Effectiveness of LiuZiJue Qigong versus traditional core stability training for poststroke patients complicated with abnormal trunk postural control: study protocol for a single-center randomized controlled trial.

BACKGROUND: Trunk function in stroke patients with hemiplegia is associated with respiration and core stability and is also found to be associated with balance and postural control and activities of daily living. LiuZiJue Qigong (LQG) is a traditional Chinese method of fitness based on breath pronunciation. The purpose of this study is to compare the clinical efficacy of LQG and traditional core stability training in the treatment of stroke patients with abnormal trunk posture. This protocol is written according to the SPIRIT 2013 statement. METHODS/DESIGN: This study is a single-center randomized controlled trial in which 160 stroke patients are randomly divided into a study group and a control group. Patients in the study group will receive LQG combined with conventional rehabilitation therapy, and patients in the control group will receive traditional core stability training combined with conventional rehabilitation therapy. All treatments will be done for 45 min/day, five times per week, for 2 weeks. The primary outcome (Trunk Impairment Scale) and secondary outcomes (Berg Balance Scale, Fugl-Meyer Assessment, Modified Barthel Index, Maximum Phonation Time, Dynamic and Static balance testing, and thickness and the mobile degrees of diaphragm) will be measured at baseline, 2 weeks, and the end of the rehabilitation course. DISCUSSION: The aim purpose of this research study is to compare the clinical efficacy of LQG and traditional core stability exercise in the treatment of stroke patients with abnormal trunk posture. TRIAL REGISTRATION: Chinese Clinical Trial Register, ChiCTR1800014864. Registered on 24 November 2018.

Effect of aerobic exercise and low carbohydrate diet on pre-diabetic non-alcoholic fatty liver disease in postmenopausal women and middle aged men--the role of gut microbiota composition: study protocol for the AELC randomized controlled trial.

BACKGROUND: Pre-diabetes and non-alcoholic fatty liver disease (NAFLD) are associated with an unhealthy lifestyle and pose extremely high costs to the healthcare system. In this study, we aim to explore whether individualized aerobic exercise (AEx) and low carbohydrate diet (LCh) intervention affect hepatic fat content (HFC) in pre-diabetes via modification of gut microbiota composition and other post-interventional effects. METHODS/DESIGN: A 6-month randomized intervention with 6-month follow-up is conducted from January 2013 to December 2015. The target sample size for intervention is 200 postmenopausal women and middle-aged men aged 50-65 year-old with pre-diabetes and NAFLD. The qualified subjects are randomized into 4 groups with 50 subjects in each group: 1 = AEx, 2 = LCh, 3 = AEx + LCh, and 4 = control. In addition, two age-matched reference groups (5 = pre-diabetes without NAFLD (n = 50) and 6 = Healthy without pre-diabetes or NAFLD (n = 50)) are included. The exercise program consists of progressive and variable aerobic exercise (intensity of 60 to 75% of initial fitness level, 3-5 times/week and 30-60 min/time). The diet program includes dietary consultation plus supplementation with a special lunch meal (40% of total energy intake/day) which aims to reduce the amount of carbohydrate consumption (30%). The control and reference groups are advised to maintain their habitual habits during the intervention. The primary outcome measures are HFC, serum metabolomics and gut microbiota composition. The secondary outcome measures include body composition and cytokines. In addition, socio-psychological aspects, social support, physical activity and diet will be performed by means of questionnaire and interview. DISCUSSION: Specific individualized exercise and diet intervention in this study offers a more efficient approach for liver fat reduction and diabetes prevention via modification of gut microbiota composition. Besides, the study explores the importance of incorporating fitness assessment and exercise in the management of patients with pre-diabetes and fatty liver disorders. If our program is shown to be effective, it will open new strategies to combat these chronic diseases. TRIAL REGISTRATION: Current Controlled Trials: ISRCTN42622771.