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临床试验/NCT04618172
NCT04618172已完成不适用

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

Kovács Zoltán2 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
113
试验地点
2
主要终点
Change of dysmenorrhoea complaints

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Change of dysmenorrhoea complaints

时间窗: Change of from baseline dysmenorrhoea complaints at next cycle

Rate of variation of dysmenorrhoea complaints of the participants presented in Numeric Rating Scale

Change in the genital blood flow

时间窗: 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

Change of premenstrual syndrome complaints

时间窗: 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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kovács Zoltán

Principal Investigator

University of Pecs

研究点 (2)

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