Combine Effects of Senobi Exercise & Aerobic Exercises on Body Mass Index, Fatigue and Quality of Life in Polycystic Ovarian Syndrome.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- WHQOL-BREF Questionnaire
研究概览
简要总结
One of the most prevalent endocrine system conditions affecting women of reproductive age is polycystic ovary syndrome (PCOS), also known as hyperandrogenic anovulation (HA) or Stein-Leventhal syndrome. This chronic and heterogeneous disorder manifests itself as menstrual dysfunction, infertility, hirsutism, acne, and obesity. This study will be randomized controlled trial and will be conducted in Qasim Sandhu medical complex, Iiffat Anwar Medical Complex and OMC Hospital Lahore. Data will be collected 10 months after approval of synopsis. The total duration of treatment will be 6 weeks. Non-probability convenience sampling technique will be used and 32 participants will be recruited in study after randomization according to selection criteria. The subjects will be divided into two groups, 16 participants in each group. Group A (experimental group) will receive senobi exercises and aerobic exercises, 3 days\week for 6 weeks and Group B (control group) will receive aerobic exercises, 3days\week for 6 week.
详细描述
One of the most prevalent endocrine system conditions affecting women of reproductive age is polycystic ovary syndrome (PCOS), also known as hyperandrogenic anovulation (HA) or Stein-Leventhal syndrome. This chronic and heterogeneous disorder manifests itself as menstrual dysfunction, infertility, hirsutism, acne, and obesity. It is usually only diagnosed when complications develop that significantly reduce a patient's quality of life (e.g., hair loss, alopecia, acne, and infertility-related problems). The World Health Organization (WHO) estimates that in 2012 PCOS affected 116 million women globally. Although PCOS can occur at any age, beginning with menarche, the majority of instances are identified between the ages of 20 and 30. Polycystic ovary syndrome (PCOS) is an important and highly prevalent obesity-related comorbidity that develops in girls and women who are genetically predisposed to its development. This study will be randomized controlled trial and will be conducted in Qasim Sandhu medical complex, Iiffat Anwar Medical Complex and OMC Hospital Lahore. Data will be collected 10 months after approval of synopsis. The total duration of treatment will be 6 weeks. Non-probability convenience sampling technique will be used and 32 participants will be recruited in study after randomization according to selection criteria. The subjects will be divided into two groups, 16 participants in each group. Group A (experimental group) will receive senobi exercises and aerobic exercises, 3 days\week for 6 weeks and Group B (control group) will receive aerobic exercises, 3days\week for 6 week. Nutritional counselling and deep breath for 5 minutes will be used as Baseline treatment. The tools that will be used are BMI Calculator for obesity, WHQOL-BREF Questionnaire for Quality of life and multidimensional fatigue inventory (MFI) questionnaire to assess fatigue. After data collection data will be analyzed by using SPSS version 25.
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
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between the Ages of 18 to 35 Diagnosed with PCOS Menstrual disturbance > 3 months BMI of 29-35kg/m Unmarried and married with multiparous
排除标准
- •Women with other causes of menstrual disturbances (ovarian cancer) Known cardiovascular problems (cardiac arrhythmias) Uncontrolled hypertension or low blood pressure Presence of neurological disease (epilepsy, autism) Orthopedic illness (rheumatoid arthritis, osteoporosis) Cardiopulmonary disease (CVD, COPD) Musculoskeletal injuries (fracture, tendon rupture) Antiobesity medications
研究组 & 干预措施
Group A (experimental group)
The participants in group A will receive interventional treatment (senobi exercises), 3 days a week for 6 weeks as a supervised exercise program, as well as they will receive aerobic exercises on treadmill with 10% grade and 5mph speed for 20 minutes a session with 5 minutes of warm up and 5 minutes of cool down of total 30 minutes a session, 5 sessions for a week for 6 weeks. Baseline treatment for both groups will be deep Breathing exercise- 5 reps/3 seconds inspiration 6 seconds expiration/1 set. Self-stretching exercise for biceps and triceps- 5 reps/5 seconds hold/1 set and walking for 3 alternate days per week for 6 weeks as a home exercise program.
干预措施: Senobi exercises with aerobics exercises (Other)
Group B (control group)
The participants in group B will receive aerobic exercises on treadmill ( fig. 2) with 10% grade and 5mph speed for 20 minutes a session with 5 minutes of warm up and 5 minutes of cool down of total 30 minutes a session, 5 sessions for a week for 6 weeks. Subjects will be assessed at baseline and after 6 weeks. The post-interventional assessment will be taken and the results will be interpreted. Baseline treatment for both groups will be deep Breathing exercise- 5 reps/3 seconds inspiration 6 seconds expiration/1 set. Self-stretching exercise for biceps and triceps- 5 reps/5 seconds hold/1 set and walking for 3 alternate days per week for 6 weeks as a home exercise program.
干预措施: aerobic exercises (Other)
结局指标
主要结局
WHQOL-BREF Questionnaire
时间窗: 6 weeks
WHOQOL-BREF questionnaire is a reliable instrument to measure quality of life. QOL-BREF (WHOQOLBREF) questionnaire which captures many subjective aspects of QOL. This questionnaire is one of the best known instruments that has been developed for cross-cultural comparisons of QOL and is available in many languages. This instrument, by focusing on individuals' own views of their well-being, provides a new perspective on life. Its internal consistency is (α = 0.925).
Multidimensional fatigue inventory
时间窗: 6 weeks
The Multidimensional Fatigue Inventory (MFI-20) is a valid tool for assessment of fatigue. MFI-20 covering general fatigue, physical fatigue, mental fatigue, reduced activity and reduced motivation has been widely used in patients with chronic fatigue syndrome. The internal consistency of MFI-20 is (Cronbach's alpha = 0.89).
Body Mass Index
时间窗: 6 weeks
Body mass index (BMI), is a measurement tool based on a person's height and weight, and allows the classification of individuals into categories such as obese or overweight. Body mass index (BMI) is one of the ways to measure obesity in the population. Body mass index (BMI) can be calculated via mathematical operations where height and weight values are used to estimate the health status of a person.
次要结局
未报告次要终点
研究者
Wajeeha Zia
Assistant Professor
Riphah International University