Premenstrual SyndromePMSNCT04855981
Whole-body Vibration Versus Aerobic Exercise on the Inflammatory Status and Hormonal Parameters Premenstrual Syndrome
A study testing whole body vibration, aerobic exercise and supplementation in people with Premenstrual Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women only
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- whole body vibration, aerobic exercise and supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2021to 30 May 2022
- 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 25 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females suffering from PMS (as determined by PMS scale).
- Their ages will range from 18 to 25 years.
- Having regular menstrual cycle.
Who cannot join
- Smoking.
- Taking any medications.
- History of chronic disease.
- Having any psychiatric or gynecological problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Whole-body Vibration Versus Aerobic Exercise on the Inflammatory Status and Hormonal Parameters in Females With 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.
Read the detailed description
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
- Conditions
- Premenstrual Syndrome
- Being tested
- whole body vibration, aerobic exercise, supplementation
- Keywords
- whole body vibration, aerobic exercises, premenstrual syndrome
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole body vibrationOther
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 exerciseOther
the subjects will receive aerobic exercises+ magnesium (Mg) (250 g) and vitamin B6 supplementation
supplementationOther
the subjects will receive magnesium (Mg) (250 g) and vitamin B6 supplementation
| Study group | Role | What they receive |
|---|---|---|
| whole body vibration | Experimental | the subjects will receive whole-body vibration three times per week for twelve weeks +supplementations Receives: Other: whole body vibration; Other: supplementation |
| aerobic exercise | Experimental | the subjects will receive aerobic exercise three times per week for twelve weeks+supplementations Receives: Other: aerobic exercise; Other: supplementation |
| supplementations | Active comparator | the subjects will receive supplementations three times per week for twelve weeks Receives: Other: supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
premenstrual symptoms
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
Measured: up to twelve weeks
Secondary outcomes (3)
CRP level assessment
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.
Measured: up to twelve weeks
cortisol level
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.
Measured: up to twelve weeks
hormonal analysis
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
Measured: up to twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start15 Apr 2021
- Primary completion30 May 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Model description
- whole-body vibration and aerobic exercise
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Al Shaymaa Shaaban Abd El Azeim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04855981
- Sponsor's protocol ID
- p.t.REC/012/003183
- Acronym
- PMS
- Status last verified
- Feb 2024
- First submitted
- 7 Apr 2021
- Last updated
- 5 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Whole-body Vibration Versus Aerobic Exercise on the Inflammatory Status and Hormonal Parameters in Females With Premenstrual Syndrome
- ClinicalTrials.gov ID
- NCT04855981
- Acronym / sponsor ID
- PMS / p.t.REC/012/003183
- Conditions
- Premenstrual Syndrome
- Keywords
- whole body vibration, aerobic exercises, premenstrual syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 22 Apr 2021 (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.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- whole-body vibration and aerobic exercise
| Arm | Type | Receives |
|---|---|---|
| whole body vibration | Experimental | Other: whole body vibration, Other: supplementationthe subjects will receive whole-body vibration three times per week for twelve weeks +supplementations |
| aerobic exercise | Experimental | Other: aerobic exercise, Other: supplementationthe subjects will receive aerobic exercise three times per week for twelve weeks+supplementations |
| supplementations | Active comparator | Other: supplementationthe subjects will receive supplementations three times per week for twelve weeks |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Females suffering from PMS (as determined by PMS scale).
- Their ages will range from 18 to 25 years.
- Having regular menstrual cycle.
Key exclusion criteria (4 listed)
- Smoking.
- Taking any medications.
- History of chronic disease.
- Having any psychiatric or gynecological problems
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 |
|---|---|---|
| whole body vibrationAll 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 | Other | whole body vibration |
| aerobic exercisethe subjects will receive aerobic exercises+ magnesium (Mg) (250 g) and vitamin B6 supplementation | Other | aerobic exercise |
| supplementationthe subjects will receive magnesium (Mg) (250 g) and vitamin B6 supplementation | Other | aerobic exercise, supplementations, whole body vibration |
Primary outcome
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
3 secondary outcomes
CRP level assessment
Time frame: up to twelve weeks
cortisol level
Time frame: up to twelve weeks
hormonal analysis
Time frame: up to twelve weeks
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 5 Feb 2024.
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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 whole body vibration, aerobic exercise and supplementation in people with Premenstrual Syndrome, run by Cairo University at 1 site in Egypt.
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 3 inclusion and 4 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 5 Feb 2024. 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 Egypt. 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 symptoms (time frame: up to twelve weeks). 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 5 Feb 2024.