Effect of Lifestyle Modification on Obese Females With Primary Dysmenorrhea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Pain level assessment
研究概览
简要总结
The study will be designed to determine the effect of lifestyle modification on primary dysmenorrhea in obese females.
详细描述
Menstruation in women after puberty is often confused with dysmenorrhea. Primary dysmenorrhea, where there is no apparent pelvic pathology, is characterized as painful menstrual cramps. This symptom typically occurs within one to two years of menarche and menstrual cycle stabilisation1. Pain occurs a couple of hours before or after menstruation and lasts for 12 to 72 hours. Dysmenorrhea can also be accompanied by nausea, discomfort, low back pain, or flank pain.
Obesity in women adolescents is one of the factors associated with dysmenorrhea also; Endometrium production of physiological prostaglandin increased in primary dysmenorrhea. Increased prostaglandin directly contributes to uterine contractions that eventually lead to primary dysmenorrhea. Overweight and obesity thought to be correlated with dysmenorrhea by increasing the development of prostaglandin.
The Microbiome Diet is a new, trendy weight loss diet. It created by Dr. Raphael Kellman and based on eating and avoiding certain foods in the hopes of restoring gut health. It's also claimed to offer other benefits, such as a faster metabolism and weight loss. Therefore, this study aims to investigate the effect of lifestyle modification on obese females suffering from primary dysmenorrhea
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Young females with moderate to severe primary dysmenorrhea (Visual analogue scale > 4).
- •Virgin, nonsmokers.
- •Young female aged from 18-25 years with BMI more than 30 kg/m².
- •They have regular menstrual cycles (a menstrual flow of 38 days, with 21-35 days between menstrual flows)
- •They have not practiced sports for at least one year before entering the study.
- •They have not engaged in diet for at least one year before entering the study.
排除标准
- •Any participant having Secondary dysmenorrhea (associated with identifiable pelvic pathology).
- •Any participant with a history of pelvic inflammatory disease, myoma and tumors, pelvic infection, ovarian cyst, any gynecological disease.
- •Any participant with a history of previous spinal surgeries.
- •Any participant with a history of Anemia, diabetes, hypertension, cardiovascular disease, thyroid disease, neurological disorder, rheumatoid arthritis, bariatric surgery, or taking weight loss medication.
研究组 & 干预措施
Aerobic exercise group
The participants will receive a program of aerobic exercise for 3 consecutive menstrual cycles.
干预措施: Aerobic exercise (Other)
Aerobic exercise and microbiome diet group
The participants will receive aerobic exercise in addition to microbiome diet for 3 consecutive menstrual cycles.
干预措施: Aerobic exercise (Other)
Aerobic exercise and microbiome diet group
The participants will receive aerobic exercise in addition to microbiome diet for 3 consecutive menstrual cycles.
干预措施: Microbiome diet (Other)
结局指标
主要结局
Pain level assessment
时间窗: 3 months
The visual analogue scale will be used to measure menstrual pain intensity for both groups before and after treatment.it is a valid and reliable 10 cm line ranging from 0 to 10. 0 indicates no pain,10 indicates worst pain.
Assessment of severity of dysmenorrhea
时间窗: 3 months
WaLIDD scale will be used to determine the severity of dysmenorrhea for each female in both groups by combining subjective (intensity/wong-baker, work ability) and objective (days of pain, location) manifestations for both groups. its score ranges between 0 and 3, and the final score ranges from 0 to 12 points. the higher the score, the greater the severity of dysmenorrhea.
Assessment of pain pressure threshold
时间窗: 3 months
the pressure algometer will be used to assess pain pressure threshold for all females in both groups before and after treatment on the following points: A-Two measurements 4cm from the umbilicus, bilaterally (points I and II) B-Two other measurements 4cm below the previous ones (points III and IV) C. A single measurement 4cm from the lower margin of the umbilicus (point V). D. Another single measurement into the medial side of the lumbar region below the fifth lumbar vertebra, corresponding to S2-S4 (point VI).
Body mass index
时间窗: 3 months
Weight and height measurement will be measured for each participant in both groups before and after the treatment to calculate her BMI according to the following equation: BMI (kg/m2) = Weight (kg) / Height² (m2).
Waist and hip ratio measurement:
时间窗: 3 months
Waist hip circumference were taken for each woman in both groups before and after the treatment course for calculating waist and hip ratio (WHR) by dividing the waist circumference (WC) on hip circumference (HC). By the tape measurement, (WC) was measured at the narrowest circumference between xipho-sternum and the iliac crest at the end of gentle expiration. HC was measured at the maximum circumference at the level of femoral trochanter.
次要结局
- Measurement of lumbar mobility(3 months)
- Measurement of lumbar lordotic curve(3 months)
- Assessment of Health-Related Quality of Life(3 months)
研究者
Noha Taha Abd EL-Hamed
Principal investigator
Cairo University