跳至主要内容
临床试验/NCT06461585
NCT06461585招募中不适用

Effects of Sprint Interval Training Versus Arabic Exercises BMI Waist-to-hip Ratio and Quality of Life in Obese Women PCOS

Riphah International University2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年12月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
36
试验地点
2
主要终点
Modified Borg CR10 RPE scale (For Exertion level)

研究概览

简要总结

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age and is the leading cause of infertility and anovulation. According to the Rotterdam criteria, the prevalence of PCOS is estimated to affect up to 20% of the female population. PCOS is characterized by increased androgen production and decreased ovulation leading to clinical manifestations including acne, hirsutism, male pattern baldness, irregular menstrual cycles, and infertility. In addition to concerns about fertility and hyperandrogenism, PCOS is considered a metabolic disorder, with an increased risk of developing insulin resistance (IR), hyperinsulinemia, dyslipidemia, and low-grade inflammation. In addition to genetic involvement, environmental aspects such as obesity conditions. affect the progression of PCOS or even make patients' clinical conditions worse. Exercise is an important component of PCOS management, and exercises have been shown to improve metabolic and reproductive outcomes in women with PCOS. The study will be a randomized clinical trial. This study will be completed in a time duration of 7 months after the approval of the synopsis. Sample size 32 is calculated by the Epi tool.variable for the sample size is BMI. By the non-probability convenience sampling technique, participants will be divided into 2 groups. Group A the Interventional group will receive SIT and Group B will receive the aerobic exercise. Group A will perform SIT 3 times a week for 30-second sprints on a cycle ergometer with 4 minutes of rest between each sprint, complete session will be for 30 -40 minutes while Group B will perform the aerobic exercise for 30-40 minutes of moderate-intensity continuous exercise on a treadmill and stationary cycle. The outcome measure will be evaluated by using the BMI Calculator, PCOSQOL, measuring tape Borg scale. After Collecting data from the before and after treatment sessions. The data will be analyzed by using SPSS version 25.

详细描述

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age and is the leading cause of infertility and anovulation. According to the Rotterdam criteria, the prevalence of PCOS is estimated to affect up to 20% of the female population. PCOS is characterized by increased androgen production and decreased ovulation leading to clinical manifestations including acne, hirsutism, male pattern baldness, irregular menstrual cycles, and infertility. In addition to concerns about fertility and hyperandrogenism, PCOS is considered a metabolic disorder, with an increased risk of developing insulin resistance (IR), hyperinsulinemia, dyslipidemia, and low-grade inflammation. In addition to genetic involvement, environmental aspects such as obesity conditions. affect the progression of PCOS or even make patients' clinical conditions worse. Exercise is an important component of PCOS management, and exercises have been shown to improve metabolic and reproductive outcomes in women with PCOS. The study will be a randomized clinical trial. The study will be conducted in the settings of Jinnah Hospital Lahore, Shapes Gym, and UFC Gym. This study will be completed in a time duration of 7 months after the approval of the synopsis. Sample size 32 is calculated by the Epi tool.variable for the sample size is BMI. By the non-probability convenience sampling technique, participants will be divided into 2 groups. Group A the Interventional group will receive SIT and Group B will receive the aerobic exercise. Group A will perform SIT 3 times a week for 30-second sprints on a cycle ergometer with 4 minutes of rest between each sprint, complete session will be for 30 -40 minutes while Group B will perform the aerobic exercise for 30-40 minutes of moderate-intensity continuous exercise on a treadmill and stationary cycle. The outcome measure will be evaluated by using the BMI Calculator, PCOSQOL, measuring tape Borg scale. After Collecting data from the before and after treatment sessions. The data will be analyzed by using SPSS version 25.

Keywords: Body Mass Index, High-Intensity Interval Training, Polycystic Ovary Syndrome, Quality of Life

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 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Diagnosed PCOS
  • Age: 18 - 35 years.
  • BMI ≥25 kg/m2
  • Unmarried females (5)
  • Oligomenorrhea
  • Irregular cycles (Have less than 9 periods in 1 year

排除标准

  • Congenital adrenal hyperplasia, androgen-secreting tumors, and Cushing's syndrome
  • Cardiovascular diseases and thrombotic diseases.
  • Systemic illness (Acute or chronic hepatitis or nephritis, musculoskeletal and pulmonary disorder)
  • Taking medications known to affect ovarian function within the past 3 months.
  • Patients suffer from mental problems.

结局指标

主要结局

Modified Borg CR10 RPE scale (For Exertion level)

时间窗: 8 weeks

PCOSQOL

Waist-to-hip ratio: (Measuring tape)

时间窗: 8 weeks

BMI Calculator: BMI Calculator:

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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