Effect of Exercise adherence strategies on the Outcomes of Home-based exercise program for Polycystic Ovary Syndrome: Randomized Controlled Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Exercise adherence calendar
研究概览
简要总结
Polycystic ovary syndrome (PCOS) is a common endocrine condition that affects many women and presents with a range of symptoms and consequences. Lifestyle modification is emphasized as the main early therapeutic strategy in the management of PCOS as mentioned in “The International Evidence-Based Guideline for the assessment and management of PCOS†published in the year 2023. Though lifestyle management reportedly has many benefits and is a cost-effective method, the adherence to lifestyle management (exercise and diet) is found to be low in both diseased and non-diseased population. So, this study is focusing on impact of exercise adherence strategies to improve the adherence levels (i.e. overcoming barriers) and facilitate adherence to exercise interventions in women with PCOS. This study identifies and tests the possible strategies to combat barriers to exercise participation and adherence. Patients referred to OBG physiotherapy department from obstetrics and gynaecology department of SDM college of medical sciences and hospital, Dharwad and Alternately those directly consulting the OBG physiotherapy department, SDM college of medical sciences and hospital, Dharwad will be screened for inclusion and exclusion criteria. Patients who fulfil the criteria will be provided with the requisite details about the study procedure. Patients who are willing to participate and have given consent for the same will be recruited for the study. The participants signed consent will be obtained and a copy of the information sheet will be shared. Study procedure will be explained to the participants. The details of the participants will be documented. Randomization and allocation will be done using SNOSE method and participants will be assigned to experimental and control group accordingly. The assessment of the participants will be done and findings will be recorded. The participants will be given intervention and called for follow up for every 15 days for a period of three months and re-assessment and progression to exercises will be done and their compliance calendar will be checked and number of sessions completed will be recorded. Required support will be provided to continue the programme. After 3 months post intervention assessment will be done and findings will be recorded. Data so collected will be analysed statistically.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women diagnosed with PCOS by a certified medical practitioner
- •Age of participants: 18 years to 35 years
- •Participants who are willing to give written informed consent.
排除标准
- •Participants with any other medical condition which contradicts them from participating in physical activity.
- •Participants who are pregnant
- •Participants undergoing IVF treatment
- •Psychiatric disorder
- •Uncooperative participants
- •Participants who are not willing to participate.
结局指标
主要结局
Exercise adherence calendar
时间窗: Exercise adherence calendar will be given to the participants to regularly fill it (everyday for 3 months) which will be collected back at the end of the | study.
次要结局
- Regularity of menstrual cycle(It will be taken during the initial assessment and after 3 months (post intervention).)
- The Modified Ferriman-Gallwey (Mfg) Score(It will be taken during the initial assessment and after 3 months (post intervention).)
- KARADA scan(It will be taken during the initial assessment and after 3 months (post intervention).)
- Waist hip ratio(It will be taken during the initial assessment and after 3 months (post intervention).)
- Blood reports - FSH, LH, Prolactin, Testosterone, TSH, Glucose fasting, Glucose post prandial(It will be taken during the initial assessment and after 3 months (post intervention).)
研究者
Chaithra R
SDM College of Physiotherapy