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

NCT04618172 | Completed DMC

• 1 other identifier: DRKZ01
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

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.

Conditions

Premenstrual Syndrome; Dysmenorrhoea

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Change of body-mind awareness

  Change of from baseline body-mind awareness results at the end of the first and second cycle

• Adherence

  up to 2 menstrual cycle

Study Arms (2)

Exercising group

EXPERIMENTAL

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

Other: Exercise

Control group

NO INTERVENTION

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

Interventions

Exercise OTHER

30 minute long exercises twice a week

Exercising group

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Kovács Zoltán: lead

Study Sites (1)

Róbert Kórház

Budapest, 1139, Hungary

Location

Related Publications (1)

• 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.

  PMID: 38002635 DERIVED

MeSH Terms

Conditions

Premenstrual Syndrome; Dysmenorrhea

Interventions

Exercise

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Henrik Szőke Dr, PhD

  University of Pecs

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: November 5, 2020
• Study Start: March 1, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)