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

NCT ID: NCT04618172

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2020-06-30

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.

Conditions

Premenstrual Syndrome; Dysmenorrhoea

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercising group

This group practises 30 minute long exercises twice a week besides filling out the questionnaires.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

30 minute long exercises twice a week

Control group

This group fills out the questionnaires without practising 30 minute long exercises twice a week.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise

30 minute long exercises twice a week

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kovács Zoltán

OTHER

Sponsor Role: lead

Responsible Party

Kovács Zoltán

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Henrik Szőke Dr, PhD

Role: STUDY_CHAIR

University of Pecs

Locations

Róbert Kórház

Budapest, , Hungary

Countries

Hungary

References

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.

Reference Type: DERIVED

PMID: 38002635 (View on PubMed)

Other Identifiers

DRKZ01

Identifier Type: -

Identifier Source: org_study_id