exercise ProgrammeThe 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 |
| Whole Body Vibration Training ProgrammeThe 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 | Other | Whole Body Vibration Training Programme |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Individual participant dataSharing planned: No. The data that support the findings of this study are available from the corresponding author, upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise Programme and Whole Body Vibration Training Programme in people with Exercise and Whole Body Vibration, run by Bandırma Onyedi Eylül University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Premenstrual Syndrome Scale (PMSS) (time frame: baseline-8 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.