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临床试验/NCT04687722
NCT04687722已完成不适用

Effects of High Intensity Aerobic Training on Primary Dysmenorrhea Among Young Females.

Riphah International University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年2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
40
试验地点
2
主要终点
Numeric Pain Rating Scale (NPRS)

研究概览

简要总结

Now a days Aerobic Exercise programs has been widely used as non-pharmacological means of treating pain disorders. This study intends to determine the effects of high intensity aerobic training on pain intensity, dysmenorrhea symptoms and quality of life of young girls having primary dysmenorrhea.

详细描述

This study is a Randomized Control Trial, which will be conducted in Shifa Tameer-e-Millat University (Department of Rehabilitation Sciences). the calculated Sample size is 24 individuals using Epitool with 95% Confidence Interval (CI) and power 80%. Individual will be screened out according to inclusion criteria. Individuals will be allocated randomly into two groups, 12 in High Intensity Aerobic training group and 12 in Low Intensity Aerobic Training group by sealed envelope method. High Intensity Aerobic Training will be use in experimental group. Low Intensity Aerobic Training will be used in Control group. Assessment will be done on baseline day 1 prior to the intervention and after 8 weeks of training.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

This study will be single blinded randomized control trail, participants will be unaware of treatment groups, they will be randomly allocated through sealed envelope method.

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Unmarried female students.
  • Moderate to severe dysmenorrhea during the last three periods according to the Numeric Pain Rating Scale.

排除标准

  • Presence of known chronic disease (heart disease, kidney, respiratory, asthma, diabetes, nervous disorders, blood pressure), limitation on sports/physical activities due to special medical problems.
  • Presence of any disease of reproductive system.
  • Irregular monthly cycle.
  • Use of any particular medications affecting dysmenorrhea before or during the study.

结局指标

主要结局

Numeric Pain Rating Scale (NPRS)

时间窗: Post 8 weeks

Numeric Pain Rating Scale (NPRS) will be used for measuring pain intensity of all participants by single examiner. Patient verbally select value between (0-10) on the basis of intensity of pain. (0) means No pain and (10) means maximum pain experienced at baseline.

Menstrual Symptom Questionnaire

时间窗: Post 8 weeks

Menstrual Symptom Questionnaire will be used for measuring the severity of dysmenorrhea symptoms. It consisted of 25 items questions, participants are asked to indicate degree of their symptoms experience.

次要结局

  • SF-36 questionnaire(Post 8 weeks)
  • Serum Progesteron level(Post 8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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