Effect of Weight Reduction and Aerobic Exercise on Premenstrual Syndrome Symptoms in Obese Females
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- body weight
研究概览
简要总结
The purpose of this study will be investigation of the effect of weight reduction and aerobic exercises on premenstrual syndrome symptoms in obese females.
详细描述
both groups (A&B) will take their medical treatment in the form of (NSAIDs) and the study group B will under go a siet plan which will fits the participants. Diet plan extends for 12 weeks in the form of caloric restriction program and each woman in group B will perform aerobic exercise program, in the form of treadmill 3 times/week for 8 weeks for 12 weeks. Each session will take about 30 minutes as the following: 5 minutes warming up exercises by walking on the treadmill by low speed, 20 minutes walking at moderate intensity (70% of the maximal heart rate) and 5 minutes are cooling down by walking on the treadmill by low speed as in warming up.
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
- None
入排标准
- 年龄范围
- 20 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age will range between 20- 30 years old.
- •only females will participate in the study.
- •All patients who will be enrolled to the study will have their informed consent.
排除标准
- •Diabetes mellitus.
- •Individuals with cardiopulmonary conditions.
- •Individuals with any pelvic disease.
- •Individuals undergoing radiation therapy or chemotherapy.
- •Hepatic or pancreatic diseases.
研究组 & 干预措施
control group (A)
Group A: (control group): 20 participants Medical treatment in the form of nonsteroidal anti-inflammatory drugs (NSAIDs)
干预措施: Medical treatment. (Drug)
study group (B)
Group B: (Study group): 20 participants
- Medical treatment in the form of nonsteroidal anti-inflammatory drugs (NSAIDs).
- Physical therapy program weight reduction by diet program in the form of caloric restriction, in combination to aerobic exercise in the form of using treadmill 30 minutes /3 times a week for 12 weeks.
干预措施: Medical treatment. (Drug)
study group (B)
Group B: (Study group): 20 participants
- Medical treatment in the form of nonsteroidal anti-inflammatory drugs (NSAIDs).
- Physical therapy program weight reduction by diet program in the form of caloric restriction, in combination to aerobic exercise in the form of using treadmill 30 minutes /3 times a week for 12 weeks.
干预措施: weight reduction (Behavioral)
study group (B)
Group B: (Study group): 20 participants
- Medical treatment in the form of nonsteroidal anti-inflammatory drugs (NSAIDs).
- Physical therapy program weight reduction by diet program in the form of caloric restriction, in combination to aerobic exercise in the form of using treadmill 30 minutes /3 times a week for 12 weeks.
干预措施: exercise (Other)
结局指标
主要结局
body weight
时间窗: 12 weeks
Weight and height measurement will be measured while the woman is wearing a thin layer of clothes to calculate the BMI according to the following equation for both groups (A\&B): BMI = weight/height2 (kg/m2).
Waist and hip circumference measurements
时间窗: 12 weeks
Waist circumference was measured at the narrowest point between xipho-sternum and the iliac crest at the end of a gentle expiration; hip circumference was measured at the maximum circumference at the level of femoral trochanter. Then, waist/hip ratio was calculated by dividing waist circumference on hip circumference. All measurements were taken for all patients in both groups (A\&B), while the patient was in the standing position, before starting and after the end of the treatment course.
Progesterone levels in blood
时间窗: 12 weeks
progesterone level will be checked six to eight days after ovulation start (about day 21st of a 28-day cycle)
Premenstrual syndrome score
时间窗: 12 weeks
The premenstrual syndrome scale comprised 40 questions with three sub-scales (Physiological, Psychological and Behavioural symptoms). This 5-point Likert- type scale consisting of 40 items. The measurements on the scale are set according to the following scoring system: the response Never was scored as "1", rarely as "2", sometimes as "3", very often as "4" and always as "5" points, the total score obtained from the sub-scales established the "PMSS total score." The scale's lowest score is 40 and highest score is 200. If the scale's total score reached 80 points or above, this indicates the occurrence of PMS. Increases in the scores indicate an increase in PMS severity.
cortisol levels in blood
时间窗: 12 weeks
All women in both groups (A\&B) will be evaluated before and after the treatment (12 weeks) to show serum cortisol level. A blood sample was taken from each female in both groups (A \& B) before and after the treatment to measure the serum cortisol levels, which could reflect anxiety and pain intensity with decreased cortisol levels indicating decreased pain intensity. The cortisol level was assessed 5 days before the first day of the menstrual cycle preceding the treatment program and 5 days before the first day of the menstrual cycle at the end of treatment program,Blood sample of about 5 cm was drawn from the anticubital vein from all participants by disposable sterile syringe by vein puncture to determine plasma cortisol level. All blood samples were taken at 8-9 am and the norm cortisol level at 9 A.M ranges from 4.3-22.4 ug/dl.
次要结局
未报告次要终点
研究者
Yara Mostafa Soliman Mahmoud Abdlbary
M.SC physical therapy
Cairo University