Acute Effects of the Dry Needling Session on Gastrocnemius Muscle Biomechanical Properties, and Perfusion with Latent Trigger Points - A Single-Blind Randomized Controlled Trial in Mixed Martial Arts Athletes.

The study aimed to evaluate the immediate effects of a dry needling (DN) therapy session on biomechanical properties, muscle power, perfusion, and pressure pain threshold of the gastrocnemius muscle with latent trigger points. Twenty mixed martial arts athletes (MMA) were randomly divided into two groups: experimental (eDN, n = 10) and sham (qDN, n = 10) to undergo one session of DN either with a real or a qazi needle. The measurements were taken at rest, 1-5 minutes after the DN (Post1-5min) and 24h after the DN (Post24h). DN significantly increased the muscle perfusion (Post1-5min and Post24h, p < 0.001), reduced its tone (Post1-5min and Post24h, p < 0.001) and stiffness (Post1-5min, p < 0.05; Post24 h, p < 0.001), and improved its elasticity (Post1-5min and Post24h, p < 0.001). DN also caused a significant increase in pressure pain threshold (Post1-5min, p < 0.001; Post24h, p < 0.05) and in muscle power (Post24h, p < 0.01). The DN session increased the blood perfusion and improved the biomechanical properties of the gastrocnemius muscle, which led to improved muscle power. The DN also had an analgesic effect. These effects were maintained at 24 h, which suggests that DN could facilitate muscle recovery in a post-exercise period of MMA athletes.

Does an antihypertensive diet cost more? Analysis from the Chinese Heart-Healthy diet trial.

OBJECTIVE: To determine whether the Chinese heart-healthy diet (Sichuan cuisine version) (CHH diet-SC) was more expensive than the conventional Sichuan diet and explore the food groups and nutrients that mainly affected the cost of CHH diet-SC. DESIGN: Cost analysis of 4-week intervention diets in the Sichuan center representing southwestern China in the CHH diet study. SETTING: A multicentre, parallel-group, single-blind, randomised feeding trial evaluating the efficacy of lowering blood pressure with the cuisine-based CHH diet. PARTICIPANTS: Totally, fifty-three participants with hypertension aged 25-75 years in the Sichuan center were randomised into the control group (n 26) or the CHH diet-SC group (n 27). RESULTS: The CHH diet-SC was more expensive than the control diet (¥27·87 ± 2·41 v. ¥25·18 ± 2·79 equals $3·90 ± 0·34 v. $3·52 ± 0·39, P < 0·001), and the incremental cost-effectiveness ratio for a 1-mm Hg systolic blood pressure reduction was ¥9·12 ($1·28). Intakes and the cost of seafood, dairy products, fruits, soybeans and nuts, whole grains and mixed beans were higher for the CHH diet-SC than for the control diet (P < 0·001). Intakes of vitamin B1, vitamin B6, vitamin C, Mg and phosphorus were positively correlated with the cost (P < 0·05). CONCLUSIONS: The CHH diet-SC costs more than the conventional Sichuan diet, partly due to the high cost of specific food groups. Positive correlations between the intakes of vitamin B1, vitamin B6, vitamin C, Mg, phosphorus and the dietary cost could be a direction to adjust the composition within the food groups to reduce the cost of the CHH diet-SC.

Effect of mHealth-based relaxation program on stress coping and anxiety levels in mothers of children with cancer: A randomized controlled study.

OBJECTIVE: This study aimed to explore the effects of a mHealth-based relaxation program on anxiety and stress coping levels in mothers of children with cancer. METHODS: This randomized controlled, single-blind, parallel-group trial was conducted in the pediatric hematology-oncology unit of a university hospital. The study was completed by 50 mothers (intervention group: n = 25; control group: n = 25). The mothers in the intervention group participated in a mHealth-based relaxation program for eight weeks (including progressive muscle relaxation, guided imagery, and the four-leaf clover of mindfulness). Videos of the relaxation program were sent to mothers' WhatsApp accounts. The mothers in the control group received routine care. The State-Trait Anxiety and Stress Coping Scales were administered during the first and eighth weeks. The registration number of this study on ClinicalTrials.gov is NCT05807295. RESULTS: Mothers who participated in the relaxation program had lower anxiety levels and higher stress-coping scores than those in the control group (p < 0.05). CONCLUSION: Progressive muscle relaxation exercises, guided imagery, and cognitive-based therapeutic approaches were effective in reducing mothers' anxiety and stress coping. PRACTICE IMPLICATIONS: Pediatric oncology nurses can apply mHealth-based relaxation programs to support caregivers, particularly mothers. In this way, ensuring the continuity and integrity of care is easy.

Accelerating P300-based neurofeedback training for attention enhancement using iterative learning control: a randomised controlled trial.

Objective. Neurofeedback (NFB) training through brain-computer interfacing has demonstrated efficacy in treating neurological deficits and diseases, and enhancing cognitive abilities in healthy individuals. It was previously shown that event-related potential (ERP)-based NFB training using a P300 speller can improve attention in healthy adults by incrementally increasing the difficulty of the spelling task. This study aims to assess the impact of task difficulty adaptation on ERP-based attention training in healthy adults. To achieve this, we introduce a novel adaptation employing iterative learning control (ILC) and compare it against an existing method and a control group with random task difficulty variation.Approach. The study involved 45 healthy participants in a single-blind, three-arm randomised controlled trial. Each group underwent one NFB training session, using different methods to adapt task difficulty in a P300 spelling task: two groups with personalised difficulty adjustments (our proposed ILC and an existing approach) and one group with random difficulty. Cognitive performance was evaluated before and after the training session using a visual spatial attention task and we gathered participant feedback through questionnaires.Main results. All groups demonstrated a significant performance improvement in the spatial attention task post-training, with an average increase of 12.63%. Notably, the group using the proposed iterative learning controller achieved a 22% increase in P300 amplitude during training and a 17% reduction in post-training alpha power, all while significantly accelerating the training process compared to other groups.Significance. Our results suggest that ERP-based NFB training using a P300 speller effectively enhances attention in healthy adults, with significant improvements observed after a single session. Personalised task difficulty adaptation using ILC not only accelerates the training but also enhances ERPs during the training. Accelerating NFB training, while maintaining its effectiveness, is vital for its acceptability by both end-users and clinicians.

Auricular Acupressure on Breast Pain Among Breastfeeding Mothers Receiving Gentle Hand Techniques: A Randomized, Single-Blind, Sham-Controlled Trial.

BACKGROUND: Auricular acupressure influences pain reduction in patients with diseases. However, study results on its influence on breast pain, common among breastfeeding mothers, are insufficient. RESEARCH AIM: This study aimed to explore the effectiveness of auricular acupressure on breast pain among breastfeeding mothers who also received a standard gentle hand technique. METHODS: This was a placebo-controlled study wherein auricular acupressure was provided for 4 weeks to 52 breastfeeding mothers consulting a local breastfeeding clinic. In the intervention group, auricular acupressure was applied to specific acupoints, including Shenmen, central rim, breast, and endocrine, which are related to breast pain and postpartum lactation. For the placebo control group, auricular acupressure was applied to acupoints not related to breast pain. The degree of breast pain was assessed using a numeric rating scale and a pressure algometer. RESULTS: After 4 weeks of auricular acupressure, numeric rating scale pain scores did not show a significant change. However, the pressure pain threshold for the upper left (Z = -2.202, p = .028) and upper right (t = 2.613, p = .012) areas of the right breast increased significantly in the intervention group. CONCLUSION: This study employed subjective and objective measurements to evaluate the efficacy of auricular acupressure in alleviating breast pain. The intervention shows potential as a nursing measure. Further research is required to determine the optimal intervention duration and frequency, particularly for breastfeeding parents with severe pain, and to evaluate long-term outcomes.

Comparison of the efficacy and tolerability of elobixibat plus sodium picosulfate with magnesium citrate and split-dose 2-L polyethylene glycol with ascorbic acid for bowel preparation before outpatient colonoscopy: a study protocol for the multicentre, randomised, controlled E-PLUS trial.

BACKGROUND: Sodium picosulfate (SP)/magnesium citrate (MC) and polyethylene glycol (PEG) plus ascorbic acid are recommended by Western guidelines as laxative solutions for bowel preparation. Clinically, SP/MC has a slower post-dose defaecation response than PEG and is perceived as less cleansing; therefore, it is not currently used for major bowel cancer screening preparation. The standard formulation for bowel preparation is PEG; however, a large dose is required, and it has a distinctive flavour that is considered unpleasant. SP/MC requires a small dose and ensures fluid intake because it is administered in another beverage. Therefore, clinical trials have shown that SP/MC is superior to PEG in terms of acceptability. We aim to compare the novel bowel cleansing method (test group) comprising SP/MC with elobixibat hydrate and the standard bowel cleansing method comprising PEG plus ascorbic acid (standard group) for patients preparing for outpatient colonoscopy. METHODS: This phase III, multicentre, single-blind, noninferiority, randomised, controlled, trial has not yet been completed. Patients aged 40-69 years will be included as participants. Patients with a history of abdominal or pelvic surgery, constipation, inflammatory bowel disease, or severe organ dysfunction will be excluded. The target number of research participants is 540 (standard group, 270 cases; test group, 270 cases). The primary endpoint is the degree of bowel cleansing (Boston Bowel Preparation Scale [BBPS] score ≥ 6). The secondary endpoints are patient acceptability, adverse events, polyp/adenoma detection rate, number of polyps/adenomas detected, degree of bowel cleansing according to the BBPS (BBPS score ≥ 8), degree of bowel cleansing according to the Aronchik scale, and bowel cleansing time. DISCUSSION: This trial aims to develop a "patient-first" colon cleansing regimen without the risk of inadequate bowel preparation by using both elobixibat hydrate and SP/MC. TRIAL REGISTRATION: Japan Registry of Clinical Trials (jRCT; no. s041210067; 9 September 2021; https://jrct.niph.go.jp/ ), protocol version 1.5 (May 1, 2023).

Photobiomodulation in the Treatment of Dysgeusia in Patients with Long COVID: A Single-Blind, Randomized Controlled Trial.

Objective: The aim of this study is to evaluate local and systemic photobiomodulation (PBM) in patients with COVID-19-related dysgeusia, with the expectation of improving taste dysfunction. Background: PBM has garnered attention as a potential therapy in long COVID, a condition characterized by many persistent symptoms following the acute phase of COVID-19. Among these symptoms, dysgeusia, or altered taste perception, can significantly affect patients' quality of life. Emerging research suggests that PBM may hold promise in ameliorating dysgeusia by modulating cellular processes and reducing inflammation. Further clinical studies and randomized controlled trials are essential to establish the efficacy and safety of PBM for the treatment of dysgeusia in long COVID, but initial evidence suggests that this noninvasive modality may offer a novel avenue for symptom management. Methods: Seventy patients experiencing dysgeusia were randomly assigned to receive active local and systemic PBM (n = 34) or simulated PBM (n = 36). Low-power laser (red wavelength) was used at 18 spots on the lateral borders of the tongue (3 J per spot), salivary glands (parotid, sublingual, and submandibular glands-3 J per spot), and over the carotid artery for 10 min (60 J). Alongside laser therapy, all patients in both groups received weekly olfactory therapy for up to 8 weeks. Results: Dysgeusia improved in both groups. At weeks 7 and 8, improvement scores were significantly higher in the PBM group than in the sham group (p = 0.048). Conclusions: Combined local and systemic PBM, as applied in this study, proved effective and could serve as a viable treatment option for alleviating dysgeusia in long-COVID patients. Clinical Trial Registration: RBR-2mfbkkk.

Efficacy of 660 nm Photobiomodulation in Burning Mouth Syndrome Management: A Single-Blind Quasi-Experimental Controlled Clinical Trial.

Background: Burning mouth syndrome (BMS) is characterized by a burning sensation of the oral mucosa without any evidence of clinical signs or underlining condition. Several treatment modalities have been utilized with various results and levels of evidence. Lately, photobiomodulation (PBM) has emerged as a noninvasive effective therapy due to its anti-inflammatory and biostimulatory effects, especially the low-power laser setting of red wavelength. Objective: This single-blind quasi-experimental controlled clinical trial aimed to evaluate the PBM effectiveness at a low level of red laser light in patients with BMS compared with sham control. Materials and methods: Thirty patients diagnosed with BMS were consecutively assigned to intervention (PBM therapy) and control (sham) groups. The protocol for PBM dosimetry was as follows: laser 660 nm; spot size: 0.04 cm2; power output: 100 mW; emission mode: continuous wave; power density: 6 J/cm2; irradiation time: 10 sec per point within 1 cm2 surface area of the symptomatic area. The treatment protocol was based on once a week for a total of 10 sessions. Results: Our results showed no statistically significant difference in reduction of pain intensity between the two groups at all the evaluated timepoints during the course of treatment. However, in both groups, we observed a statistically significant reduction of maximum pain intensity of 50% compared with patient-self reporting before the treatment. Conclusions: Further randomized clinical trials to validate our positive results with a large sample size with a long-term follow-up and understanding further the sham placebo effect are warranted.

Effects of light therapy on sleep and circadian rhythm in older type 2 diabetics living in long-term care facilities: a randomized controlled trial.

Background: Light influences the secretion of melatonin in the body and regulates circadian rhythms, which play an important role in sleep and mood. The light level of rooms in long-term care facilities is usually far below the threshold required to regulate the body's circadian rhythm, and insufficient light can easily lead to sleep and mood disturbances among older residents in nursing homes. Therefore, the objective of this study was to investigate the effects of light therapy on sleep and circadian rhythm in older adults with type 2 diabetes residing in long-term care facilities. Methods: This study was a prospective, single-blind, randomized controlled trial. Participants were randomly assigned to either the light therapy (LT) group or the control group and received the intervention for four weeks. Primary outcomes included the Pittsburgh Sleep Quality Index (PSQI) and objective sleep parameters recorded by a sleep monitoring bracelet, Morningness-Eveningness Questionnaire (MEQ). The secondary outcome included glycated serum protein (GSP). Data was collected at three time points: at baseline (T0), immediate post-treatment (T1), and 4-week follow-up (T2). A linear mixed model analysis was used to analyzed the data. Results: We enrolled 45 long-term care residents. Compared with the control group, significant reductions in PSQI scores were observed at T1 and T2. At T2, the sleep score of objective sleep parameters was significantly higher in the LT group compared to the control group. Additionally, compared to the baseline T0, MEQ scores were significantly lower in the LT group at T1 and T2, with no significant difference in the control group. There was no significant difference between groups in glycated serum protein values at T1 and T2. However, compared to T0, glycated serum protein values decreased in the LT group while increased in the control group at T2. Conclusion: Light therapy had a positive effect on subjective sleep quality and circadian rhythm time type in long-term care residents with type 2 diabetes, and had a possible delayed effect on objective sleep. However, no discernible alterations in blood glucose levels were detected in this study.

Comparing the effects of positional versus myofascial release of gluteus medius to manage patellofemoral pain syndrome: single blinded randomized clinical trial.

OBJECTIVE: To determine the effects of positional release technique in comparison to myofascial release technique on gluteus medius trigger point along with exercises to manage patellofemoral pain syndrome. METHODS: The single-blind, two-arm, randomised clinical trial was conducted at the Department of Physiotherapy, Sindh Institute of Physical Medicine, Karachi, from December 7, 2020, to March 24, 2021, and comprised patellofemoral pain syndrome of either gender with gluteus medius trigger point. They were randomly allocated to positional release technique group A and myofascial release technique group B. The intervention comprised 3 sessions per week for 6 weeks for a total of 18 sessions, with each session lasting 45 minutes. Function through anterior knee pain scale, pain through visual analogue scale, strength via hand-held dynamometer, and quality of life via World Health Organisation quality of life brief questionnaire were assessed alongside pressure pain threshold via algometer which was taken as the gluteus medius trigger point. All measurements were taken at baseline and 6 week post-intervention. Data was analysed using SPSS 21. RESULTS: Of the 64 participants, 38(59.4%) were females and 26(40.6%) were males. There were 32(50%) subjects in group A with mean age 29.50±5.84 years and 32(50%) in group B with mean age 29.50±5.43 years (p>0.05). Both the groups showed a significant reduction in pain, improvement in function, pressure pain threshold, strength, and quality of life (p;lt;0.05). Intergroup comparisons revealed no significant differences (p>0.05). CONCLUSIONS: Treating myofascial trigger points of gluteus medius muscle, using either positional release technique or myofascial release technique together with exercise therapy was found to be equally beneficial. Clinical Trial gov ID: NCT04667091.

Ketone Supplementation Dampens Subjective and Objective Responses to Alcohol: Evidence From a Preclinical Rat Study and a Randomized, Cross-Over Trial in Healthy Volunteers.

BACKGROUND: Previous preclinical and human studies have shown that a high-fat ketogenic diet and ketone supplements (KS) are efficacious in reducing alcohol craving, alcohol consumption, and signs of alcohol withdrawal. However, the effects of KS on alcohol sensitivity are unknown. METHODS: In this single-blind, cross-over study, 10 healthy participants (3 females) were administered a single, oral dose of a KS (25 g of ketones from D-ß-hydroxybutyric acid and R-1,3-butanediol) or placebo 30 minutes before an oral alcohol dose (0.25 g/kg for women; 0.31 g/kg for men). Assessments of breath alcohol concentration and blood alcohol levels (BAL) and responses on the Drug Effect Questionnaire were repeatedly obtained over 180 minutes after alcohol consumption. In a parallel preclinical study, 8 Wistar rats (4 females) received an oral gavage of KS (0.42 g ketones/kg), water, or the sweetener allulose (0.58 g/kg) followed 15 minutes later by an oral alcohol dose (0.8 g/kg). BAL was monitored for 240 minutes after alcohol exposure. RESULTS: In humans, the intake of KS before alcohol significantly blunted breath alcohol concentration and BAL, reduced ratings of alcohol liking and wanting more, and increased disliking for alcohol. In rats, KS reduced BAL more than either allulose or water. CONCLUSION: KS altered physiological and subjective responses to alcohol in both humans and rats, and the effects were likely not mediated by the sweetener allulose present in the KS drink. Therefore, KS could potentially reduce the intoxicating effects of alcohol.

Effects of a home-based exercise combined yoga and resistance training in enthesitis-related arthritis in China: study protocol for a randomised controlled trial.

INTRODUCTION: Enthesitis-related arthritis (ERA) is a category of juvenile idiopathic arthritis (JIA). The complications of JIA include pain, muscle weakness, limited movement and worsening quality of life. Yoga is an effective exercise therapy for rheumatoid arthritis and may have similar benefits for JIA. Considering the limitation of yoga for strengthening muscles, combined yoga and resistance training (CYRT) may compensate for the shortcomings and provide more benefits for JIA patients. Despite this, there is currently a lack of studies investigating the effectiveness of CYRT for JIA patients. Due to the inaccessibility of traditional exercise therapy, home-based exercise is needed. The study aims to assess the effectiveness of home-based CYRT on JIA. METHODS AND ANALYSIS: This is a 12-week randomised single-blind controlled trial study. 60 patients with ERA will be randomised into two groups: the home-based exercise group (HBE) and the health education (HE) group. The HBE group (n=30) will perform the CYRT programme 3 times a week at home for 12 weeks and receive HE. The HE group (n=30) will only receive HE. The outcomes include primary outcome (pain levels) and secondary outcomes (lower limb muscle strength, motion range of joint, aerobic fitness, function ability, fatigue levels, mental health, quality of life and blood biomarkers). The assessments will be conducted at baseline, postintervention (12 weeks) and follow-up (24 weeks). Data will be analysed by intention to treat. ETHICS AND DISSEMINATION: This study has been approved by the Ethics Committee of Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine in December 2023 (approval no. XHEC-C-2023-059-3). This study will require informed consent from all subjects and guardians of children under 18 years of age. The findings will be published in a peer-reviewed journal and international conferences. TRIAL REGISTRATION NUMBER: ChiCTR2300073446.

Comparative efficacy of 2% minoxidil alone against combination of 2% minoxidil and low-level laser therapy in female pattern hair loss-A randomized controlled trial in Chinese females.

OBJECTIVES: To investigate the effectiveness and safety of combination of 655 nm low level laser helmet device with topical 2 % minoxidil solution at FPHL in Chinese population. MATERIALS AND METHODS: Randomized, parallel, controlled, single-blind clinical trial was conducted. FPHL subjects were randomly allocated into 2 % minoxidil group and combination group. The 2 % minoxidil group received 1 ml topical 2 % minoxidil solution twice daily for 24 weeks. The combination group received 1 ml topical 2 % minoxidil solution twice daily together with 20 min 655 nm low-level laser helmet once every other day for 24 weeks. Hair parameters in two scalp areas including midscalp and vertex were evaluated at baseline, 12th week and 24th week. RESULTS: In midscalp area, the combination group showed a lower increase in intermediate hair percentage than 2 % minoxidil group, which was statistically significant. Besides, the combination group had statistically significant increase than 2 % minoxidil group in mean hair diameter. Reported relative adverse events included slightly hair loss (27.8 %), desquamation (19.0 %), pruritus (15.2 %), seborrhea (2.5 %) and hypertrichosis (2.5 %). CONCLUSION: In our trial, LLLT was demonstrated as a useful supplementary treatment for FPHL and the combination with 2 % minoxidil accomplished better improvement in intermediate hair enlargement and hair diameter of midscalp for FPHL.

The effect of structured supportive approach based on Kolcaba's comfort theory applied to parents of children with cerebral palsy on child's comfort, quality of life, and parent's self-efficacy: A randomised controlled trial.

AIM: This study aims to assess how a structured supportive approach applied to the parents of children living with cerebral palsy according to how the Theory of Comfort affects the child's comfort, quality of life, and parent's self-efficacy. DESIGN: A single-blind, randomised, controlled experimental trial. METHODS: The study was conducted with parents of children with cerebral palsy aged between 8 and 16 years who presented to the rehabilitation centers between October 2021 and November 2022. The sample consisted of a total of 73 parents from the experimental (n = 35) and control (n = 38) groups. While a care programme based on the Theory of Comfort was applied to the intervention group, the practises included in the routines of the centres were applied to the control group. The researcher collected data using the Comfort Behaviours Checklist (CBCL), the Parent Form of the Quality-of-Life Scale for Children (QoLC), and the Self-Efficacy Scale. RESULTS: The children in the intervention group had significantly higher CBCL and QoLC mean scores and the parents in the intervention group had significantly higher self-efficacy mean scores of parents when compared to the control group. CONCLUSIONS: The structured supportive approach based on the Theory of Comfort enhanced children's comfort and quality of life and increased parents' self-efficacy. RELEVANCE TO CLINICAL PRACTICE: It is recommended to implement the structured supportive approach applied according to the Theory of Comfort with the parents of children with cerebral palsy in special training and rehabilitation centres. Paediatric nurses can perform preventive and rehabilitative nursing management with a holistic approach to meet the needs of children with cerebral palsy and their families.

Effects of lavender essential oil inhalation aromatherapy on depression and sleep quality in stroke patients: A single-blind randomized controlled trial.

BACKGROUND AND PURPOSE: Post-stroke depression (PSD) has major implications for rehabilitation, motor recovery, activities of daily living, social and interpersonal functioning, and mortality. In view of the side effects of antidepressants, aromatherapy, a widely used non-pharmacological therapy, has received growing attention in recent years for its benefits of reduced complications, accessibility, and effectiveness. This study was designed to assess the effects of inhalation aromatherapy with lavender essential oil on depression and sleep quality in patients with PSD. MATERIALS AND METHODS: Forty patients with PSD were enrolled and randomized into experimental and placebo groups. Experimental-group patients inhaled microencapsulated lavender essential oil every night at bedtime over a period of 4 weeks. A nonwoven bag containing 2.3 g of microcapsules with about 1.5 g of lavender essential oil was placed on or under the patient's pillow, depending on the patient's scent sensitivity. Placebo-group patients used the empty nonwoven bags for the same period as the experimental group. The 17-item Hamilton Rating Scale for Depression (HAMD-17), the Zung Self-Rating Depression Scale (SDS), and the Pittsburgh Sleep Quality Index (PSQI) were used to measure outcomes. RESULTS: The HAMD-17 score, SDS score, and PSQI score showed statistically significant differences between both groups before and after intervention (P ≤ 0.01). The improvement in the experimental group was more marked than in the placebo group (P < 0.05). CONCLUSION: Lavender essential oil inhalation aromatherapy may help reduce depression and improve sleep quality in patients with PSD.

The PD-Ballet study: study protocol for a randomised controlled single-blind hybrid type 2 clinical trial evaluating the effects of ballet dancing on motor and non-motor symptoms in Parkinson's disease.

BACKGROUND: To date, beneficial effects of multimodal exercise programmes on Parkinson's disease (PD) have focused on motor symptoms and little attention has been paid to the potential effects of such programmes on the non-motor symptoms of PD, which are now universally known as one of the key drivers of quality of life and a key unmet need. We aim to explore clinical effectiveness of a ballet-based dance programme in addressing non-motor and motor symptoms of Parkinson's disease across all stages of progression. METHODS: A randomised, single-blind, controlled trial of 160 people with Parkinson's across all motor stages (Participants will be stratified into three groups of motor advancement: Hoehn and Yahr (HY) stages I and II being Mild Group, HY Stage III being Moderate Group and HY Stages IV and V being Severe Group) will be randomly allocated to either an intervention or a control group using an independent randomisation body. The primary outcome is an improvement in non-motor symptoms as measured by the Movement Disorders Society Non-Motor Scale (MDS-NMS). The intervention protocol consists of 12 one-weekly dance sessions led by English National Ballet. Each session is followed by a 'tea and biscuit' social time. Control group follows standard clinical pathway and joins the 'tea and biscuit' to control for any positive effects of social interactions. All participants are assessed at baseline, immediately after completion of the intervention and 3-6 months later to explore any potential longitudinal effects. DISCUSSION: To our knowledge, no adequately powered study has explored the effects of a dance-based intervention on non-motor symptoms of Parkinson's disease, assessing these on both holistic and granular levels. We also aim to stratify participants in accordance with their motor state as assessed by. HY staging to explore specific effects on the symptoms at the initial, moderate and complex stages of the disease. If successful, this trial provides first evidence on clinical effectiveness of a ballet-based dance intervention for symptoms of Parkinson's disease, assessed in a robust, rigorous manner. TRIAL REGISTRATION: NCT04719468.

Can curcumin supplementation break the vicious cycle of inflammation, oxidative stress, and uremia in patients undergoing peritoneal dialysis?

BACKGROUND & AIMS: Turmeric (a source of curcumin) is an excellent food to modulate oxidative stress, inflammation, and gut dysbiosis in patients with chronic kidney disease (CKD). However, no studies report the benefits of curcumin in patients undergoing peritoneal dialysis (PD). This study aims to evaluate the effects of curcuminoid supplementation on oxidative stress, inflammatory markers, and uremic toxins originating from gut microbiota in patients with CKD undergoing PD. METHODS: This longitudinal, randomized, single-blind, placebo-controlled trial evaluated 48 patients who were randomized into two groups: Curcumin (three capsules of 500 mg of Curcuma longa extract, with 98.42 % total curcuminoids) or placebo (three capsules of 500 mg of starch) for twelve weeks. In the peripheral blood mononuclear cells (PBMCs), the transcriptional expression levels of Nrf2, HOX-1 and NF-κB were evaluated by quantitative real-time PCR. Oxidative stress was evaluated by malondialdehyde (MDA) and total Thiol (T-SH). TNF-α and IL-6 plasma levels were measured by ELISA. P-cresyl sulphate plasma level, a uremic toxin, was evaluated by high-performance liquid chromatography (HPLC) with fluorescent detection. RESULTS: Twenty-four patients finished the study: 10 in the curcumin group (57.5 ± 11.6 years) and 14 in the placebo group (56.5 ± 10.0 years). The plasma levels of MDA were reduced after 12 weeks in the curcumin group (p = 0.01), while the placebo group remained unchanged. However, regarding the difference between the groups at the endpoint, no change was observed in MDA. Still, there was a trend to reduce the p-CS plasma levels in the curcumin group compared to the placebo group (p = 0.07). Likewise, the concentrations of protein thiols, mRNA expression of Nrf2, HOX-1, NF-κB, and cytokines plasma levels did not show significant changes. CONCLUSION: Curcuminoid supplementation for twelve weeks attenuates lipid peroxidation and might reduce uremic toxin in patients with CKD undergoing PD. This study was registered on Clinicaltrials.gov as NCT04413266.

Successful learning of alpha up-regulation through neurofeedback training modulates sustained attention.

As a fundamental attention function, sustained attention plays a critical role in general cognitive abilities and is closely linked to EEG alpha oscillations. Neurofeedback training (NFT) of alpha activity on different aspects of attention has been studied previously. However, it remains unclear how NFT with up- or down-regulation directions modulates sustained attention. Here we employed a counterbalanced single-blind sham-controlled crossover design, in which healthy young adults underwent one NFT session of alpha up-regulation, one NFT session of alpha down-regulation, and one sham-control NFT session over the posterior area. The session order was counterbalanced with a 7-day interval between each session. After each NFT session, the participants completed a visual continuous temporal expectancy task (vCTET) to assess their sustained attention performance. The results showed that compared to sham-control NFT, successful learning of alpha up-regulation resulted in increased reaction time at the beginning of the attention task but a slower increase over vCTET blocks. On the other hand, successful learning of alpha down-regulation had no impact on attention performance compared to sham-control NFT. These findings suggest that successful learning of alpha up-regulation through NFT could impair initial attention performance but slow down visual attention deterioration over time, i.e., alpha enhancement by NFT stabilizing visual attention.

Evaluation of the efficiency of nanomicellar formulation of fat-soluble vitamins in patients with cystic fibrosis: the study protocol for a randomized controlled trial.

BACKGROUND: Cystic fibrosis is an inherited disease, which is caused by the CFTR protein defects due to mutations in the CFTR gene. Along with CFTR dysfunction, exocrine pancreatic insufficiency plays a key role in persistent fat malabsorption in CF patients; therefore, deficiency of fat-soluble vitamins (A, D, E, and K) is still a therapeutic challenge. Even with efficient pancreatic enzyme medication and CF-specific vitamins, many patients with CF have fat-soluble vitamins deficiency. The present study aims to evaluate the efficiency of nanomicelle formulation of fat-soluble vitamins in children with CF in order to achieve the appropriate serum levels of these vitamins. METHODS: This prospective, single-blind control trial will be conducted at the Akbar Children's Hospital in Mashhad, Iran. Patients with CF will be enrolled based on the eligibility criteria. The control group will receive the standard formulation of fat-soluble vitamins similar to the routine CF treatment, and for the intervention group, the nanomicelle formulation of fat-soluble vitamins will be administered for 3 months. The primary outcome of this study is the measurement of serum levels of fat-soluble vitamins. The secondary outcomes are clinical assessment by the Shwachman-Kulczycki score, anthropometrics, and quality of life. Outcomes will be assessed before and after 3 months. DISCUSSION: Due to persistent fat-soluble vitamin deficiency in CF disease, the nanomicelle formulation could be proposed as a new delivery method of fat-soluble vitamins in the treatment of cystic fibrosis. TRIAL REGISTRATION: Iranian Registry of Clinical Trials IRCT20220415054541N1. Registered on July 23, 2022.

Caffeine supplementation improves the cognitive abilities and shooting performance of elite e-sports players: a crossover trial.

We explored the effect of 3 mg/kg of caffeine supplementation on the cognitive ability and shooting performance of elite e-sports players. Nine e-sports players who had received professional training in e-sports and had won at least eighth place in national-level e-sports shooting competitions. After performing three to five familiarization tests, we employed a single blind, randomized crossover design to divide participants into caffeine trial (CAF) and placebo trial (PL). The CAF trial took capsules with 3 mg/kg of caffeine, whereas the PL trial took a placebo capsule. After a one-hour rest, the Stroop task, the visual search ability test, and the shooting ability test were conducted. The CAF trial's performance in the Stroop task in terms of congruent condition (P = 0.023) and visual search reaction time with 20 items (P = 0.004) was significantly superior to those of the PL trial. In the shooting test, the CAF trial's kill ratio (P = 0.020) and hit accuracy (P = 0.008) were significantly higher, and the average time to target (P = 0.001) was significantly shorter than those of the PL trial. Caffeine supplementation significantly improves e-sports players' reaction times and shooting performance.