Premenstrual SyndromeNCT04618172
Effects of Exercise on the Symptoms of Premenstrual Syndrome and Dysmenorrhoea and Blood Flow of Genital Tract
A study testing Exercise in people with Premenstrual Syndrome and Dysmenorrhoea, run by Kovács Zoltán at 1 site in Hungary.
Trial summary
Effects of exercise on the symptoms of premenstrual syndrome and dysmenorrhoea and blood flow of genital tract. Different self-reported questionnaires and vaginal ultrasound flowmetry are used in the prospective observational trial. The study has interventional and control groups. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndrome, Dysmenorrhoea
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteHungary
- Study dates
- 1 Mar 2019to 30 Jun 2020
- 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 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 17-35
- regular menstrual cycles (cycles of 21-35 days)
- no endocrinological disease
- no endometriosis
- no experience in Aviva aerob exercises
- symptoms of premenstrual syndrome
- symptoms of dysmenorrhoea
- Score below 40 from Beck depression questionnaire
Who cannot join
- pregnancy
- pelvic inflamatory disease (PID), secondary dysmenorrhoea
- gynecological operation
- failure to complete the questionnaire (3 consecutive days and 5 days interrupted)
- dissatisfaction with the continuation of the research
- the incidence of adverse life events in the last 3 months
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- use of medication (e.g. oral birth control pill,painkiller,antipsychotic tablets)
- participation in other sports programs
- congenital uterine anomalies
- any chronic disease (e.g. neurological, psychological disorders, endocrinological diseases)
Trial locations and contacts
1 site in 1 country.
About this study
Effects of exercise on the symptoms of premenstrual syndrome and dysmenorrhoea and blood flow of genital tract. Different self-reported questionnaires and vaginal ultrasound flowmetry are used in the prospective observational trial. The study has interventional and control groups. There are changes in premenstrual syndrome complaints and dysmenorrhoea complaints during the study period.The deegre of menstrual pain and self-awareness improve during the period of study. The ultrasound examination shows changes in genital blood flow after exercise.
Read the detailed description
Subject of the study:
Examination of premenstrual syndrome and dysmenorrhoea treatment results with Aviva exercise intervention.
Method of the study:
Prospective observational trial with the participation of volunteers.
Questionnaires:
- PRISM calendar: Prospective Record of the Impact and Severity of Menstrual Symptoms (Reid, 1995). The participants have to fill out this every day,
- The Body Awareness Questionnaire Shields, S. A., Mallory, M.E., \& Simon, A. (1989). The Body Awareness Questionnaire: Reliability and validity. Journal of Personality Assessment, 53(4), 802-815
- Examination to measure the intensity of menstrual pain: Numeric Rating Scale
- Heart rate monitoring and documentation before and after the exercises; completion of the Borg Scale of Perceived Exertion to measure exercise intensity;
- Questionnaire of life style
- Beck depression questionnaire
Ultrasound examination:
Doing the Aviva exercises, ultrasound measurements are performed in Robert Hospital (Budapest) on the patients participating in the study. The first measurement is performed for each person before starting the exercises. When the first subject has finished the exercise, a control ultrasound measurement will be carried out.
In the control group there is also twice ultrasound examination for the individuals.
Measured parameters: PI (pulsatility index) of uterine artery transvaginal ultrasound measurement followed by statistical evaluation of the results.
- Conditions
- Premenstrual Syndrome, Dysmenorrhoea
- Being tested
- Exercise
- Medical subject headings
- Premenstrual Syndrome, Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
30 minute long exercises twice a week
| Study group | Role | What they receive |
|---|---|---|
| Exercising group | Experimental | This group practises 30 minute long exercises twice a week besides filling out the questionnaires. Receives: Other: Exercise |
| Control group | No intervention | This group fills out the questionnaires without practising 30 minute long exercises twice a week. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of premenstrual syndrome complaints
Rate of variation of premenstrual syndrome complaints of the participants presented in PRISM (Prospective Record of the Impact and Severity of Menstrual Symptoms) questionnaire
Measured: Change of from baseline premenstrual syndrome complaints at next cycle
Change of dysmenorrhoea complaints
Rate of variation of dysmenorrhoea complaints of the participants presented in Numeric Rating Scale
Measured: Change of from baseline dysmenorrhoea complaints at next cycle
Change in the genital blood flow
PI values of ultrasound flowmetry of uterine arteries presented in charts
Measured: Change of from baseline art.uterina ultrasound flowmetry results after aerobic exercises and 30 minute long waiting time for control individuals
Secondary outcomes (2)
Change of body-mind awareness
Change of body-mind awareness using The Body Awareness Questionnaire
Measured: Change of from baseline body-mind awareness results at the end of the first and second cycle
Adherence
Measurement of adherence: frequency of visiting exercising group
Measured: up to 2 menstrual cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start1 Mar 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premenstrual SyndromeStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Effects of exercise on the symptoms of premenstrual syndrome and dysmenorrhoea and blood flow of genital tract. Different self-reported questionnaires and vaginal ultrasound flowmetry are used in the prospective observational study. The study has interventional and control groups.
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kovács Zoltán
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kovács Zoltán, University of Pecs
- Investigators
- Henrik Szőke Dr, PhD, Study chair, University of Pecs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618172
- Sponsor's protocol ID
- DRKZ01
- Status last verified
- Nov 2023
- First submitted
- 19 Oct 2020
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kovacs Z, Hegyi G, Szoke H. The Effect of Exercise on Pulsatility Index of Uterine Arteries and Pain in Primary Dysmenorrhea. J Clin Med. 2023 Nov 10;12(22):7021. doi: 10.3390/jcm12227021.
PubMed 38002635
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise on the Symptoms of Premenstrual Syndrome and Dysmenorrhoea and Blood Flow of Genital Tract
- ClinicalTrials.gov ID
- NCT04618172
- Acronym / sponsor ID
- DRKZ01
- Conditions
- Premenstrual Syndrome, Dysmenorrhoea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Kovács ZoltánUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 5 Nov 2020 (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.
Effects of exercise on the symptoms of premenstrual syndrome and dysmenorrhoea and blood flow of genital tract. Different self-reported questionnaires and vaginal ultrasound flowmetry are used in the prospective observational trial. The study has interventional and control groups. There are changes in premenstrual syndrome complaints and dysmenorrhoea complaints during the study period.The deegre of menstrual pain and self-awareness improve during the period of study. The ultrasound examination shows changes in genital blood flow after exercise.
Detailed description
Subject of the study:
Examination of premenstrual syndrome and dysmenorrhoea treatment results with Aviva exercise intervention.
Method of the study:
Prospective observational trial with the participation of volunteers.
Questionnaires:
- PRISM calendar: Prospective Record of the Impact and Severity of Menstrual Symptoms (Reid, 1995). The participants have to fill out this every day,
- The Body Awareness Questionnaire Shields, S. A., Mallory, M.E., \& Simon, A. (1989). The Body Awareness Questionnaire: Reliability and validity. Journal of Personality Assessment, 53(4), 802-815
- Examination to measure the intensity of menstrual pain: Numeric Rating Scale
- Heart rate monitoring and documentation before and after the exercises; completion of the Borg Scale of Perceived Exertion to measure exercise intensity;
- Questionnaire of life style
- Beck depression questionnaire
Ultrasound examination:
Doing the Aviva exercises, ultrasound measurements are performed in Robert Hospital (Budapest) on the patients participating in the study. The first measurement is performed for each person before starting the exercises. When the first subject has finished the exercise, a control ultrasound measurement will be carried out.
In the control group there is also twice ultrasound examination for the individuals.
Measured parameters: PI (pulsatility index) of uterine artery transvaginal ultrasound measurement followed by statistical evaluation of the results.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Effects of exercise on the symptoms of premenstrual syndrome and dysmenorrhoea and blood flow of genital tract. Different self-reported questionnaires and vaginal ultrasound flowmetry are used in the prospective observational study. The study has interventional and control groups.
| Arm | Type | Receives |
|---|---|---|
| Exercising group | Experimental | Other: ExerciseThis group practises 30 minute long exercises twice a week besides filling out the questionnaires. |
| Control group | No intervention | –This group fills out the questionnaires without practising 30 minute long exercises twice a week. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- BMI 17-35
- regular menstrual cycles (cycles of 21-35 days)
- no endocrinological disease
- no endometriosis
- no experience in Aviva aerob exercises
Key exclusion criteria (10 listed)
- pregnancy
- pelvic inflamatory disease (PID), secondary dysmenorrhoea
- gynecological operation
- failure to complete the questionnaire (3 consecutive days and 5 days interrupted)
- dissatisfaction with the continuation of the research
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 |
|---|---|---|
| Exercise30 minute long exercises twice a week | Other | Exercising group |
Primary outcome
Change of premenstrual syndrome complaints
Time frame: Change of from baseline premenstrual syndrome complaints at next cycle
Rate of variation of premenstrual syndrome complaints of the participants presented in PRISM (Prospective Record of the Impact and Severity of Menstrual Symptoms) questionnaire
Change of dysmenorrhoea complaints
Time frame: Change of from baseline dysmenorrhoea complaints at next cycle
Rate of variation of dysmenorrhoea complaints of the participants presented in Numeric Rating Scale
Change in the genital blood flow
Time frame: Change of from baseline art.uterina ultrasound flowmetry results after aerobic exercises and 30 minute long waiting time for control individuals
PI values of ultrasound flowmetry of uterine arteries presented in charts
2 secondary outcomes
Change of body-mind awareness
Time frame: Change of from baseline body-mind awareness results at the end of the first and second cycle
Adherence
Time frame: up to 2 menstrual cycle
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 7 Nov 2023.
- Derived from this study: PubMed 38002635Kovacs Z, Hegyi G, Szoke H. The Effect of Exercise on Pulsatility Index of Uterine Arteries and Pain in Primary Dysmenorrhea. J Clin Med. 2023 Nov 10;12(22):7021. doi: 10.3390/jcm12227021.
- Individual participant dataSharing planned: No
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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.
Henrik Szőke Dr, PhD study chair
University of Pecs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Premenstrual Syndrome and Dysmenorrhoea, run by Kovács Zoltán at 1 site in Hungary.
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 8 inclusion and 10 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 7 Nov 2023. 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 Hungary. 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?
Change of premenstrual syndrome complaints (time frame: Change of from baseline premenstrual syndrome complaints at next cycle). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04618172, which also lists 1 linked publication.
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 7 Nov 2023.