Clinical trial NCT04618172: Effects of Exercise on the Symptoms of Premenstrual Syndrome and Dysmenorrhoea and Blood Flow of Genital Tract
Official title: Effects of Exercise on the Symptoms of Premenstrual Syndrome and Dysmenorrhoea and Blood Flow of Genital Tract
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premenstrual Syndrome
Dysmenorrhoea
Lead sponsor: University of Pecs
Sponsor class: OTHER
First posted: 2020-11-05
Enrollment: 113
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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:

1. PRISM calendar: Prospective Record of the Impact and Severity of Menstrual Symptoms (Reid, 1995). The participants have to fill out this every day,
2. 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
3. Examination to measure the intensity of menstrual pain: Numeric Rating Scale
4. Heart rate monitoring and documentation before and after the exercises; completion of the Borg Scale of Perceived Exertion to measure exercise intensity;
5. Questionnaire of life style
6. 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change of premenstrual syndrome complaints
timeFrame: Change of from baseline premenstrual syndrome complaints at next cycle
measure: Change of dysmenorrhoea complaints
timeFrame: Change of from baseline dysmenorrhoea complaints at next cycle
measure: Change in the genital blood flow
timeFrame: Change of from baseline art.uterina ultrasound flowmetry results after aerobic exercises and 30 minute long waiting time for control individuals
Secondary outcomes:
measure: Change of body-mind awareness
timeFrame: Change of from baseline body-mind awareness results at the end of the first and second cycle
measure: Adherence
timeFrame: up to 2 menstrual cycle
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Róbert Kórház
Study officials:
affiliation: University of Pecs
name: Henrik Szőke Dr, PhD
role: STUDY_CHAIR
References: