Effects of Exercise on the Symptoms of Premenstrual Syndrome and Dysmenorrhoea and Blood Flow of Genital Tract
Primary Purpose
Premenstrual Syndrome, Dysmenorrhoea
Status
Completed
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Premenstrual Syndrome
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
- continuous use of medication (e.g. oral birth control pill or antipsychotic tablets)
- participation in other sports programs
- congenital uterine anomalies
- any chronic disease (e.g. neurological, psychological disorders, endocrinological diseases)
Sites / Locations
- Róbert Kórház
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercising group
Control group
Arm Description
This group practises 30 minute long exercises twice a week besides filling out the questionnaires.
This group fills out the questionnaires without practising 30 minute long exercises twice a week.
Outcomes
Primary Outcome Measures
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 dysmenorrhoea complaints
Rate of variation of dysmenorrhoea complaints of the participants presented in Numeric Rating Scale
Change in the genital blood flow
PI values of ultrasound flowmetry of uterine arteries presented in charts
Secondary Outcome Measures
Change of body-mind awareness
Change of body-mind awareness using The Body Awareness Questionnaire
Adherence
Measurement of adherence: frequency of visiting exercising group
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04618172
Brief Title
Effects of Exercise on the Symptoms of Premenstrual Syndrome and Dysmenorrhoea and Blood Flow of Genital Tract
Official Title
Effects of Exercise on the Symptoms of Premenstrual Syndrome and Dysmenorrhoea and Blood Flow of Genital Tract
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kovács Zoltán
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 randomized controll trial. The study has interventional and control groups. Hypothesis: The quality of life 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 exercises.
Method of the study:
2 month-long,randomized control trial, non-blind, prospective, interventional real-time comparative examination performed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome, Dysmenorrhoea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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 randomized control trial study. The study has interventional and control groups.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
113 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercising group
Arm Type
Experimental
Arm Description
This group practises 30 minute long exercises twice a week besides filling out the questionnaires.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
This group fills out the questionnaires without practising 30 minute long exercises twice a week.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
30 minute long exercises twice a week
Primary Outcome Measure Information:
Title
Change of premenstrual syndrome complaints
Description
Rate of variation of premenstrual syndrome complaints of the participants presented in PRISM (Prospective Record of the Impact and Severity of Menstrual Symptoms) questionnaire
Time Frame
Change of from baseline premenstrual syndrome complaints at next cycle
Title
Change of dysmenorrhoea complaints
Description
Rate of variation of dysmenorrhoea complaints of the participants presented in Numeric Rating Scale
Time Frame
Change of from baseline dysmenorrhoea complaints at next cycle
Title
Change in the genital blood flow
Description
PI values of ultrasound flowmetry of uterine arteries presented in charts
Time Frame
Change of from baseline art.uterina ultrasound flowmetry results after aerobic exercises and 30 minute long waiting time for control individuals
Secondary Outcome Measure Information:
Title
Change of body-mind awareness
Description
Change of body-mind awareness using The Body Awareness Questionnaire
Time Frame
Change of from baseline body-mind awareness results at the end of the first and second cycle
Title
Adherence
Description
Measurement of adherence: frequency of visiting exercising group
Time Frame
up to 2 menstrual cycle
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henrik Szőke Dr, PhD
Organizational Affiliation
University of Pecs
Official's Role
Study Chair
Facility Information:
Facility Name
Róbert Kórház
City
Budapest
ZIP/Postal Code
1139
Country
Hungary
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Exercise on the Symptoms of Premenstrual Syndrome and Dysmenorrhoea and Blood Flow of Genital Tract
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