有氧运动与易筋经对年轻超重/肥胖多囊卵巢综合征患者卵巢功能影响的比较效果：一项随机对照试验的研究方案。
Comparative effectiveness of aerobic exercise versus Yi Jin Jing on ovarian function in young overweight/obese women with polycystic ovary syndrome: study protocol for a randomized controlled trial.
机构信息
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, 110 Ganhe Road, Shanghai, 200437, China.
Key Laboratory of Exercise and Health Sciences of Ministry of Education, Shanghai University of Sport, 188 Hengren Road, Shanghai, 200438, China.
出版信息
Trials. 2022 Jun 3;23(1):459. doi: 10.1186/s13063-022-06377-8.
BACKGROUND
Polycystic ovary syndrome (PCOS) is the most common heterogeneous endocrine disease among women of childbearing age, characterized by androgen excess and ovarian dysfunction. Aerobic exercise is an important solution used to manage PCOS, due to its multiple benefits. Yi Jin Jing is an important component of traditional Chinese exercise (TCE), based on the root of traditional Chinese medicine theory (TCM), which focuses on keeping the body as a whole in a harmonious state. However, to date there is no literature on the benign effects of Yi Jin Jing on PCOS. The primary purpose of this protocol is to assess the effectiveness of aerobic exercise versus Yi Jin Jing, on the management of ovarian function in young overweight/obese women with PCOS.
METHODS
The study will conduct a controlled randomized, superiority trial with three-arm parallel groups, recruiting 90 women diagnosed with PCOS, ages between 18 and 35 years, with a body mass index (BMI) ≥ 23 kg/m. Women will be randomly assigned to either control group (combined oral contraceptives) or one of the intervention groups (Yi Jin Jing group or aerobic exercise group) with an allocation rate of 1:1:1. After randomization, the intervention will be conducted within a 12-week period. The primary outcome would be anti-Mullerian hormone (AMH) level; the secondary outcomes would be biochemical profiles, ovarian volume, antral follicle count, BMI, menstrual frequency, and homeostasis model assessment of insulin resistance (HOMA-IR). Outcome measures would be collected during baseline and end of treatment. Reporting of the study will follow the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement.
DISCUSSION
This proposed study will be the first randomized clinical trial to evaluate the comparative effectiveness of aerobic exercise versus Yi Jin Jing on the management of ovarian function in young overweight/obese women with PCOS. The results may provide a new evidence-based management strategy for young women with PCOS.
TRIAL REGISTRATION
Chinese Clinical Trial Registry ChiCTR1900022385 . Registered on 9 April 2019.
背景
多囊卵巢综合征（PCOS）是育龄妇女中最常见的异质性内分泌疾病，其特征是雄激素过多和卵巢功能障碍。有氧运动是管理 PCOS 的重要解决方案，因为它有多种益处。易筋经是传统中医运动（TCE）的重要组成部分，基于传统中医理论（TCM）的根基，专注于使身体整体处于和谐状态。然而，迄今为止，尚无关于易筋经对 PCOS 有益的文献。本研究方案的主要目的是评估有氧运动与易筋经对年轻超重/肥胖 PCOS 患者卵巢功能管理的效果。
方法
该研究将进行一项有对照的、随机、优效性三臂平行组试验，招募 90 名年龄在 18 至 35 岁之间、BMI≥23kg/m²的 PCOS 女性患者。将患者随机分配至对照组（复方口服避孕药）或干预组（易筋经组或有氧运动组），分配率为 1:1:1。随机分组后，干预将在 12 周内进行。主要结局指标将是抗苗勒氏管激素（AMH）水平；次要结局指标将是生化谱、卵巢体积、窦卵泡计数、BMI、月经频率和胰岛素抵抗稳态模型评估（HOMA-IR）。在基线和治疗结束时采集结局指标。本研究将按照标准方案项目：干预试验推荐（SPIRIT）声明进行报告。
讨论
本研究将是首个评估有氧运动与易筋经对年轻超重/肥胖 PCOS 患者卵巢功能管理的比较效果的随机临床试验。研究结果可能为 PCOS 年轻女性提供新的循证管理策略。
试验注册
中国临床试验注册中心 ChiCTR1900022385 。注册于 2019 年 4 月 9 日。
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