Large-scale Randomized Controlled Trials Research Articles

Health coaching intervention with or without the support of an exercise buddy to increase physical activity of people with chronic low back pain compared to usual care: a feasibility and pilot randomised controlled trial

BackgroundExercise buddies (people to exercise together with) might support people with low back pain (LBP) to become active. However, involving buddies in randomised controlled trials (RCT) might challenge recruitment, data collection and follow-up. ObjectivesTo explore the feasibility of the intervention, recruitment and data collection approaches and potential effects of a health coaching intervention (focused on physical activity) with or without exercise buddies’ support on physical activity of people with chronic LBP versus usual discharge care. DesignFeasibility and pilot RCT. MethodsAdults (n = 30) discharged from LBP treatment were randomised to the Buddy-Assisted (health coaching intervention with exercise buddy's support), Individual-Only (health coaching only), or usual care groups. Data were collected at baseline, three and six months. The feasibility of trial's procedures was assessed through recruitment rate (acceptable if >70%), data completion rate (acceptable if ≤ 20% missing data), and follow-up rate (successful if ≥ 85%). The intervention's acceptability was assessed via feedback questionnaires. Preliminary effects on physical activity and other outcomes were also explored. ResultsRecruitment and baseline data completion were acceptable. However, data collection and follow-up rates post-randomisation were not. 85% of the Buddy-Assisted Group believed the buddies helped them to increase physical activity and would recommend the intervention. 70% of the Individual-Only and Control groups believed exercise buddies would help them to become further active. ConclusionThe data collection and follow-up approaches were not successful and need amending before a large-scale RCT. Nonetheless, the buddy-assisted intervention was well-accepted. A future RCT will focus on differences in clinical outcomes. Trial registrationThe study was registered at the Australian New Zealand Clinical Trial Registry (ACTRN12620001118998).

Efficacy of Angiotensin Receptor-Neprilysin Inhibitor and Its Renal Outcome in Heart Failure Patients: A Systematic Review of Randomized Clinical Trials.

Heart failure (HF) is a major cause of morbidity and mortality and imposes a significant financial burden on healthcare systems globally. Angiotensin receptor-neprilysin inhibitor (ARNI), a novel neuroendocrine inhibitor, is frequently used in treating HF. However, there is still limited understanding regarding how it compares to other neuroendocrine inhibitors, such as angiotensin-converting enzyme inhibitors (ACEis) and angiotensin receptor blockers (ARBs). The purpose of this research is to present the most recent data regarding the efficacy and renal impact of ARNIs in the treatment of HF in comparison to ACE inhibitors and ARBs. Several large-scale randomized controlled trials (RCTs) have recently been conducted to evaluate the benefits of this drug in patients with different types of HF, regardless of their renal status. We searched multiple databases, including PubMed, PubMed Central (PMC), and Google Scholar, to find relevant RCTs. The efficacy outcome was a composite of the rate of death from cardiovascular causes, the frequency of HF hospitalizations (HFH), and alterations in N-terminal pro-brain natriuretic peptide (NT-proBNP) levels. The renal outcome was impairment of renal function. This systematic review analyzed large-scale RCTs involving 17,327 participants, with an average follow-up time of approximately 2.9 years. sacubitril/valsartan showed notable improvements compared to ACEis and ARBs in the following areas: reduction in NT-proBNP levels, prevention of further deterioration in renal function, and decreased hospitalizations for HF. Interestingly, there is no increased risk of mortality from cardiovascular causes with sacubitril or valsartan.

The efficacy of gastric aspiration in reducing postoperative vomiting after oral and maxillofacial surgery: A meta-analysis.

Gastric aspiration is applied in oral and maxillofacial procedures to reduce postoperative vomiting (POV), yet its clinical benefit remains largely uncertain. Our study aimed to determine the role of gastric aspiration in the amelioration of POV by a meta-analysis. With adherence to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, global recognized databases, including PubMed, Embase, and Cochrane Central, were searched to obtain randomized controlled trials (RCTs) investigating the effects of gastric aspiration in oral and maxillofacial surgery. The incidence and the number of episodes of POV and the frequency of rescue antiemetic use were extracted as parametric data for pooled estimation. Funnel plots and Egger's test were utilized to assess bias. The recommendation of evidence was rated by the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system. After detailed evaluation, 5 RCTs containing 274 participants were eventually included. The results of pooled estimation indicated that gastric aspiration could not reduce the incidence of POV (risk ratio [95% CI] = 0.94 [0.73, 1.21], P = .621), the number of episodes of POV (standard mean difference [95% CI] = -0.13 [-0.45, 0.19], P = .431) or the frequency of rescue antiemetic use (RR [95% CI] = 0.86 [0.49, 1.52], P = .609). No publication bias was detected by the funnel plot and Egger test. The overall recommendation of evidence was rated low regarding each outcome. Based on current evidence, gastric aspiration is not recommended for oral and maxillofacial surgery. Meanwhile, more large-scale high-quality RCTs are needed.

Transcutaneous auricular vagus nerve stimulation for the treatment of myoarthropatic symptoms in patients with craniomandibular dysfunction – a protocol for a randomized and controlled pilot trial

BackgroundTemporomandibular disorders (TMD) are a collective term for pain and dysfunction of the masticatory muscles and the temporomandibular joints. The most common types of TMD are pain-related, which may impact the psychological behavior and quality of life. Currently, the most popular methods for the treatment of TMD patients are occlusal splint therapy, often in combination with physical- and/or pharmacotherapy. However, due to the complexity of etiology, the treatment of chronic TMD remains a challenge. Recently, CE-certified systems for non-invasive VNS (transcutaneous auricular vagus nerve stimulation, taVNS) have become available and show positive effects in the treatment of chronic pain conditions, like migraine or fibromyalgia, with which TMD shares similarities. Therefore, it is the main purpose of the study to evaluate the feasibility of daily taVNS against chronic TMD and to assess whether there is an improvement in pain severity, quality of life, and kinetic parameters.MethodsThis study is designed as a single-blinded, double-arm randomized controlled trial (RCT) in a 1:1 allocation ratio. Twenty adult patients with chronical TMD symptoms will be enrolled and randomized to stimulation or sham group. In the stimulation group, taVNS is performed on the left tragus (25 Hz, pulse width 250 µs, 28 s on/32 s off, 4 h/day). The sham group will receive no stimulation via a non-functional identical-looking electrode. Validated questionnaire data and clinical parameters will be collected at the beginning of the study and after 4 and 8 weeks. The compliance of a daily taVNS of patients with chronical TMD will be evaluated via a smartphone app recording daily stimulation time and average intensity. Additionally, the treatment impact on pain severity and quality of life will be assessed with different questionnaires, and the effect on the mandibular mobility and muscle activity will be analyzed.DiscussionThis is the first clinical trial to assess the feasibility of taVNS in patients with chronic TMD symptoms. If taVNS improves the symptoms of TMD, it will be a significant gain in quality of life for these chronic pain patients. The results of this pilot study will help to determine the feasibility of a large-scale RCT.Trial registrationThis study has been registered in the DRKS database (DRKS00029724).

Using worked examples to promote explanations of fractions concepts: A formative pilot study

This pilot study examined the feasibility of using worked examples as a mechanism to improve verbal explanations of fractions concepts among Grade 5 students with mathematics difficulties in a small-scale randomized controlled trial (RCT) before scaling up to a large-scale RCT. Students ( N = 49) were randomly assigned to a business-as-usual (BAU) comparison group and to two variants of intervention. One intervention condition received both correct and incorrect worked example solutions, the other received correct solutions only. On a measure of verbal explanations, intervention students significantly outperformed students in BAU. Furthermore, students who received both correct and incorrect solutions significantly outperformed students who received correct solutions only on verbal explanations. On fractions proficiency outcomes, results were not significant between intervention and BAU or between the two intervention groups; however, positive findings demonstrate promise for using worked examples to elicit and develop students’ verbal explanations of fractions concepts.

Interventions for Reduction of Stigma in People with Schizophrenia: A Systematic Review and Meta-analysis

People with schizophrenia experienced a higher level of internalized stigma compared to people with other mental disorders. Internalized stigma could lead to pervasive negative effects in their life. Although internalized stigma interventions have shown some benefits, there is a dearth of interventions and meanwhile a lack of evidence as to their effectiveness in people with schizophrenia. This study aims at examining the effectiveness of internalized stigma reduction in people with schizophrenia through a systematic review and meta-analysis. Two electronic databases were searched. Studies were included if they (1) involved community or hospital-based interventions on internalized stigma, (2) included participants who were given a diagnosis of schizophrenia, and (3) were empirical and quantitative in nature. Thirteen articles were selected for extensive review and seven for meta-analysis. A variety of psychosocial interventions were utilized with the majority employing psychoeducation, cognitive behavioral therapy (CBT), social skills training, hope instillation program, and against stigma program. The internalized stigma was used to examine the efficacy of the intervention. Seven studies involving a total of 799 patients were included in the meta-analysis. Assuming a random effects model, the meta-analysis revealed an improvement in internalized stigma favoring the internalized stigma intervention (95% confidence interval [0.492; 1754], P = 0.001), but the heterogeneity among individual effect sizes was substantial (I 2 = 93.20%). Most internalized stigma reduction programs appear to be effective. This systematic review was unable to show light in indicating the most effective intervention, however, demonstrates evidence that psychoeducation is promising. Large-scale randomized control trials and multicomponents of intervention are required to further develop the evidence based of more targeted interventions.

Mindfulness-based Interventions for Chronic Low Back Pain: A Systematic Review and Meta-analysis.

This systematic review aimed to compile existing evidence examining the effects of mindfulness-based interventions (MBIs) for chronic low back pain (CLBP). CLBP leads to millions of disabled individuals in the United States each year. Current pharmacologic treatments are only modestly effective and may present long-term safety issues. MBIs, which have an excellent safety profile, have been shown in prior studies to be effective in treating CLBP yet remained underutilized. Ovid/Medline, PubMed, Embase, and the Cochrane Library were searched for randomized controlled trials (RCTs), pilot RCTs, and single-arm studies that explored the effectiveness of MBIs in CLBP. Separate searches were conducted to identify trials that evaluated MBIs in reducing pain intensity in individuals with CLBP. A meta-analysis was then performed using R v3.2.2, Metafor package v 1.9-7. Eighteen studies used validated patient-reported pain outcome measures and were therefore included in the meta-analysis. The MBIs included mindfulness meditation, mindfulness-based stress reduction, mindfulness-based cognitive therapy, mindfulness-oriented recovery enhancement, acceptance and commitment therapy, dialectical behavioral therapy, meditation-cognitive behavioral therapy, mindfulness-based care for chronic pain, self-compassion course, and loving-kindness course. Pain intensity scores were reported using a numerical rating scale (0 to 10) or an equivalent scale. The meta-analysis revealed that MBIs have a beneficial effect on pain intensity with a large-sized effect in adults with CLBP. MBIs seem to be beneficial in reducing pain intensity. Although these results were informative, findings should be carefully interpreted due to the limited data the high variability in study methodologies, small sample sizes, inclusion of studies with high risk of bias, and reliance on pre-post treatment differences with no attention to maintenance of effects. More large-scale RCTs are needed to provide reliable effect size estimates for MBIs in persons with CLBP.

A randomised controlled feasibility trial of intermittent theta burst stimulation with an open longer-term follow-up for young people with persistent anorexia nervosa (RaISE): Study protocol.

We present the protocol of a feasibility randomised controlled trial (RCT) of intermittent theta burst stimulation (iTBS) for young people with anorexia nervosa (AN). Effective first-line psychological therapies exist for young people with AN, but little is known about how to treat those who do not respond. Non-invasive neuromodulation, such as iTBS, could address unmet treatment needs by targeting neurocircuitry associated with the development and/or maintenance of AN. Sixty-six young people (aged 13-30years) with persistent AN will be randomly allocated to receive 20 sessions of real or sham iTBS over the left dorsolateral prefrontal cortex in addition to their usual treatment. Outcomes will be measured at baseline, post-treatment (1-month post-randomisation) and 4-months post-randomisation (when unblinding will occur). Additional open follow-ups will be conducted at 12- and 24-months post-randomisation. The primary feasibility outcome is the proportion of participants retained in the study at 4-months. Secondary outcomes include AN symptomatology, other psychopathology, quality of life, service utilisation, neurocognitive processes, and neuroimaging measures. Findings will inform the development of a future large-scale RCT. They will also provide exploratory data on treatment efficacy, and neural and neurocognitive predictors and correlates of treatment response to iTBS in AN.

Effects of mHealth-Based Lifestyle Interventions on Gestational Diabetes Mellitus in Pregnant Women With Overweight and Obesity: Systematic Review and Meta-Analysis.

The increasing incidence of gestational diabetes mellitus (GDM) is a global health problem that is more likely to occur in pregnant women with overweight or obesity. Adhering to a healthy lifestyle is associated with a reduced risk of GDM. With the development of IT, mobile health (mHealth) interventions have become widely available in health care. However, there are no definitive conclusions on the effectiveness of mHealth-based lifestyle interventions in preventing GDM. This study aims to evaluate the impact of mHealth-based lifestyle interventions on GDM and other pregnancy outcomes in pregnant women with overweight or obesity. A systematic literature search was conducted in 5 English databases (MEDLINE, Embase, Web of Science, CENTRAL, and CINAHL) and 4 Chinese databases (CBM, CNKI, Vip, and Wanfang) to identify randomized controlled trials (RCTs) on the effectiveness of mHealth-based interventions for GDM from inception to January 10, 2023. In total, 2 authors independently screened the studies and extracted the data. The quality of the included studies was examined using the Cochrane risk-of-bias tool. Data synthesis was conducted using Review Manager (version 5.4; The Cochrane Collaboration). A total of 16 RCTs with 7351 participants were included in this study. The included studies were published between 2014 and 2021 and were conducted in China, the United States, Australia, New Zealand, the United Kingdom, Ireland, and Norway. The sample sizes of the studies ranged from 75 to 2202, and the duration of the mHealth-based lifestyle interventions ranged from 4 to 28 weeks. Compared with usual care, mHealth-based lifestyle interventions significantly reduced the incidence of GDM (odds ratio [OR] 0.74, 95% CI 0.56-0.96; P=.03; I2=65%), preterm birth (OR 0.65, 95% CI 0.48-0.87; P=.004; I2=25%), macrosomia (OR 0.59, 95% CI 0.40-0.87; P=.008; I2=59%), and gestational weight gain (mean difference=-1.12 kg, 95% CI -1.44 to -0.80; P<.001; I2=43%). The subgroup analysis showed that interventions delivered via apps (OR 0.55, 95% CI 0.37-0.83; P=.004; I2=44%), provided by obstetricians (OR 0.69, 95% CI 0.51-0.93; P=.02; I2=60%), and targeted at Asian populations (OR 0.44, 95% CI 0.34-0.58; P<.001; I2=0%) and that used the International Association of Diabetes and Pregnancy Study Groups diagnostic criteria (OR 0.58, 95% CI 0.39-0.86; P=.007; I2=69%) showed a statistically significant reduction in the risk of GDM. mHealth-based lifestyle interventions had a favorable impact on the prevention of GDM in pregnant women with overweight and obesity. Future studies need to further explore the potential of mHealth-based interventions for GDM through better design and more rigorous large-scale RCTs. PROSPERO International Prospective Register of Systematic Reviews CRD42021286995; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=286995.

The impact of the Mediterranean diet on alleviating depressive symptoms in adults: a systematic review and meta-analysis of randomized controlled trials.

High adherence to the Mediterranean diet (MD) has been associated with a reduced risk of depression in prospective cohort studies, but whether MD interventions are effective among adults with depression is uncertain. This study aimed to synthesize findings on the effects of MD interventions on the severity of depressive symptoms in adults with depression. PubMed, Cochrane CENTRAL, PsycINFO, Scopus, and Web of Science were systematically searched from database inception to March 2023. The Preferred Reporting Items for Systematic Review and Meta-Analyses guidelines and the Cochrane recommendations were followed. We included randomized controlled trials (RCTs) comparing outcomes after MD interventions with outcomes for control conditions in adults with depressive disorders or depressive symptoms. Two authors extracted the data independently. The Sidik-Jonkman estimator, the I2 metric, and the prediction interval were used to estimate between-study heterogeneity. To determine the risk of bias and the certainty of evidence from RCTs, we used the Cochrane Collaboration's Risk of Bias 2 and Grades of Recommendation, Assessment, Development, and Evaluation tools, respectively. In total, 1507 participants (mean age range: 22.0 years-53.3 years) with depression were initially included in the 5 RCTs of this review. Compared with control conditions, MD interventions significantly reduced depressive symptoms among young and middle-aged adults with major depression or mild to moderate depressive symptoms (standardized mean difference: -0.53; 95% confidence interval: -0.90 to -0.16; I2 = 87.1%). The prediction interval ranged from -1.86 to 0.81. The overall risk of bias was within the range of "some concerns" to "high," while the certainty of evidence was low. MD interventions appear to have substantial potential for alleviating depressive symptoms in people experiencing major or mild depression. However, to establish robust recommendations, there remains a need for high-quality, large-scale, and long-term RCTs. PROSPERO registration no. CRD42022341895.

Evidence-based interventions targeted at behavioral inhibition, shyness, and anxious withdrawal during the preschool years: A rapid review

High and stable behavioral inhibition (BI) during early childhood may place individuals at increased risk of experiencing anxiety during the COVID-19 crisis. Prior knowledge syntheses showed that selective prevention interventions were effective in reducing child BI and anxiety. However, the effectiveness of preschool-based universal and selective prevention interventions targeted at BI to improve child social outcomes remains unclear. Due to the vulnerability of highly inhibited children, this rapid review aimed to (1) synthetize the characteristics of evidence-based interventions targeted at BI, and (2) summarize intervention outcomes in domains of child individual and social functioning. Randomized controlled trials (RCTs), published between january 1991 and december 2021, conducted with highly inhibited children aged 3 to 5 years, were included in the review. Thirteen RCTs on four evidence-based interventions targeted at BI were retained. Most studies were conducted in samples of married/cohabitating and highly educated mothers and almost half of them described parent-only interventions. Three pilot RCTs on child-only and multimodal interventions found significant post-intervention improvements in observed child social competence and positive peer interactions. Pre-to-post intervention changes in parent and teacher ratings on child social outcomes were less consistent across studies. Further large-scale RCTs with medium-to-long term follow-ups are needed to examine intervention outcomes in domains of child social functioning, using a multi-informant and multi-method approach. After the COVID-19 crisis, preschool-based universal interventions targeting BI may enhance the engagement of inhibited children from diverse communities and contribute to the generalization of intervention effects to naturalistic peer settings.

Infectious Diseases and Their Role in Neuroimmune Disease

Recent findings suggest a relationship between a post-infectious immune response and neurologic changes. These changes, manifesting as various neurological symptoms, including memory issues and cognitive alterations, may be linked to a form of post-infectious autoimmunity. We have coined the term “Alzheimer’s of the Immune System,” or AIS, to describe this syndrome and various immune partners that may play a role in this immune dysfunction have been identified. Here, we will discuss several clinical presentations that feed into the hypothesis of infectious-immune axis and its mechanism of action. We propose that these disorders fall under the umbrella of AIS and discuss the role of immuno therapy in their management. First, we consider pediatric acute-onset neuropsychiatric syndrome (PANS), a broad diagnostic criterion created to describe children with severe, sudden onset of neuropsychiatric changes. Research exploring the link between immune dysregulation in PANS and its amelioration with intravenous immunoglobulin treatment strongly suggests the association of PANS with a pro-inflammatory state. Next, we delve into autism spectrum disorder (ASD), characterizing it as a neuroimmune disorder. ASD marked by communication and social skill deficits, as well as repetitive and stereotypical behaviors, is characterized by related but distinct profiles of immune dysregulation, inflammation, and endogenous autoantibodies that persist within the affected individual. Further definition of the role of immune dysregulation in ASD thus necessitates a deeper understanding of the interaction between both the mother’s and child’s immune systems, and their potential role in diagnosis and treatment. Lastly, we discuss post-viral fatigue syndrome in patients who have recovered from SARS-CoV-2 infection as another example of neuroimmune condition recently added to the growing list. Further research is needed to validate our hypothesis of AIS, including large scale randomized control trials of different immuno therapies. By unravelling the infectious-immune axis and its mechanism of action, we equip physicians with valuable tools for identifying optimal forms of treatment and management for these conditions.

Optical coherence tomography-guided vs. intravascular ultrasound-guided percutaneous coronary intervention: a systematic review and meta-analysis of randomized controlled trials.

Optical coherence tomography (OCT) and intravascular ultrasound (IVUS) are superior to coronary angiography for guiding percutaneous coronary intervention (PCI). However, whether one technique is superior to the other is inconclusive. We searched PubMed, Embase, the Cochrane Library, and ClinicalTrials.gov from inception to November 2023 for randomized controlled trials (RCTs) comparing OCT and IVUS in patients undergoing PCI. RevMan 5.4 was used to pool outcomes with risk ratio (RR) as the effect measure. Six RCTs (4,402 patients) were included in this meta-analysis. There was no significant difference between the OCT- and IVUS-guided PCI groups in the risk of major adverse cardiovascular events (RR 0.87, 95% CI: 0.65, 1.16; I2 = 0%) and cardiac mortality (RR 0.73, 95% CI: 0.24, 2.21; I2 = 0%). The results were consistent across the subgroups of the presence or absence of left main disease (P interaction >0.1). There were no significant differences between OCT and IVUS in the risk of target lesion revascularization (RR 0.78, 95% CI: 0.47, 1.30; I2 = 0%), target vessel revascularization (RR 1.06, 95% CI: 0.69, 1.62; I2 = 0%), target-vessel myocardial infarction (RR 0.79, 95% CI: 0.40, 1.53; I2 = 0%), stent thrombosis (RR 0.59, 95% CI: 0.12, 2.97; I2 = 0%), and all-cause mortality (RR 1.01, 95% CI: 0.53, 1.90; I2 = 0%). Our meta-analysis demonstrated similar clinical outcomes in OCT- and IVUS-guided PCI. New large-scale multicenter RCTs with long-term follow-up are required to confirm or refute our findings and provide more reliable results. PROSPERO, identifier, CRD42023486933.

Meta-analysis of randomized controlled trials assessing the efficacy of nigella sativa supplementation for allergic rhinitis treatment.

Demonstrating the positive effects of Nigella sativa supplementation (Nigella spp) on Allergic Rhinitis (AR) treatment is challenging. To investigate the role of Nigella spp in managing AR, a comprehensive review through systematic reviews and meta-analyses was conducted. To carry out a meta-analysis of clinical trials that used Nigella spp in treating AR based on current data. A meta-analysis of randomized controlled trials (RCTs) was performed. Various databases, including PubMed, Web of Science, Embase, Science Direct, Springer Link and the Cochrane Library, were searched until October 2023 to obtain RCTs assessing impact of Nigella spp in the control of AR. The current meta-analysis was carried out with a random-effects model. There were 8 studies enrolled, and our meta-analysis findings revealed that, relative to the control group, observation group exhibited the markedly increased total effective rate for allergic rhinitis treatment (odds ratio [OR] = 4.24, 95% confidence interval [CI] (2.57, 7.27), and p < 0.00001); three studies showed that the effect of Nigella spp for nasal symptoms treatment among patients with allergic rhinitis was superior in observation group to control group [mean difference = -2.60, 95% CI (-2.82, -2.38), p < 0.00001]; adverse effects occurred in five studies, all of which were transient, did not require medical intervention, and were not statistically significant between the two groups [OR = 1.01, 95% CI (0.59, 1.73), p = 0.98]. The observation group demonstrated relative safety and had an enhanced effect on allergic rhinitis treatment and total nasal symptom improvement than the control group. The inclusion of fewer studies and the lower quality of trial design might affect the stability of the results. However, the evidence-based findings that Nigella spp for allergic rhinitis treatment is more accurate should be validated in future large-scale, multicenter, and well-designed RCTs.

A feasibility randomized controlled trial of a community-level physical activity strategy for older adults with motoric cognitive risk syndrome.

The motoric cognitive risk syndrome (MCR) is a syndrome characterized by subjective memory complaints and slow walking speeds that can identify older adults at increased risk for developing Alzheimer's disease or a related dementia (ADRD). To date, the feasibility of community-based physical activity (PA) programs for improving outcomes in MCR have yet to be examined. To address this knowledge gap, we conducted a translational randomized controlled trial (RCT) comparing 24-weeks of PA to a healthy aging education (HE) control intervention delivered within the infrastructure of an urban senior center in Greater Boston (clincaltrials.gov identifier: NCT03750682). An existing senior center employee was trained to administer the multimodal group-based PA program that included moderate-intensity aerobic walking, strength, flexibility and balance training. A total of 79 older adults attended the senior center for a screening visit, of whom 29 met the MCR criteria and 25 were randomized to PA or HE (mean age: 74.4 ± 7years; BMI: 32.4 ± 7kg/m2; 85% female; 3MSE score: 92.4 ± 7; gait speed: 0.52 ± 0.1m/s; SPPB score 4.8 ± 1.9). Due to the Covid-19 pandemic the study was stopped prematurely. Participants could successfully adhere to the study interventions (overall attendance rate: PA: 69% vs. HE:70% at study termination). Participants also successfully completed baseline and follow-up study assessments that included a computerized cognitive testing battery and objective tests of physical performance and functional exercise capacity. No study-related adverse events occurred. Notable trends for improved cognitive performance, gait speed and 6-min walk distance were exhibited in PA compared to HE. Our study provides important preliminary information to aid the design of larger-scale RCTs of PA that may help to preserve the independence of vulnerable older adults at high risk for ADRD in community-based settings.

Exploring the Effectiveness of Hatha Yoga as a Complementary Treatment for Adolescent Idiopathic Scoliosis: Clinical Effect and Future Research Directions.

Adolescent idiopathic scoliosis (AIS) is a common spinal deformity that primarily affects adolescents during the key period of growth and development. While traditional treatment methods often involve bracing or surgery, Hatha yoga, a millennia-old practice rooted in Indian tradition, has emerged as a complementary option for AIS cases. This paper explores the potential benefits of Hatha yoga for adolescents with AIS. It also discusses the limitations of existing research, such as the lack of large-scale randomized controlled trials (RCTs), varying yoga protocols, and challenges in blinding participants and researchers. To address these limitations, I propose future research directions, including conducting large-scale RCTs, long-term follow-up studies, standardized yoga protocols, and assessing safety concerns. I also highlight the need for tailored interventions and comparative effectiveness studies to better understand the potential of Hatha yoga in the holistic treatment of AIS in adolescents.

Recent Clinical Research on Acupuncture Therapy for Cluster Headache

Objectives: This study presents evidence by analyzing the research trends in acupuncture treatment for cluster headache in the last 10 years.Methods: Randomized controlled trials (RCTs) about acupuncture for cluster headache were searched from the China National Knowledge Infrastructure, PubMed, Cochrane Library, Oriental Medicine Advanced Searching Integrated System, ScienceON, Korean Studies Information Service System, and Research Information Sharing Service. The search terms were the combinations of “cluster headache”, “acupuncture”, and “needle therapy”, and the articles were restricted to those published between 2013 and 2023. Only RCTs were selected. The risk of bias (RoB) was assessed according to the revised Cochrane RoB2 criteria.Results: Six RCTs were selected and analyzed in this review. All selected studies were conducted in China. All RCTs comprised 628 participants. Manual acupuncture was used in all studies. Acupuncture targeting the sphenopalatine ganglion was performed in two papers published after 2020. ST8, Ex-HIN3, and GB14 were the most frequently used acupoints in acupuncture treatment. The most commonly used indicators for evaluation were headache attack frequency, clinical efficacy, and the visual analog scale. In each study, adding acupuncture treatment to conventional therapy had significant effects in relieving the symptoms of cluster headaches.Conclusion: The results suggest that acupuncture is an effective treatment for cluster headache. To ensure objective evidence for the effectiveness of acupuncture treatment in cluster headache, it is important to continue large-scale case reports and RCTs.

Nigella sativa for the treatment of COVID-19 patients: A rapid systematic review and meta-analysis of randomized controlled trials.

Nigella sativa is an herbal therapy for various afflictions. It has some potential to be a promising option as an efficacious treatment for COVID-19 patients that can contribute to global healthcare as a relatively cheap therapy but evidence of its use from randomized controlled trials (RCTs) is limited. Therefore, to explore the effect of N. sativa in combating COVID-19, we undertook this meta-analysis. We searched several databases to retrieve all RCTs investigating N. sativa for the treatment of COVID-19 as compared to placebo or standard care. We used RevMan 5.4 for all analyses with risk ratio (RR) or odds ratio (OR) as the effect measures. We included a total of seven RCTs in this review. N. sativa significantly reduced the risk of all-cause mortality in patients with COVID-19 compared to the control group (RR 0.27, 95% CI: 0.10 to 0.72; I 2 = 0%). N. sativa significantly reduced the rate of viral PCR positivity (RR 0.62, 95% CI: 0.39 to 0.97; I 2 = 0%). We did not find any significant difference in the risk of hospitalization (RR 0.26, 95% CI: 0.04 to 1.54; I 2 = 0%) and the rate of no recovery (OR 0.48, 95% CI: 0.20 to 1.15; I 2 = 84%) between the two groups. N. sativa is an easily available herbal medicine that may decrease the risk of mortality and improve virological clearance in COVID-19 patients. However, our results are limited by the small number of RCTs available. Further large-scale RCTs are needed to better understand the anti-inflammatory and antiviral effects of N. sativa in COVID-19 patients.

FEASIBILITY OF A COMMUNITY-LEVEL PHYSICAL ACTIVITY STRATEGY FOR OLDER ADULTS WITH MOTORIC COGNITIVE RISK SYNDROME

Abstract The motoric cognitive risk syndrome (MCR) is a pre-dementia syndrome characterized by slow walking speeds and subjective memory complaints. To date, the feasibility of a community-based physical activity (PA) program for improving outcomes in MCR has not been examined. To address this knowledge gap, we conducted a translational randomized controlled trial (RCT) of 24-weeks of PA or a healthy aging education (HE) control intervention delivered within the existing infrastructure of an urban senior center in Greater Boston. A senior center employee was trained to administer the multimodal group-based PA program that included moderate-intensity aerobic walking, strength, flexibility and balance training. A total of 79 older adults attended the senior center for a screening visit of whom 25 met the MCR criteria and were randomized to PA or HE (mean age: 74.4 ± 7 yrs; BMI: 32.4 ± 7 kg/m2; 85% female; 3MSE score: 92.4 ± 7; gait speed: 0.52 ± 0.1 m/sec; SPPB score 4.8 ± 1.9). Due to COVID-19 the study was terminated early, however participants successfully completed baseline and follow-up study assessments that included objective tests of physical function and an iPad-based cognitive testing battery. Participants could appropriately adhere to the study interventions (overall attendance rate: PA: 69.3% vs. HE:70.1% at study termination). No study-related adverse events occurred. Trends for improved executive cognitive performance were exhibited in PA compared to HE. Our study provides important preliminary information to aid the design of larger-scale RCTs to preserve the independence of vulnerable older adults with MCR in community-based settings.

P115: Testing the feasibility of a multicomponent neuropsychological intervention for individuals at-risk of dementia: the REMINDER program

Objective:Interventions aimed to optimize cognitive function and functionality in individuals at risk of dementia were scarce in validity studies. While some RCTs have been developed in cognitive training interventions, studies of multicomponent interventions (cognitive, social, and behavioral) integrating intervention targeting psychosocial risk factors (social isolation, depression, low cognitive reserve) is absent. Additionally, few efforts have been made to develop such validity studies with individuals at higher risk of dementia who still do not present objective cognitive decline, despite current recommendations in this regard. We aimed to start the validation of a 20-session multicomponent intervention – REMINDER program - with a feasibility test and a preliminary efficacy testing using a comprehensive outcome assessment protocol.Methods:A feasibility randomized controlled trial (RCT) was conducted, recruiting community-dwelling individuals between 60 to 75 years old with increased risk of dementia (LIBRA dementia risk score). Fifteen participants took part in twice-a-week sessions of the REMINDER program, during twelve weeks. Data on the acceptability, satisfaction and adherence to the REMINDER program was collected, and an association between pre and post intervention motivation and knowledge about dementia risk was examined. For the preliminary efficacy testing we considered as primary outcome a performance-based functionality measure (UPSA) and secondary outcomes will include global cognition, emotional status, and lifestyle habits, tested prior and after the intervention.Results:Rates of satisfaction throughout the REMINDER program sessions were high (75%, mean) as well as the adherences that was superior to the main dementia risk reduction programs referred in literature. (83%). Post-intervention efficacy testing is ongoing, however, levels of knowledge about dementia risk increased 12% compared with pre-intervention (34% pre-intervention, to 46% post intervention; p=.045)Discussion:Preliminary data on feasibility and efficacy of the REMINDER program suggests this program is an engaging and motivating tool for dementia risk reduction, justifying the future implementation of a large-scale RCT. We expect that, with a larger efficacy study we can demonstrate the REMINDER program effects in behavior change and in the adoption of protective lifestyles for dementia prevention, and that the comprehensive outcome assessment proves to be effective and, therefore, replicable in further studies.