Effect of Aerobic Exercise on Diurnal Cortisol Pattern in Premenstrual Syndrome: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Diurnal cortisol pattern
研究概览
简要总结
The aim of this study will be to investigate the effect of aerobic exercise on diurnal cortisol pattern in premenstrual syndrome.
详细描述
Premenstrual syndrome is manifested by recurrent emotional and depressive symptoms that may be associated with maladaptive coping with stress situations and the enhanced release of stress hormones, like cortisol hormone. Although previous studies revealed a flattened diurnal cortisol slope in women with PMS compared to healthy controls, there is no previous work on the effect of aerobic exercise on diurnal cortisol pattern in premenstrual syndrome. Therefore, this study will aim to investigate the effect of aerobic exercise participation on diurnal cortisol pattern in premenstrual syndrome.This trial will include two groups; group (A) will consist of 14 females who will receive relaxation training for 8 weeks, while group (B) will consist of 14 females who will receive the same relaxation training along with aerobic exercise for 8 weeks.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Random generator
入排标准
- 年龄范围
- 18 Years 至 23 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Sedentary, virginal, adult, non-smoker females suffering from premenstrual syndrome.
- •They should have regular menstrual cycles (cycles of 21-35 days with a bleeding time of 3-10 days)
- •They should have the following criteria in daily record of severity of problems in at least one of two consecutive menstrual cycles prior to treatment starting to confirm premenstrual syndrome diagnosis: a) more than three items have an average score over 3 during the luteal phase, and b) a luteal phase score is 30% more than a follicular phase score.
- •No traumatic life events in the last 2 months before starting the study.
- •Their age will be 18-23 years
- •Their body mass index (BMI) will be less than 30 kg/m2.
排除标准
- •Menstrual problems (e.g. menorrhagia, metrorhagia and polycystic ovary disease).
- •Cardio-respiratory, renal, neurological and pelvic inflammatory diseases, tumors, infections, anemia, diabetes, hypertension, asthma, rheumatoid arthritis, headache, migraine, thyroid or mental disorders.
- •Participation at any other exercise training program during this study.
- •Receiving any kind of medications, hormonal treatment or supplementation (vitamin, mineral or herbal supplement).
结局指标
主要结局
Diurnal cortisol pattern
时间窗: 8 weeks
It will be evaluated through calculating the ratio of morning cortisol level to evening cortisol level for all participants at baseline and after 8 weeks of treatment.
Severity of premenstrual symptoms
时间窗: 8 weeks
Severity of premenstrual symptoms of all participants will be measured through daily record of severity of problems (DRSP) at baseline and after 8 weeks of treatment.
次要结局
未报告次要终点
研究者
Doaa A. Osman
Assistant Professor
Cairo University