Effects of Exercise on the Symptoms of Premenstrual Syndrome and Dysmenorrhoea and Blood Flow of Genital Tract

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Exercise on the Symptoms of Premenstrual Syndrome and Dysmenorrhoea and Blood Flow of Genital Tract

Conditions
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Premenstrual Syndrome, Dysmenorrhoea

Intervention / Treatment
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* Other: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercising group<br>This group practises 30 minute long exercises twice a week besides filling out the questionnaires. | Other: Exercise<br>* 30 minute long exercises twice a week<br>|
| No Intervention: Control group<br>This group fills out the questionnaires without practising 30 minute long exercises twice a week. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | Change of from baseline art.uterina ultrasound flowmetry results after aerobic exercises and 30 minute long waiting time for control individuals | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of body-mind awareness | Change of body-mind awareness using The Body Awareness Questionnaire | 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 | up to 2 menstrual cycle |