Comparative Effectiveness of Aerobic Exercise Versus Yi Jin Jing On Reproductive Health In Young Overweight/Obese Women With Polycystic Ovary Syndrome: Study Protocol For A Randomized Controlled Trial.

Abstract

\n Background: Polycystic ovary syndrome (PCOS) is the most common heterogeneous endocrine disease among women of childbearing age, affecting women throughout life on their reproductive, metabolic and cardiovascular health, as well as psychological health. 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 PCOS-related reproductive health in young overweight/obese women.Methods: The study will conduct a three-armed parallel-group of a randomized controlled trial, recruiting 90 women diagnosed with PCOS, ages between 18 and 35 years, with a body mass index (BMI) ≥ 23 kg/m2. 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. The intervention will be conducted within a 12-week period. The primary outcomes would be anti-Mullerian hormone (AMH) level and menstrual frequency; the secondary outcomes would be biochemical profiles, ovarian volume, antral follicle count, BMI 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 PCOS-related reproductive symptoms in young overweight/obese women. The results will provide a new evidence-based management strategy for young women with PCOS. Trial registration: Chinese Clinical Trail Registry, ID: ChiCTR1900022385. Registered on 9 April 2019, http://www.chictr.org.cn/listbycreater.aspx.