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

Not Applicable

Completed

• Conditions: Premenstrual Syndrome; Dysmenorrhoea
• Interventions: Other: Exercise

• Registration Number: NCT04618172
• Lead Sponsor: Kovács Zoltán

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.

Study Timeline

• Study Start: 2019-03-01
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Study First Submitted: 2020-10-19
• Study First Submitted QC: 2020-11-04
• Study First Posted: 2020-11-05
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-01
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 113

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercising group	Exercise	This group practises 30 minute long exercises twice a week besides filling out the questionnaires.

Primary Outcome Measures

Name	Time	Method
Change of dysmenorrhoea complaints	Change of from baseline dysmenorrhoea complaints at next cycle	Rate of variation of dysmenorrhoea complaints of the participants presented in Numeric Rating Scale
Change of premenstrual syndrome complaints	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 in the genital blood flow	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

Secondary Outcome Measures

Name	Time	Method
Adherence	up to 2 menstrual cycle	Measurement of adherence: frequency of visiting exercising group
Change of body-mind awareness	Change of from baseline body-mind awareness results at the end of the first and second cycle	Change of body-mind awareness using The Body Awareness Questionnaire

Trial Locations

Locations (1)

Róbert Kórház; 🇭🇺 Budapest, Hungary