Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2022

Open Access 01-12-2022 | Polycystic Ovary Syndrome | Study protocol

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

Authors: Jing Zhao, Antonnette Ketlhoafetse, Xiangyun Liu, Yang Cao

Published in: Trials | Issue 1/2022

Login to get access

Abstract

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/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. 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 
Appendix
Available only for authorised users
Literature
1.
Azziz R, Woods KS, Reyna R, et al. The prevalence and features of the polycystic ovary syndrome in an unselected population. J Clin Endocrinol Metab. 2004;89(6):2745–9.PubMedCrossRef
2.
3.
Barber TM. Polycystic ovary syndrome: insight into pathogenesis and a common association with insulin resistance. Clin Med. 2016;16(3):262–6.CrossRef
4.
Franks S. Assessment and management of anovulatory infertility in polycystic ovary syndrome. Endocrinol Metab Clin North Am. 2003;32(3):639–51.PubMedCrossRef
5.
6.
7.
8.
Liang SJ, Hsu CS, Tzeng CR, et al. Clinical and biochemical presentation of polycystic ovary syndrome in women between the ages of 20 and 40. Hum Reprod. 2011;26(12):3443–9.PubMedCrossRef
9.
Brown ZA, Louwers YV, Fong SL, et al. The phenotype of polycystic ovary syndrome ameliorates with aging. Fertil Steril. 2011;96(5):1259–65.PubMedCrossRef
10.
Lim SS, Davies MJ, Norman RJ, et al. Overweight, obesity and central obesity in women with polycystic ovary syndrome: a systematic review and meta-analysis. Hum Reprod Update. 2012;18(6):618–37.PubMedCrossRef
11.
Lim SS, Norman RJ, Davies MJ, et al. The effect of obesity on polycystic ovary syndrome: a systematic review and meta-analysis. Obe Rev. 2013;14(2):95–109.CrossRef
12.
13.
Azziz R, Marin C, Hoq L, et al. Health care-related economic burden of the polycystic ovary syndrome during the reproductive life span. J Clin Endocrinol Metab. 2005;90(8):4650–8.PubMedCrossRef
14.
Teede HJ, Misso ML, Costello MF, et al. Recommendations from the international evidence-based guideline for the assessment and management of polycystic ovary syndrome. Hum Reprod. 2018;33(9):1602–18.PubMedPubMedCentralCrossRef
15.
The Amsterdam ESHRE/ASRM-Sponsored 3rd PCOS Consensus Workshop Group. Consensus on women's health aspects of polycystic ovary syndrome (PCOS). Hum Reprod. 2012;27(1):14–24.
16.
Nybacka A, Carlstrom K, Stahle A, et al. Randomized comparison of the influence of dietary management and/or physical exercise on ovarian function and metabolic parameters in overweight women with polycystic ovary syndrome. Fertil Steril. 2011;96(6):1508–13.PubMedCrossRef
17.
Thomson RL, Buckley JD, Noakes M, et al. The effect of a hypocaloric diet with and without exercise training on body composition, cardiometabolic risk profile, and reproductive function in overweight and obese women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2008;93(9):3373–80.PubMedCrossRef
18.
Haqq L, McFarlane J, Dieberg G, et al. The effect of lifestyle intervention on body composition, glycemic control, and cardiorespiratory fitness in polycystic ovarian syndrome: a systematic review and meta-analysis. Int J Sport Nutr Exerc Metab. 2015;25(6):533–40.PubMedCrossRef
19.
Al-Eisa ES, Gabr SA, Alghadir AH. Effects of supervised aerobic training on the levels of anti-Mullerian hormone and adiposity measures in women with normo-ovulatory and polycystic ovary syndrome. J Pak Med Assoc. 2017;67(4):499–507.PubMed
20.
Redman LM, Elkind-Hirsch K, Ravussin E. Aerobic exercise in women with polycystic ovary syndrome improves ovarian morphology independent of changes in body composition. Fertil Steril. 2011;95(8):2696–9.PubMedPubMedCentralCrossRef
21.
Costa EC, Sá DE, JCF, Stepto NK, et al. Aerobic training improves quality of life in women with polycystic ovary syndrome. Med Sci Sports Exerc. 2018;50(7):1357–66.PubMedCrossRef
22.
Mena GP, Mielke GI, Brown WJ. The effect of physical activity on reproductive health outcomes in young women: a systematic review and meta-analysis. Hum Reprod Update. 2019;25(5):541–63.PubMedCrossRef
23.
Benham JL, Yamamoto JM, Friedenreich CM, et al. Role of exercise training in polycystic ovary syndrome: a systematic review and meta-analysis. Clin Obe. 2018;8(4):275–84.CrossRef
24.
Hui C, Wang XJ, Wu XK. TCM pathogenesis of polycystic ovary syndrome based on the theory of reproduction visceral manifestation. World Science and Technology/Modernization of Traditional Chinese Medicine and Materia Medica. 2018;20.
25.
Qu F, Li R, Sun W, et al. Use of electroacupuncture and transcutaneous electrical acupoint stimulation in reproductive medicine: a group consensus. J Zhejiang Univ Sci B. 2017;18(3):186–93.PubMedPubMedCentralCrossRef
26.
Kang KB, Niu CX. Professor Pan Wen’s understanding to TCM etiology of polycystic ovary syndrome. Western Journal of Traditional Chinese Medicine. 2014;27(8):22–3.
27.
Wang B, Yan W, Hou LH, et al. Disorder of Tiangui (kidney essence) and reproductive dysfunction in patients with polycystic ovary syndrome. Journal of Chinese Integrative Medicine. 2010;8(11):1018–22.PubMedCrossRef
28.
Wang J, Wang Q, Li L, et al. Phlegm-dampness constitution: genomics, susceptibility, adjustment and treatment with traditional Chinese medicine. Am J Chin Med. 2013;41(02):253–62.PubMedCrossRef
29.
Song JJ, YM, Wu XK, et al. Progress of integrative Chinese and Western medicine in treating polycystic ovarian syndrome caused infertilit. Chin J Integr Med. 2006(4):312–6.
30.
31.
Jiang Y, Zou J. Analysis of the TCM theory of traditional Chinese health exercise. J Sport Health Sci. 2013;2(4):204–8.CrossRef
32.
Wu ZY, Dai JG. An analysis of progress in research on tendon-activating technique. Henan Traditional Chinese Medicine. 2017;37.
33.
Hong BH, Yao X, Chen B, et al. Research on effect and some mechanism of health Qigong Yi Jin Jing in treating primary dysmenorrheal symptoms. Modern Preventive Medicine. 2103;40(11):2040–3.
34.
Chen T, Wang R, Wei YQ, et al. Effects of Yi Jin Jing on sex hormone in 60–69 years old men. Chinese Journal of Reproduction and Contraception. 2018;38.
35.
Wang HJ, Lv XL. Influence of Yi Jin Jing practice on body composition of obesity university student. Journal of Sports Adult Education. 2015;31:64–6.
36.
Spritzer PM, Motta AB. Adolescence and polycystic ovary syndrome: current concepts on diagnosis and treatment. Inter J Clin Pract. 2015;69(11):1236–46.CrossRef
37.
Pavlik EJ, DePriest PD, Gallion HH, et al. Ovarian volume related to age. Gynecol Oncol. 2000;77(3):410–2.PubMedCrossRef
38.
The Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome. Fertil Steril. 2004;81(1):19–25.CrossRef
39.
Jedel E. Impact of electro-acupuncture and physical exercise on hyperandrogenism and oligo/amenorrhea in women with polycystic ovary syndrome:a randomized controlled trial. Am J Physiol Endocrinol Metab. 2011;300(1):E37–45.PubMedCrossRef
40.
Hiam D, Patten R, Gibson-Helm M, et al. The effectiveness of high intensity intermittent training on metabolic, reproductive and mental health in women with polycystic ovary syndrome: study protocol for the iHIT- randomised controlled trial. Trials. 2019;20(1):221.PubMedPubMedCentralCrossRef
41.
Buzney E, Sheu J, Buzney C, et al. Polycystic ovary syndrome: a review for dermatologists: Part II. Treatment. J Am Acad Dermatol. 2014;71(5):859 e1–e15; quiz 73–4.
42.
Duguech LMM, Legro RS. Pharmacologic treatment of polycystic ovary syndrome: alternate and future paths. Semi Reprod Med. 2017;35(4):326–43.CrossRef
43.
Ruan X, Song J, Gu M, et al. Effect of Diane-35, alone or in combination with orlistat or metformin in Chinese polycystic ovary syndrome patients. Arch Gynecol Obstet. 2018;297(6):1557–63.PubMedCrossRef
44.
Fraissinet A, Robin G, Pigny P, et al. Use of the serum anti-Mullerian hormone assay as a surrogate for polycystic ovarian morphology: impact on diagnosis and phenotypic classification of polycystic ovary syndrome. Hum Reprod. 2017;32(8):1716–22.PubMedCrossRef
45.
Dewailly D, Pigny P, Soudan B, et al. Reconciling the definitions of polycystic ovary syndrome: the ovarian follicle number and serum anti-Mullerian hormone concentrations aggregate with the markers of hyperandrogenism. J Clin Endocrinol Metab. 2010;95(9):4399–405.PubMedCrossRef
46.
Dumont A, Robin G, Dewailly D. Anti-mullerian hormone in the pathophysiology and diagnosis of polycystic ovarian syndrome. Curr Opin Endocrinol Diabetes Obes. 2018;25(6):377–84.PubMedCrossRef
47.
Moran LJ, Harrison CL, Hutchison SK, et al. Exercise decreases anti-mullerian hormone in aovulatory overweight women with polycystic ovary syndrome: a pilot study. Horm Metab Res. 2011;43(13):977–9.PubMedCrossRef
48.
Alalami H. Cardiovascular profile of pharmacological agents used for the management of polycystic ovary syndrome. Ther Adv Endocrinol Metab. 2018;10:2042018818805674.PubMedPubMedCentral
49.
Chao YF, Chen SY, Lan C, et al. The cardiorespiratory response and energy expenditure of Tai-Chi-Qui-Gong. Am J Chin Med. 2002;30(4):451–61.PubMedCrossRef
Metadata
Title
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
Authors
Jing Zhao
Antonnette Ketlhoafetse
Xiangyun Liu
Yang Cao
Publication date
01-12-2022
Publisher
BioMed Central
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06377-8

Other articles of this Issue 1/2022

Trials 1/2022 Go to the issue

Study protocol

Comparison of Buyang Huanwu granules and Naoxintong capsules in the treatment of stable angina pectoris: rationale and design of a randomized, blinded, multicentre clinical trial

Study protocol

A randomized wait-list controlled trial to investigate the role of cognitive mechanisms in parenting interventions on mothers with substance use disorder

Study protocol

Achieving Quality and Effectiveness in Dementia Using Crisis Teams (AQUEDUCT): a study protocol for a randomised controlled trial of a Resource Kit

Research

Consumer perspectives on simplified, layered consent for a low risk, but complex pragmatic trial

Study protocol

Effectiveness of the MULTIPAP Plus intervention in youngest-old patients with multimorbidity and polypharmacy aimed at improving prescribing practices in primary care: study protocol of a cluster randomized trial

Study protocol

Social network-based group intervention to promote HIV prevention in Uganda: study protocol for a cluster randomized controlled trial of Game Changers