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.

Study Overview

• Status: Completed
• Conditions: Premenstrual Syndrome; Dysmenorrhoea
• Intervention / Treatment: Other: 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 Type: Interventional
• Enrollment (Actual): 113
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1139
    • Róbert Kórház

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercising group; This group practises 30 minute long exercises twice a week besides filling out the questionnaires.	Other: Exercise; 30 minute long exercises twice a week
No Intervention: Control group; This group fills out the questionnaires without practising 30 minute long exercises twice a week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kovács Zoltán
• Investigators: Study Chair: Henrik Szőke Dr, PhD, University of Pecs

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: October 19, 2020
• First Submitted That Met QC Criteria: November 4, 2020
• First Posted (Actual): November 5, 2020

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease; Menstruation Disturbances; Pelvic Pain; Syndrome; Dysmenorrhea; Premenstrual Syndrome
• Other Study ID Numbers: DRKZ01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No