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Tai chi for overweight/obese adolescent and young women with polycystic ovary syndrome: study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Tai Chi is a moderately intense exercise that dates back to ancient China. It has been reported that Tai Chi not only has beneficial effects on metabolic disorders, such as diabetes, cardiovascular diseases and obesity, but also has favorable effects on psychological well-being. Since these conditions are quite closely associated with polycystic ovary syndrome (PCOS), we hypothesis that Tai Chi could be a potential treatment option for PCOS patients. We aim to determine the feasibility and effectiveness of Tai Chi on overweight/obese adolescent and young women with PCOS. METHODS:A total of 50 patients will be randomized into two arms: (1) Tai Chi or (2) self-monitored exercise. Both groups will exercise for 3 months. The primary hypothesis is that Tai Chi results in a significantly lower Body Mass Index (BMI) than self-monitored exercise. The study was approved by the Ethics Committee of the First Affiliated Hospital of Heilongjiang University of Chinese Medicine. DISCUSSION:This is the first study to determine the feasibility and effectiveness of Tai Chi in treating overweight/obese adolescent and young women with PCOS. The trial will provide evidence to assess the feasibility of a future multicenter, randomized controlled trial. TRIAL REGISTRATION:ClinicalTrials.gov, ID: NCT02608554 . Registered on 17 November 2015.

SUBMITTER: Li Y

PROVIDER: S-EPMC6149209 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Tai chi for overweight/obese adolescent and young women with polycystic ovary syndrome: study protocol for a randomized controlled trial.

Li Yan Y Peng Changle C Cao Guangying G Li Wei W Hou Lihui L

Trials 20180920 1

<h4>Background</h4>Tai Chi is a moderately intense exercise that dates back to ancient China. It has been reported that Tai Chi not only has beneficial effects on metabolic disorders, such as diabetes, cardiovascular diseases and obesity, but also has favorable effects on psychological well-being. Since these conditions are quite closely associated with polycystic ovary syndrome (PCOS), we hypothesis that Tai Chi could be a potential treatment option for PCOS patients. We aim to determine the fe ...[more]

PMID: 30236149

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Project description:BackgroundObesity and insulin resistance (IR) are common features of polycystic ovary syndrome (PCOS). Metformin (MET) increases insulin sensitivity, but it is associated with unsatisfactory weight loss. The glucagon-like peptide-1 receptor agonist exenatide has been shown to reduce weight and IR in patients with diabetes. This study aimed to explore the therapeutic effects of exenatide once-weekly (QW) combined with MET on body weight, as well as metabolic and endocrinological parameters in overweight/obese women with PCOS.MethodsFifty overweight/obese women with PCOS diagnosed via the Rotterdam criteria were randomized to one of two treatment groups: MET (500 mg three times a day [TID]) or combination treatment (COM) (MET 500 mg TID, exenatide 2 mg QW) for 12 weeks. The primary outcomes were anthropometric changes associated with obesity, and the secondary outcomes included changes in reproductive hormone levels, glucose and lipid metabolism, and C-reactive protein.ResultsForty (80%) patients completed the study. COM therapy was superior to MET monotherapy in reducing weight (P = 0.045), body mass index (BMI) (P = 0.041), and waist circumference (P = 0.023). Patients in the COM group on an average lost 3.8 ± 2.4 kg compared with 2.1 ± 3.0 kg in the MET group. In the COM group, BMI and waist circumference decreased by 1.4 ± 0.87 kg/m2 and 4.63 ± 4.42 cm compared with 0.77 ± 1.17 kg/m2 and 1.72 ± 3.07 cm in the MET group, respectively. Moreover, levels of fasting glucose, oral glucose tolerance test (OGTT) 2-h glucose, and OGTT 2-h insulin were significantly lower with COM therapy than with MET (P < 0.050). Mild and moderate gastrointestinal reactions were the most common adverse events in both groups.ConclusionsCOM therapy was more effective than MET alone in reducing body weight, BMI, and waist circumference, and improving insulin sensitivity in overweight/obese women with PCOS, with acceptable short-term side effects.Trial registrationClinicalTrials.gov, NCT04029272. https://clinicaltrials.gov/ct2/show/NCT04029272.

Project description:BackgroundPolycystic 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.MethodsThe 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.DiscussionThis 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 registrationChinese Clinical Trial Registry ChiCTR1900022385 . Registered on 9 April 2019.

Project description:Background/objectives: Polycystic ovary syndrome (PCOS) is a common condition in reproductive-aged women. Weight management is a first-line treatment for PCOS according to international evidence-based guidelines. However, the factors associated with attrition or success in weight loss interventions are not known for women with PCOS. The objective of this study was to identify characteristics associated with attrition and weight loss success in women with PCOS and overweight or obesity undergoing weight loss interventions. Methods: Four randomised controlled clinical weight loss trials comprising energy restricted diets and/or exercise interventions of 2⁻8 months duration. The interventions were conducted over 2001⁻2007 in outpatient clinical research centres with n = 221 premenopausal women with PCOS and overweight/obesity recruited through community advertisement. The main outcome measures were attrition and ≥5% weight loss at 2 months and study completion. Results: Weight loss was 5.7 ± 2.9 kg at 2 months and 7.4 ± 5.3 kg after study completion (p < 0.001). Attrition was 47.1% and ≥5% weight loss occurred in 62.5% and 62.7% of women at 2 months and study completion respectively. Baseline depressive symptoms (OR 1.07 95% CI 0.88, 0.96, p = 0.032) and lower appointment attendance by 2 months (OR 0.92 95% CI 0.88, 0.96, p < 0.001) were independently associated with attrition. Lower appointment attendance over the whole study was independently associated with not achieving ≥5% weight loss at study completion (OR 0.95 95% CI 0.92, 0.99, p = 0.020). Conclusions: Despite high attrition, successful weight loss was achieved by 63% of women with PCOS in a clinical research setting. Higher baseline depressive symptoms were associated with greater attrition and higher appointment attendance was associated with lower attrition and greater weight loss success. These finding have implications for development of successful weight management programs in PCOS.

Project description:BACKGROUND:Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women during reproductive age. It is characterised clinically by oligo-ovulation or anovulation, hyper-androgenism, and the presence of polycystic ovaries. It is associated with an increased prevalence of metabolic syndrome, cardiovascular disease and type 2 diabetes. The onset of PCOS has been associated to several hereditary and environmental factors, but insulin resistance plays a key pathogenetic role. We sought to investigate the effects of a ketogenic diet (KD) on women of childbearing age with a diagnosis of PCOS. METHODS:Fourteen overweight women with diagnosis of PCOS underwent to a ketogenic Mediterranean diet with phyoextracts (KEMEPHY) for 12 week. Changes in body weight, body mass index (BMI), fat body mass (FBM), lean body mass (LBM), visceral adipose tissue (VAT), insulin, glucose, HOMA-IR, total cholesterol, low density lipoprotein (LDL), high density lipoprotein (HDL), triglycerides (TGs), total and free testosterone, luteinizing hormone (LH), follicle stimulating hormone (FSH); dehydroepiandrosterone sulfate (DHEAs), estradiol, progesterone, sex hormone binding globulin (SHBG) and Ferriman Gallwey score were evaluated. RESULTS:After 12 weeks, anthropometric and body composition measurements revealed a significant reduction of body weight (-?9.43 kg), BMI (-?3.35), FBM (8.29 kg) and VAT. There was a significant, slightly decrease of LBM. A significant decrease in glucose and insulin blood levels were observed, together with a significant improvement of HOMA-IR. A significant decrease of triglycerides, total cholesterol and LDL were observed along with a rise in HDL levels. The LH/FSH ratio, LH total and free testosterone, and DHEAS blood levels were also significantly reduced. Estradiol, progesterone and SHBG increased. The Ferriman Gallwey Score was slightly, although not significantly, reduced. CONCLUSIONS:Our results suggest that a KD may be considered as a valuable non pharmacological treatment for PCOS. Longer treatment periods should be tested to verify the effect of a KD on the dermatological aspects of PCOS. Trial registration Clinicaltrial.gov, NCT04163120, registrered 10 November 2019, retrospectively registered, https://clinicaltrials.gov.

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Tai chi for overweight/obese adolescent and young women with polycystic ovary syndrome: study protocol for a randomized controlled trial.

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Tai chi for overweight/obese adolescent and young women with polycystic ovary syndrome: study protocol for a randomized controlled trial.

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