NCT06876493

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 14, 2025

Completed
Last Updated

March 14, 2025

Status Verified

August 1, 2024

Enrollment Period

3 months

First QC Date

February 28, 2025

Last Update Submit

March 12, 2025

Conditions

Keywords

Whole Body VibrationExercisePremanstrual Syndrome

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    baseline-8 week

Study Arms (2)

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

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.

Other: Whole Body Vibration Training Programme

Interventions

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,

Aerobic Exercise 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

Whole Body Vibration Training Programme

Eligibility Criteria

Age18 Years - 32 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswoman
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Derya Azim

Bandırma, Balıkesir, 34900, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

February 28, 2025

First Posted

March 14, 2025

Study Start

February 1, 2024

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

March 14, 2025

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

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

Locations