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Completed

NCT Number: NCT04618172

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

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.

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Key information

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Róbert Kórház

Budapest, 1139, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Exercise

Other

30 minute long exercises twice a week

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Change of body-mind awareness

    Time frame: 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

  2. Adherence

    Time frame: up to 2 menstrual cycle

    Measurement of adherence: frequency of visiting exercising group

Sponsors and collaborators

Lead sponsor

Kovács Zoltán

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 5, 2020
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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