Tablet-based sensorimotor home-training system for amnestic mild cognitive impairments in the elderly: design of a randomised clinical trial

IntroductionDementia (particularly Alzheimer’s disease, AD) is a major cause of impaired cognitive functions in the elderly. Amnestic mild cognitive impairment (aMCI) is a prodromal stage of AD, if substantiated by Alzheimer biomarkers. A neuroscientific model of pathological ageing emphasises the loss of brain plasticity, sensorimotor capacities and subsequent cognitive decline. A mechanistic treatment targeting dysfunctional plastic changes associated with ageing should be efficacious in delaying AD. In this trial, we aim to evaluate the effectiveness of a newly developed sensorimotor training, delivered at home, combined with personalised reinforcement, on the progression of aMCI-related cognitive impairments.Methods and analysisIn a randomised trial, we will compare two aMCI groups (30 subjects each), randomly allocated to a sensorimotor or a cognitive control training. Both trainings consist of an adaptive algorithm, and will last 3 months each. We hypothesise that both trainings will have positive effects on cognitive function with the sensorimotor training being superior compared with the control training based on its improvement in basic perceptual skills underlying memory encoding and retrieval. The primary outcome is episodic memory function, improved hippocampal function during memory tasks will be a secondary outcome. As further exploratory outcomes, we expect improved segregation in sensory and motor maps, better sensory discrimination only in the sensorimotor training and reduced transition to dementia (examined after completion of this study). We expect the experimental training to be evaluated more positively by the users compared with the cognitive training, resulting in reduced rates of discontinuation.Ethics and disseminationThe Ethics Committee of the Medical Faculty Mannheim, Heidelberg University, approved the study (2015–543N-MA), which adheres to the Declaration of Helsinki. The results will be published in a peer-reviewed journal. Access to raw data is available on request.Trial registration numberDRKS00012748.

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A Randomised Clinical Trial to Compare the Effectiveness of Baska Mask Versus i-gel in Patients Undergoing Laparoscopic Surgeries in a Tertiary Centre

Journal of Evidence Based Medicine and Healthcare ◽

10.18410/jebmh/2021/383 ◽

2021 ◽

Vol 8 (24) ◽

pp. 2040-2044

Author(s):

Anil Kumar Mysore Ramakrishna ◽

Sarika Manjunath Shetty ◽

Anup Natha Ramachandragowda ◽

Vyshnavi Sriram ◽

Shali Sohail ◽

...

Keyword(s):

Randomised Trial ◽

Randomised Clinical Trial ◽

Airway Device ◽

Supraglottic Airway ◽

Secondary Outcome ◽

Tertiary Centre ◽

Group I ◽

Supraglottic Airway Devices ◽

Sealing Pressure ◽

The Impact

BACKGROUND A wide array of supraglottic airway devices (SAD) are available for the present day anaesthetic practice, each having its own unique features. Laparoscopic surgeries demand meticulous airway maintenance due to the impact of pneumoperitoneum on cardiorespiratory physiology. It thus becomes imperative to have knowledge about the most optimal SAD that can be used for laparoscopic surgeries to provide good quality anaesthesia. The objective of this randomised trial was to compare the airway sealing pressure (ASP) of Baska mask and i-gel and overall success rate in patients undergoing laparoscopic surgeries under general anaesthesia and controlled ventilation. METHODS One hundred and forty patients undergoing laparoscopic surgeries were randomly assigned to either Baska group (Group B) or i-gel group (Group I). Anaesthesia was induced with propofol 2 - 2.5 milligram per kilogram (mg / kg) and relaxation achieved with vecuronium 0.1 mg / kg and SAD was inserted. The primary outcome was airway sealing pressure (ASP) noted after insertion of the device. The secondary outcome measures included the number of attempts and time taken for successful insertion, ASP after gas insufflation of abdomen, Brimacombe grading, hemodynamic changes, airway morbidity (blood on the SAD upon removal, post-operative sore throat, dysphagia and dysphonia) and any other adverse events associated with the use of the devices. RESULTS There were no significant differences in demographic and hemodynamic data. ASP after insertion of the device was significantly higher (p < 0.0001) with Baska than i-gel (41.45 + 4.72 versus 30.29 + 5.76 cm H2O respectively). Brimacombe scoring of grade four was seen in 75.3 % of Baska compared to 18 % in i-gel group. Time taken to insert Baska was significantly more than with i-gel (14.84 versus 11.25 seconds respectively, P < 0.001). However, first time success was more with Baska than with i-gel (147 versus 140 respectively). CONCLUSIONS Both Baska and i-gel can be used safely and effectively in laparoscopic surgeries. Baska provides a better ASP and Brimacombe view than i-gel. However, i-gel offers the advantage of easier insertion in shorter time. KEYWORDS Supraglottic Airway Device, Baska Mask, i-gel, Airway Sealing Pressure

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BOugie or stylet in patients UnderGoing Intubation Emergently (BOUGIE): protocol and statistical analysis plan for a randomised clinical trial

BMJ Open ◽

10.1136/bmjopen-2020-047790 ◽

2021 ◽

Vol 11 (5) ◽

pp. e047790

Author(s):

Brian Driver ◽

Matthew W Semler ◽

Wesley H Self ◽

Adit A Ginde ◽

Sheetal Gandotra ◽

...

Keyword(s):

Medical Center ◽

Randomised Trial ◽

Randomised Clinical Trial ◽

Orotracheal Intubation ◽

Statistical Analysis Plan ◽

Institutional Review Board ◽

Secondary Outcome ◽

Intubation Attempt ◽

Institutional Review ◽

The Usa

IntroductionIntubation-related complications are less frequent when intubation is successful on the first attempt. The rate of first attempt success in the emergency department (ED) and intensive care unit (ICU) is typically less than 90%. The bougie, a semirigid introducer that can be placed into the trachea to facilitate a Seldinger-like technique of tracheal intubation and is typically reserved for difficult or failed intubations, might improve first attempt success. Evidence supporting its use, however, is from a single academic ED with frequent bougie use. Validation of these findings is needed before widespread implementation.Methods and analysisThe BOugie or stylet in patients Undergoing Intubation Emergently trial is a prospective, multicentre, non-blinded randomised trial being conducted in six EDs and six ICUs in the USA. The trial plans to enrol 1106 critically ill adults undergoing orotracheal intubation. Eligible patients are randomised 1:1 for the use of a bougie or use of an endotracheal tube with stylet for the first intubation attempt. The primary outcome is successful intubation on the first attempt. The secondary outcome is severe hypoxaemia, defined as an oxygen saturation less than 80% between induction until 2 min after completion of intubation. Enrolment began on 29 April 2019 and is expected to be completed in 2021.Ethics and disseminationThe trial protocol was approved with waiver of informed consent by the Central Institutional Review Board at Vanderbilt University Medical Center or the local institutional review board at an enrolling site. The results will be submitted for publication in a peer-reviewed journal and presented at scientific conferences.Trial registration numberClinicalTrials.gov Registry (NCT03928925).

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Fish oil supplemented for 9 months does not improve glycaemic control or insulin sensitivity in subjects with impaired glucose regulation: a parallel randomised controlled trial

British Journal Of Nutrition ◽

10.1017/s0007114515004274 ◽

2015 ◽

Vol 115 (1) ◽

pp. 75-86 ◽

Cited By ~ 13

Author(s):

Louise F. Clark ◽

M. C. Thivierge ◽

Claire A. Kidd ◽

Susan C. McGeoch ◽

Prakash Abraham ◽

...

Keyword(s):

Insulin Sensitivity ◽

Glycaemic Control ◽

Fish Oil ◽

Randomised Trial ◽

Whole Body ◽

Secondary Outcome ◽

Phospholipid Content ◽

Body Protein ◽

Positive Effects ◽

Oil Type

AbstractThe effects of fish oil (FO) supplementation on glycaemic control are unclear, and positive effects may occur only when the phospholipid content of tissue membranes exceeds 14 % asn-3 PUFA. Subjects (n36, thirty-three completed) were paired based on metabolic parameters and allocated into a parallel double-blind randomised trial with one of each pair offered daily either 6 g of FO (3·9 gn-3 PUFA) or 6 g of maize oil (MO) for 9 months. Hyperinsulinaemic–euglycaemic–euaminoacidaemic (HIEGEAA) clamps (with [6,62H2glucose]) were performed at the start and end of the intervention. Endogenous glucose production (EGP) and whole-body protein turnover (WBPT) were each measured after an overnight fast. The primary outcome involved the effect of oil type on insulin sensitivity related to glycaemic control. The secondary outcome involved the effect of oil type on WBPT. Subjects on FO (n16) had increased erythrocyten-3 PUFA concentrations >14 %, whereas subjects on MO (n17) had unalteredn-3 PUFA concentrations at 9 %. Type of oil had no effect on fasting EGP, insulin sensitivity or total glucose disposal during the HIEGEAA clamp. In contrast, under insulin-stimulated conditions, total protein disposal (P=0·007) and endogenous WBPT (P=0·001) were both increased with FO. In an associated pilot study (n4, three completed), althoughn-3 PUFA in erythrocyte membranes increased to >14 % with the FO supplement, the enrichment in muscle membranes remained lower (8 %;P<0·001). In conclusion, long-term supplementation with FO, at amounts near the safety limits set by regulatory authorities in Europe and the USA, did not alter glycaemic control but did have an impact on WBPT.

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Effects of a Group Program to Increase Cognitive Performance Through Cognitively Stimulating Leisure Activities in Healthy Older Subjects

GeroPsych ◽

10.1024/1662-9647/a000035 ◽

2011 ◽

Vol 24 (2) ◽

pp. 83-92 ◽

Cited By ~ 22

Author(s):

Valentina A. Tesky ◽

Christian Thiel ◽

Winfried Banzer ◽

Johannes Pantel

Keyword(s):

Cognitive Function ◽

Cognitive Performance ◽

Older Persons ◽

Intervention Program ◽

Leisure Activities ◽

The Elderly ◽

Cognitive Stimulation ◽

Group Program ◽

Positive Effects ◽

Older Subjects

To investigate the effects of leisure activities on cognitive performance of healthy older subjects, an innovative intervention program was developed. Frequent participation in cognitively stimulating activities (i.e., reading, playing chess, or playing music) is associated with reduced risk of dementia. AKTIVA (active cognitive stimulation – prevention in the elderly) is an intervention program designed to enhance cognitive stimulation in everyday life by increasing cognitive stimulating leisure activities. The present study determines the effects of AKTIVA on cognitive function, mood and attitude toward aging in a sample of older participants from the general population. Several measurement instruments were used including the Alzheimer’s Disease Assessment Scale (ADAS-Cog), the Trail-Making Test (TMT), and the Memory Complaint Questionnaire (MAC-Q). Initially, the sample consisted of 307 older persons (170 female, 72 ± 7 years). The intervention was evaluated with a randomized, controlled pre-post follow-up design. Participants were randomly assigned to one of three conditions: AKTIVA intervention (n = 126), AKTIVA intervention plus nutrition and exercise counseling (n = 84), no-intervention control group (n = 97). The AKTIVA intervention consisted of 8 weekly sessions and two booster sessions after a break of 4 months. Participation in the group program resulted in positive effects on cognitive function and attitude toward aging for subassembly groups. Older persons (≥ 75 years) showed enhanced speed of information processing (by TMT Version A) (F = 4.17*, p < .05); younger participants (< 75 years) showed an improvement in subjective memory decline (by MAC-Q) (F = 2.55*, p < .05). Additionally, AKTIVA enhanced the frequency of activities for leisure activities for subassembly groups. The results of this study suggest that the AKTIVA program can be used to increase cognitively stimulating leisure activities in the elderly. Further research is necessary to identify the long-term effects of this intervention particularly with respect to the prevention of dementia.

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Application of mobile health to support the elderly during the COVID-19 outbreak: A systematic literature review (Preprint)

10.2196/preprints.26929 ◽

2021 ◽

Author(s):

Saeedeh Fehresti ◽

Elham Monaghesh

Keyword(s):

Mental Health ◽

Health Services ◽

Mobile Health ◽

The Elderly ◽

Mental Health Consultation ◽

Inclusion Criteria ◽

Physical And Mental Health ◽

Current Crisis ◽

Health Service Provision ◽

Positive Effects

BACKGROUND The COVID-19 outbreak has affected the elderly's physical and mental health. The application of information and communication technology, such as mobile health (m-health), can play a significant role in combating this pandemic by changing the behavior and lifestyle of the elderly during this time of crisis. OBJECTIVE This systematic review aimed to synthesize m-health capabilities in providing health services to the elderly during the COVID-19 pandemic, and to identify the factors associated with the success of these tools. METHODS To ﬁnd the relevant studies, a search was conducted in PubMed, Web of Science, Scopus, ProQuest, and Google Scholar. The inclusion criteria were: studies in English that used m-health intervention in all aspects of elderly healthcare during the COVID-19 outbreak, published in peer-reviewed journals from 31 December 2019, and had any research design and methodology. Two authors independently took all the steps of this review, and finally performed narrative synthesis to report the findings. RESULTS Our initial search identified 421 studies, of which 10 met the inclusion criteria. The data analysis showed that all the m-health interventions had positive effects on the health of the elderly. The m-health services for the elderly during the current pandemic were used for therapy, information provision, self-help, monitoring, and mental health consultation purposes. The results also indicated that various factors affected the elderly's use of m-health tools. CONCLUSIONS The application of m-health keeps the elderly and healthcare providers safe, accelerates health service provision, reduces the costs of service delivery, and decreases the risk of morbidity and mortality during the COVID-19 outbreak. The successful use of m-health tools for the elderly in health programs during the current crisis greatly depends on supporting the elderly and overcoming the barriers.

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Protocol for a randomised clinical trial of multimodal postconcussion symptom treatment and recovery: the Concussion Essentials study

BMJ Open ◽

10.1136/bmjopen-2020-041458 ◽

2021 ◽

Vol 11 (2) ◽

pp. e041458

Author(s):

Vicki Anderson ◽

Vanessa C Rausa ◽

Nicholas Anderson ◽

Georgia Parkin ◽

Cathriona Clarke ◽

...

Keyword(s):

Clinical Trial ◽

Randomised Clinical Trial ◽

Normal Activity ◽

Secondary Outcome ◽

Open Label ◽

Human Research Ethics ◽

Postconcussive Symptoms ◽

Study Results ◽

Registration Number ◽

Initial Injury

IntroductionWhile most children recover from a concussion shortly after injury, approximately 30% experience persistent postconcussive symptoms (pPCS) beyond 1-month postinjury. Existing research into the treatment of pPCS have evaluated unimodal approaches, despite evidence suggesting that pPCS likely represent an interaction across various symptom clusters. The primary aim of this study is to evaluate the effectiveness of a multimodal, symptom-tailored intervention to accelerate symptom recovery and increase the proportion of children with resolved symptoms at 3 months postconcussion.Methods and analysisIn this open-label, assessor-blinded, randomised clinical trial, children with concussion aged 8–18 years will be recruited from The Royal Children’s Hospital (The RCH) emergency department, or referred by a clinician, within 17 days of initial injury. Based on parent ratings of their child’s PCS at ~10 days postinjury, symptomatic children (≥2 symptoms at least 1-point above those endorsed preinjury) will undergo a baseline assessment at 3 weeks postinjury and randomised into either Concussion Essentials (CE, n=108), a multimodal, interdisciplinary delivered, symptom-tailored treatment involving physiotherapy, psychology and education, or usual care (UC, n=108) study arms. CE participants will receive 1 hour of intervention each week, for up to 8 weeks or until pPCS resolve. A postprogramme assessment will be conducted at 3 months postinjury for all participants. Effectiveness of the CE intervention will be determined by the proportion of participants for whom pPCS have resolved at the postprogramme assessment (primary outcome) relative to the UC group. Secondary outcome analyses will examine whether children receiving CE are more likely to demonstrate resolution of pPCS, earlier return to normal activity, higher quality of life and a lower rate of utilisation of health services, compared with the UC group.Ethics and disseminationEthics were approved by The RCH Human Research Ethics Committee (HREC: 37100). Parent, and for mature minors, participant consent, will be obtained prior to commencement of the trial. Study results will be disseminated at international conferences and international peer-reviewed journals.Trial registration numberACTRN12617000418370; pre-results.

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The use of biofeedback intervention in the improvement of depression levels: a randomised trial

Acta Neuropsychiatrica ◽

10.1017/neu.2020.46 ◽

2021 ◽

pp. 1-8

Author(s):

Willams Henrique da Costa Maynart ◽

Maria Cicera dos Santos de Albuquerque ◽

Regina Célia Sales Santos ◽

Patrícia de Albuquerque Sarmento ◽

Jadelson Júnior da Silva ◽

...

Keyword(s):

Multinomial Logistic Regression ◽

Randomised Trial ◽

Severe Depression ◽

Randomised Clinical Trial ◽

Control Group ◽

Main Hypothesis ◽

Exact Test ◽

Post Test ◽

Group Sex ◽

Experimental Group

Abstract Objective: To evaluate the use of biofeedback intervention in the levels of depression. The main hypothesis tested if the use of biofeedback improves depression levels compared to the control group. Methods: A randomised clinical trial. The final sample was composed of 36 participants (18 in the experimental group, receiving 6 training, once a week, with biofeedback; and 18 in the control group, who received conventional treatment in the service).Outcome measures were assessed in two stages: pre-test and post-test. The research used the following instruments: demographic survey data, Mini International Neuropsychiatric Interview 5.0.0 and Beck Depression Inventory (BDI). The factors and variables were presented in terms of descriptive and inferential statistics. Fisher’s exact test (p < 0.05) was used to verify the existence of an association between the counting variables. The multinomial logistic regression model was adopted, and the Logit link function was used, as the software RStudio version 3.6.2. Results: The factors that remained in the final model were group, sex, partner, atypical antidepressant, benzodiazepines, mood stabiliser, antiepileptic and antihistamine, according to the levels of depression based on the BDI. The group that did not receive biofeedback intervention had 16 times more chances of increasing the depression levels compared to participants in the experimental group. Conclusion: The use of biofeedback reduces depression, thus, representing a complementary alternative for the treatment of moderate and severe depression, and dysthymia.

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Promotion of active ageing through interactive artificial agents in a smart environment

SN Applied Sciences ◽

10.1007/s42452-021-04567-8 ◽

2021 ◽

Vol 3 (5) ◽

Author(s):

Paulo Menezes ◽

Rui P. Rocha

Keyword(s):

Physical Activity ◽

Pilot Study ◽

The Elderly ◽

Training System ◽

Regular Physical Activity ◽

List Type ◽

Multi Agent System ◽

Agent System ◽

Multi Agent ◽

Elderly Users

Abstract Societies in the most developed countries have witnessed a significant ageing of the population in recent decades, which increases the demand for healthcare services and caregivers. The development of technologies to help the elderly, so that they can remain active and independent for a longer time, helps to mitigate the sustainability problem posed in care services. This article follows this new trend, proposing a multi-agent system composed of a smart camera network, centralised planning agent, a virtual coach, and robotic exercise buddy, designed to promote regular physical activity habits among the elderly. The proposed system not only persuades the users to perform exercise routines, but also guides and accompanies them during exercises in order to provide effective training and engagement to the user. The different agents are combined in the system to exploit their complementary features in the quest for an effective and engaging training system. Three variants of the system, involving either a partial set of those agents or the full proposed system, were evaluated and compared through a pilot study conducted with 12 elderly users. The results demonstrate that all variants are able to guide the user in an exercise routine, but the most complete system that includes a robotic exercise buddy was the best scored by the participants. Article Highlights Proposal of a multi-agent system to help elderly adopting regular physical activity habits. A virtual coach and a robotic exercise buddy provide both guidance and companionship during the exercise. A pilot study conducted with 12 elderly users demonstrated an effective and engaging training system.

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Efficacy and safety of anti-epidermal growth factor receptor agents for the treatment of oesophageal cancer: a systematic review and meta-analysis

BMJ Open ◽

10.1136/bmjopen-2020-046352 ◽

2021 ◽

Vol 11 (3) ◽

pp. e046352

Author(s):

Lijuan Zhang ◽

Yanli Song ◽

Nan Jiang ◽

Yaqi Huang ◽

Bo Dong ◽

...

Keyword(s):

Systematic Review ◽

Growth Factor ◽

Outcome Measures ◽

Oesophageal Cancer ◽

Meta Analysis ◽

Growth Factor Receptor ◽

Cochrane Library ◽

Secondary Outcome ◽

Efficacy And Safety ◽

Positive Effects

ObjectivesDespite remarkable advances in the treatment of oesophageal cancer (OC), the role of antiepidermal growth factor receptor (anti-EGFR) agents in treating OC remains controversial. Herein, a systematic review and meta-analysis were conducted to elucidate the efficacy and safety of anti-EGFR agents in patients with OC.DesignMeta-analysis of randomised controlled trials (RCTs) identified by searching the PubMed, Embase, Web of Science, ClinicalTrials.gov, Cochrane Library, Chinese Biology Medicine, China National Knowledge Infrastructure and Wanfang Data Knowledge Service Platform databases from inception to December 2019. We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.SettingRCTs from any country and healthcare setting.ParticipantsPatients with OC.InterventionsCombination therapy with anti-EGFR agents and conventional treatments versus conventional treatments alone in patients with OC.Primary and secondary outcome measuresOverall survival (OS) and progression-free survival (PFS) were primary outcome measures, and objective response rate (ORR), disease control rate (DCR) and treatment toxicities were secondary outcome measures.ResultsIn total, 25 RCTs comprising 3406 patients with OC were included. Overall, anti-EGFR treatment significantly improved the OS (HR: 0.81, 95% CI 0.74 to 0.89, p<0.00001), ORR (relative risk (RR): 1.33, 95% CI 1.16 to 1.52, p<0.0001) and DCR (RR: 1.22, 95% CI 1.11 to 1.34, p<0.0001) but not PFS (HR: 0.91, 95% CI 0.76 to 1.08, p=0.26). Anti-EGFR treatment was significantly associated with higher incidences of myelosuppression, diarrhoea, acne-like rash and hypomagnesaemia.ConclusionsOverall, anti-EGFR agents have positive effects on OS, the ORR and DCR in OC. However, considering the high incidence of adverse effects, such as myelosuppression, diarrhoea, acne-like rashes and hypomagnesaemia, careful monitoring of patients with OC is recommended during anti-EGFR treatment.Trial registration numberCRD42020169230.

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Benzodiazepine-Induced and Anticholinergic-Induced Delirium in the Elderly

International Psychogeriatrics ◽

10.1017/s1041610291000832 ◽

1991 ◽

Vol 3 (2) ◽

pp. 397-408 ◽

Cited By ~ 56

Author(s):

Larry E. Tune ◽

Fred W. Bylsma

Keyword(s):

Nursing Home ◽

Cognitive Impairments ◽

Anticholinergic Drug ◽

Nursing Home Residents ◽

The Elderly ◽

Quantitative Eeg ◽

Extensive Literature ◽

Drug Levels ◽

Patient Morbidity ◽

Increasing Risk

Encompassing the range from subtle cognitive impairments to frank delirium, toxicity due to benzodiazepines and to anticholinergic-containing compounds is reviewed. For benzodiazepines, an extensive literature suggests that they impair immediate and delayed memory, psychomotor performance, and subjective complaints of station. This, in several studies, results in increased patient morbidity (e.g., increasing risk of hip fractures). Anticholinergic compounds are widely utilized in managing elderly patients, particularly nursing home residents. Toxicity from anticholinergic compounds, detected by anticholinergic drug levels, is significantly correlated with the presence and severity of delirium in a number of settings including postoperative patients and elderly nursing home residents. Possible means of identifying the syndrome by prediction of dose and type of medication, as well as by quantitative EEG, are reviewed.

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