Resistance training with blood flow restriction and cognition in elderly women (project "forte-mente-ativa"): study protocol

Abstract Aim: In the process of aging, there is a decrease on muscle strength and cognitive function. Resistance training combined with blood flow restriction (BFRRT) has been shown capable of maintaining or improve aspects of physical health. However, the effects of BFRRT the cognitive function of the elderly are not clear. This study aimed to describe the design of a randomized controlled clinical trial, that will investigate the effects of BFRRT on cognitive function, physical performance and physiological and morphological aspects in elderly women. Methods: Forty participants will be randomized into one of the following groups: low load resistance training, blood flow restriction resistance training, moderate load resistance training or Control. All intervention groups will complete 16 weeks of resistance training, three times week (45 minutes each), with training consisting of four exercises for the upper and lower body, including three sets of ten repetitions each. No exercise will be performed by the Control group. Cognitive function will be the primary outcome of the study. Secondary outcomes will include body composition, muscle strength, functional capacity, double-task, level of physical activity, static and dynamic balance, brain activity, BDNF neurotrophic factor, anxiety, depression and sleep state). Conclusion: This project will contribute to the existing knowledge and will have a social impact regarding the use of physical exercise as a non-pharmacological tool for the mental and physical health older individuals. Trial Registration: Brazilian Registry of Clinical Trials number RBR-7BC8ZP.

National Nutrition and Health Systematic Survey for Children 0-17 Years of Age in China / 生物医学与环境科学（英文）

The main purpose of the National Nutrition and Health Systematic Survey for children 0-17 years of age in China (CNHSC) was to collect basic data on the nutrition, development, and health status for children in different regions across China using evidence-based, reliable, and cost-effective approaches. Children and their parents or guardians from seven regions (south, southwest, north, northwest, eastern, central, and northeast China) in China were recruited. A multi-stage stratified randomized sampling method was used. Two provinces were randomly sampled from each of the seven regions, from which one urban district and one rural country were also randomly sampled, resulting in a total of 28 survey counties/districts. Dietary surveys, health examinations, laboratory testing, and questionnaires were used to collect dietary intake, nutritional status, child development, and health status information. Nutrition, health, and lifestyle assessment of children and their parents was determined using the Knowledge Attitude Practice (KAP) survey. Greater than 100,000 children (38,000 children < 6 years of age and 66,000 children 6-17 years of age) completed the survey. The survey provided comprehensive data on child nutrition and health status for future studies and will serve as the basis for an integrated nutrition and health improvement strategies proposal for children in China.

Malnutrition and its associated factors among children under 5 years old in Putrajaya: a study protocol

@#Introduction: Prevalence of malnourished children in Putrajaya was unexpectedly high in 2016. This paper describes the study protocol for a case-control study conducted to identify the associated factors of malnutrition among children under 5 years old in Putrajaya. Methods: This study involved two phases. Phase I was ‘screening’ where all children aged 6-59 months in 118 preschools and four government health clinics were measured for their weight and height. The World Health Organization Anthro software was used to determine the nutritional status of these children. Phase II was the ‘interview’ where children from screening were sampled into four pairs of case and control. The optimum sample size for the case of stunted, wasted, underweight, and overweight were 380, 335, 318, and 308, respectively. The same number of controls were recruited. Parents/caregivers of selected children were approached to obtain data on parental factors, children factors, food intake factors, and environmental factors that contributed to malnutrition. Data analysis was performed by multiple logistic regression in SPSS version 26. Results: Screening phase successfully measured 8,261 (50.1%) children from an estimated 16,500 children under 5 years old in Putrajaya. The number of children who were stunted, wasted, underweight, and overweight were 2,105 (25.5%), 512 (6.2%), 1,516 (18.4%), and 248 (3.0%), respectively. As overweight was undersampled, the number of controls for overweight was doubled to increase the power of the study. Parents/caregivers of selected cases and controls were interviewed in their household or any other venues at their convenience. Conclusion: This protocol promises beneficial outputs to stakeholders and policy makers that can be used for combating malnutrition in children.

Effectiveness of a 12-week physical exercise programme on blood pressure in adults with true resistant hypertension and high risk of obstructive sleep apnoea: a study protocol for a pre-post test non randomised clinical trial

Background:Resistant hypertension, a special phenotype of hypertension, is associated with increased cardiovascular risk. Exercise and physical activity are recommended as non-pharmacological interventions to manage blood pressure in hypertension. Little is known about the effectiveness of exercise in resistant hypertension. A bidirectional relationship has been identified between resistant hypertension and obstructive sleep apnoea but the literature pertaining to the benefit of exercise for populations with both conditions, is minimal. This study aims to identify the effectiveness of exercise in reducing blood pressure in a cohort of adults with resistant hypertension and high risk of obstructive sleep apnoea.Methods:Dunedin based adults with resistant hypertension and high risk of obstructive sleep apnoea will be recruited from the community and health centres to participate in the study. Consenting volunteers (no. of fourteen) will participate in a 12-week exercise programme including aerobic and strength training. The primary outcome measure will be 24h ambulatory blood pressure while the secondary outcomes will be anthropometrics, activity parameters, sleep parameters, cardiac structure and function, and quality of life. The measurements at the end ofthe 12-week exercise programme will be compared with baseline to determine the effectiveness of exercise in reducing blood pressure in the cohort with resistant hypertension and risk of obstructive sleep apnoea. Conclusions: Exercise and physical activity are recommended to manage hypertension. Therefore, it is anticipated that the exercise programme will have a positive effect on the blood pressure of the participants. The findings have potential to change the direction of research in the area by fillingthe knowledge gaps.Trial Registration:The Ministry of Health, New Zealand (Ethics Ref: 18/CEN/257), Trial registry: ACTRN12618001881224p).

Effects of Resistance Exercise with Instability on Neurocognitive Functions (REI STUDY): Study Protocol for a Proof-of-Concept Clinical Trial in Older Adults with Subjective Cognitive Complaints

Aim: Resistance exercise (RE) is a widely accepted strategy to counteract the effects of aging and chronic diseases on health-related outcomes. Studies have been suggested that RE improves brain and cognitive health. RE with unstable devices (REI) is a neuromotor complexity strategy with the potential to improve strength, power, and balance in onder adults, however, their effects on neurocognitive function in individuals at risk of cognitive decline are poorly understood. Thus, we describe the REI study protocol, a randomized clinical trial design to assess the effects of 12-weeks of REI and RE on neurocognitive functions in older adults with subjective cognitive complaints. Methods: The sample will consist of individuals (aged 65 or older) with subjective cognitive complaints, who will be randomized in one of three experimental groups: control, RE or REI. Participants of the RE group will receive 12-weeks of progressive resistance training (seven exercises structured into 3 sets of 10-15 repetitions maximum, three times per week). Participants of the REI group will receive the same RE protocol performed on unstable devices that promote progressive instability. The control group received a health education program. The primary outcome is a composite score of neurocognitive functions. Secondary outcomes include each separately neurocognitive domain, functional performance, balance, falls-related parameters, cardiovascular and mood variables. The study results will provide information to design a future and larger preventive trial on populations at risk of cognitive decline and dementia, which is imperative in public health terms. Trial registration: Brazilian registry of clinical trials number RBR-4kqs22.(AU)

Effects of acupuncture in treating insomnia due to spleen-stomach disharmony syndrome and its influence on intestinal microbiome: Study protocol for a randomized controlled trial / 中西医结合学报

BACKGROUND@#Insomnia is a common complaint that is closely related to gastrointestinal symptoms, which is consistent with the traditional Chinese medicine classical theory of "stomach disharmony leading to restless sleep." Acupuncture is an effective complementary and alternative medicine therapy to improve gastrointestinal function and restore the normal sleep-wake cycle. However, studies on the effectiveness of acupuncture for insomnia due to spleen-stomach disharmony syndrome are limited to case reports and few randomized controlled trials; deeper research on its mechanism is still lacking. This randomized controlled trial aims to assess the treatment efficacy of "harmonizing stomach to tranquilize mind" acupuncture for insomnia and its influence on the intestinal microbiome.@*METHODS/DESIGN@#This is a randomized, single-blind, parallel-group study. Sixty eligible patients with insomnia due to spleen-stomach disharmony syndrome will be randomly divided into two groups (1:1 allocation ratio). The intervention group will use "harmonizing stomach to tranquilize mind" acupuncture, and the control group will receive sham acupuncture. Participants will receive 5 acupuncture treatment sessions per week for 4 consecutive weeks. The Pittsburgh Sleep Quality Index will be used to evaluate the clinical efficacy of acupuncture treatment by making assessments at baseline, the end of treatment and the end of the follow-up. High-throughput 16S ribosomal ribonucleic acid gene sequencing will be performed to detect changes in the intestinal microbial composition before and after treatment.@*DISCUSSION@#The results of this trial are expected to confirm that "harmonizing stomach to tranquilize mind" acupuncture can effectively relieve insomnia and alter the intestinal microbiome.@*TRIAL REGISTRATION@#Chinese Clinical Trials Registry: ChiCTR1800017092.

Fire-needle acupuncture for upper limb spastic paralysis after stroke: Study protocol for a randomized controlled trial / 中西医结合学报

BACKGROUND@#Fire-needle acupuncture, an important kind of acupuncture therapy, has been clinically used to treat upper limb spastic paralysis (ULSP) after stroke. Clinical experience has indicated that fire-needle acupuncture treatment takes less time, requires fewer visits, and has more rapid results and fewer side effects compared to chemical medicine alternatives. This study will evaluate the effects of fire-needle acupuncture for ULSP in the context of standardized clinical research and provide high-quality data to inform clinical procedures and future study design.@*METHODS/DESIGN@#A randomized controlled trial will be carried out to evaluate the effects of fire-needle acupuncture therapy in patients with ULSP from stroke. ULSP patients (n = 120) will be recruited at Changhai Hospital in Shanghai, China. Patients will be randomly divided into three groups, including fire-needle acupuncture group (FAG), filiform-needle acupuncture group (FFAG) and rehabilitation treatment group (RTG). During the 3-week treatment, the FAG will be treated every two days, while FFAG and RTG will be treated 5 d in a row and then rest for 2 d. The Simplified Fugl-Meyer Motor Function Scale and Modified Ashworth Scale will be used as the primary outcome measures. Statistical analysis will be conducted by an independent statistician.@*DISCUSSION@#Through this study, the utility of fire-needle acupuncture in treating ULSP after stroke will be tested, and some specific claims of fire-needle acupuncture therapy will be evaluated, such as relieving spasm and muscular tension, improving activities of daily living, rapidity of response and less frequency of treatment compared with other treatments.@*TRIAL REGISTRATION@#Chinese Clinical Trial Registry (identifier: ChiCTR-IOR-17013875; registration date: 28 December 2016).

Diagnostic Accuracy of Chinese Medicine Diagnosis Scale of Phlegm and Blood Stasis Syndrome in Coronary Heart Disease: A Study Protocol / 中国结合医学杂志

BACKGROUND@#Phlegm and blood stasis syndrome (PBSS) is one of the main syndromes in coronary heart disease (CHD). Syndromes of Chinese medicine (CM) are lack of quantitative and easy-implementation diagnosis standards. To quantify and standardize the diagnosis of PBSS, scales are usually applied.@*OBJECTIVE@#To evaluate the diagnostic accuracy of CM diagnosis scale of PBSS in CHD.@*METHODS@#Six hundred patients with stable angina pectoris of CHD, 300 in case group and 300 in control group, will be recruited from 5 hospitals across China. Diagnosis from 2 experts will be considered as the "gold standard". The study design consists of 2 phases: pilot test is used to evaluate the reliability and validity, and diagnostic test is used to assess the diagnostic accuracy of the scale, including sensitivity, specificity, likelihood ratio and area under the receiver operator characteristic (ROC) curve.@*DISCUSSION@#This study will evaluate the diagnostic accuracy of CM diagnosis scale of PBSS in CHD. The consensus of 2 experts may not be ideal as a "gold standard", and itself still requires further study. (No. ChiCTR-OOC-15006599).

Effectiveness of two different acupuncture strategies in patients with vulvodynia: Study protocol for a pilot pragmatic controlled trial / 中西医结合学报

<p><b>BACKGROUND</b>Vulvodynia, or vulvar pain, is a common condition in women; however, there are few evidence-based clinical trials evaluating nonpharmacological therapies for this condition. Acupuncture is one complementary and integrative medicine therapy used by some patients with vulvodynia. This study evaluates two different acupuncture strategies for the treatment of vulvodynia and aims to evaluate whether either of the acupuncture protocols reduces vulvar pain, pain duration or pain with intercourse. The study also examines how long the effect of acupuncture lasts in women with vulvodynia.</p><p><b>METHODS/DESIGN</b>The study is designed as a randomized controlled trial, focused on two acupuncture protocols. Fifty-one patients who have had vulvodynia for more than 3 months will be recruited. Among them, 34 patients will be randomized into Groups 1a and 1b; those who are unwilling to receive acupuncture will be recruited into the standard care group (Group 2). Patients in Group 1a will have acupuncture focused on the points in the pudendal nerve distribution area, while patients in Group 1b will receive acupuncture focused on traditional (distal) meridian points. Patients in Group 2 will receive routine conventional treatments, such as using pain medications, local injections and physical therapies or other nonsurgical procedures. Acupuncture will last 45 min per session, once or twice a week for 6 weeks. The primary outcome measurement will be objective pain intensity, using the cotton swab test. The secondary outcome measurement will be subjective patient self-reported pain intensity, which will be conducted before cotton swab test. Pain intensities will be measured by an 11-point Numeric Pain Rating Scale. Pain duration and pain score during intercourse are recorded. Local muscle tension, tenderness and trigger points (Ashi points) are also recorded. All measurements will be recorded at baseline (before the treatment), at the end of each week during treatment and at the end of the 6 weeks. Follow-up will be done 6 weeks following the last treatment.</p><p><b>DISCUSSION</b>Results of this trial will provide preliminary data on whether acupuncture provides better outcomes than nonacupuncture treatments, i.e., standard care, and whether acupuncture focused on the points in pudendal nerve distribution, near the pain area, has better results than traditional acupuncture focused on distal meridian points for vulvodynia.</p><p><b>TRIAL REGISTRATION</b>Clinicaltrials.gov: NCT03481621. Register: March 29, 2018.</p>

Defining Acupuncture-Moxibustion: A Delphi Study Protocol / 中国结合医学杂志

<p><b>BACKGROUND</b>With the worldwide use and modern development of acupuncture-moxibustion, there is disagreement on its basic definition. There has been an obstacle for clinical practice, research, and legislation. Considering this challenge, the World Federation of Acupuncture-Moxibustion Societies proposes to develop the definition and basic scope of acupuncture-moxibustion with a Delphi study.</p><p><b>METHODS</b>A reactive Delphi method will be used to ask a group of experts to rate the relevance and clarity of a predesigned initial item list. This list was generated by the steering committee through a literature review and group discussion. Forty experts will be selected from many disciplines and continents to ensure appropriate representation. Predefined rules will be applied to modify the items until a consensus is achieved. After achieving the consensus on all items through the survey round, the steering committee will form the definition and basic scope of acupuncture-moxibustion by organizing a literal statement with a detailed explanation.</p>

Study on Transitions in Employment, Ability and Motivation (STREAM): The Design of a Four-year Longitudinal Cohort Study among 15,118 Persons Aged 45 to 64 Years.

Aims: The objective of the Study on Transitions in Employment, Ability and Motivation (STREAM) is to acquire knowledge on determinants of transitions in employment and work productivity among persons aged 45-64 years. Research Framework: A research framework was developed, in which transitions in employment (e.g. leaving the workforce, entering the workforce, job change) and work productivity are influenced by the following determinants: health, job characteristics, skills and knowledge, social factors, and financial factors. Central explanatory variables in the framework are the ability to work, the motivation to work, and the opportunity to work. Study Design: STREAM is a prospective cohort study among 12,055 employees, 1,029 self-employed persons, and 2,034 non-working persons, all aged 45 to 64 years at baseline. The study sample was stratified by age and employment status (employed, self-employed, non-working), and was drawn from an existing internet panel. The baseline measurement was carried out in 2010 (response: 70%), and with yearly followup measurements in 2011 (response: 82%), 2012 (response: 80%), and 2013. At each wave, participants fill out an online questionnaire covering all aspects of the research framework. Place and Duration of Study: The Netherlands, between October 2010 and December 2013. Methodology: Quantitative data on all aspects of the research framework were assessed with an online questionnaire, qualitative data were assessed with interview studies, and the questionnaire data can be linked to register data at Statistics Netherlands for 89% of the participants. Results: Transitions in employment between the first three waves of data among the participants are described. Conclusion: STREAM will provide insight in the determinants of healthy and productive labour participation among persons aged 45 years and older, which will support the development of interventions prolonging working life in good health, while maintaining good work productivity.