A phase II, single-center, randomized, double-blind, parallel control clinical study evaluating the immunogenicity and safety of a two-dose schedule of serogroups ACYW meningococcal polysaccharide conjugate vaccine.

BACKGROUND: This was a single-center, randomized, double-blind, parallel control study evaluating the immunogenicity and safety of a two-dose schedule of serogroups ACYW meningococcal polysaccharide conjugate vaccine with tetanus toxoid (TT) conjugate protein, in infants and toddlers of 3-35 months old. METHOD: 720 participants were stratified according to the age of 3-5 months old, 6-11 months old, and 12-35 months old and randomly assigned with an equal ratio to two different dose groups, i.e., 40- and 20-µg doses. Blood samples were taken from all participants before the first vaccination and 30 days after the full-course vaccination to detect the serogroups ACYW meningococcal antibodies. All adverse events occurred within 30 days after vaccination of each dose, and serious adverse events occurred within six months after full-course vaccination were collected for safety evaluation. This study was registered at the China drug trial registration with the identifier CTR 20182031. RESULTS: After 30 days of full-course vaccination, 92.78 % (95 % CI: 85.70 %-100.00 %) showed the immune response against all serogroups in both high-dose and low-dose groups by rabbit serum bactericidal antibody assay (rSBA) and the geometric mean titer (GMT) of all serogroups showed a high level (74.6-505.8, 95 % CI: 56.4-615.7). However, no significant difference between different dose groups was observed (P > 0.05). The common local and systemic adverse events in both groups were redness (3 %-7%), and fever (26 %-65 %), respectively. In addition, the grade 3 adverse event related to the vaccine was fever (1.67 %-12.50 %). No serious adverse event was reported to be associate with the vaccination. CONCLUSION: The serogroups ACYW meningococcal polysaccharide conjugate vaccine was safe and effective in the population aged 3-35 months. The vaccine efficacy and safety of the 20-µg dose group were not less than that of the 40-µg dose group.

Effects of virtual reality combined cognitive and physical interventions on cognitive function in older adults with mild cognitive impairment: A systematic review and meta-analysis.

OBJECTIVE: Combined cognitive and physical interventions based on virtual reality may help delay the progression of MCI to dementia or prevent dementia. However, their efficacy is less well studied compared to pharmaceutical treatments. The purpose of this review was to evaluate the effects of cognitive and physical interventions based on virtual reality on cognitive function (global cognition, memory or executive function/attention) of older adults with mild cognitive impairment. METHODS: We searched the PubMed, Web of Science, Scopus, Embase, Cochrane Library, PsycINFO, CINAHL and IEEE from inception to 13 May 2021. Only randomized controlled trials which incorporated virtual reality cognitive and physical components targeted to individuals with mild cognitive impairment were eligible. Two researchers independently conducted document retrieval, study selection, data extraction, and methodological quality evaluation. RESULT: 7 randomized controlled trials were included in a total of 8 articles. No studies were rated as having a "high" risk of overall bias. The results of a meta-analysis showed that VR combined cognitive and physical interventions enhanced the global cognitive (MD = 2.66, 95% CI = 1.79-3.54, P = 0.03, I 2 = 68%) abilities of older adults with mild cognitive impairment. The meta-analysis indicated that after virtual reality combined cognitive and physical interventions, effects on memory (SMD = -0.03, 95% CI = -0.60 to 0.55, P = 0.78, I 2 = 0%) and executive function/attention (SMD = -0.19, 95% CI = -0.74 to 0.36, P = 0.09, I 2 = 53%) were not statistically significant. CONCLUSIONS: The present meta-analysis verifies the potential rehabilitative effects of virtual reality combined cognitive and physical interventions for older adults with mild cognitive impairment. More research is also needed to determine the optimal intensity and timing of interventions in the future.

Effectiveness of clown intervention for pain relief in children: A systematic review and meta-analysis.

BACKGROUND: Pain is common in children receiving medical procedures, and there is a lack of adequate awareness and management. In addition, children who undergo medical procedures involving pain may also experience stress, crying and prolonged hospitalisation. Clown intervention is a promising nonpharmacological intervention. However, studies on the effectiveness of clown intervention in pain management have reported conflicting findings. OBJECTIVE: To evaluate the effectiveness of clown intervention in relieving pain in children, as well as its effects on cortisol levels, crying duration and length of hospital stay. DESIGN: Systematic review and meta-analysis of randomised controlled studies. DATA SOURCES: PubMed, Web of Science (SCI), Embase, PsycINFO, the Cochrane Library, Chinese National Knowledge Infrastructure (CNKI), Weipu (VIP), Wanfang Data and SinoMed were systematically searched from inception date to December 31, 2020. REVIEW METHODS: Two reviewers independently used the Cochrane risk of bias tool to assess the risk of bias of the included studies. Meta-analysis was conducted when data were available, otherwise, a narrative description was provided. Data were analysed using Review Manager 5.3. The review process is reported according to PRISMA. RESULTS: Nine studies including 852 children met the inclusion criteria. The results showed that compared with standard care, clown intervention was beneficial for relieving pain. Further subgroup analysis showed that it was more effective with children aged 2-7 years. The duration of crying after the procedure and the length of stay were shortened, but there was no significant difference in cortisol levels. CONCLUSION: Clown intervention may be a promising way to relieve acute pain in children, especially those aged 2-7 years. It also seems to shorten the duration of crying and the length of hospital stays, but the effect on cortisol levels is still uncertain. More high-quality randomised controlled trials are needed to confirm these results and take into account different age groups, cultural backgrounds and specific populations.

The effect of combined cognitive intervention and physical exercise on cognitive function in older adults with mild cognitive impairment: a meta-analysis of randomized controlled trials.

BACKGROUND: The state of mild cognitive impairment (MCI) provides an optimal window for preventing progression to dementia. Combined cognitive intervention and physical exercise may yield additive and synergistic effects on cognition in older adults with MCI. OBJECTIVES: The purpose of this study was to assess the efficacy of a combined intervention to improve cognition in older adults with MCI by comparing a control group that underwent only cognitive intervention, a control group that underwent only physical exercise, and a control group that did not undergo cognitive intervention or physical exercise. DESIGN: Meta-analysis of randomized controlled trials (RCTs). DATA SOURCES: The online databases of PubMed, Web of Science, Embase, the Cochrane Library, PsycINFO, and CINAHL were systematically searched. REVIEW METHODS: The outcomes were global cognition, memory, and executive function/attention. A sensitivity analysis was conducted when the I2 statistic was > 50%. RESULTS: A total of 16 studies were included. The results showed that the combined intervention had positive effects on global cognition compared to the effects of the other control group [SMD = 0.27, 95% CI (0.09, 0.44), p = 0.003]. Regarding memory, the combined intervention had positive effects compared to the effects observed in the single physical exercise group [SMD = 0.25, 95% CI (0.07, 0.44), p = 0.006] and the other control group [SMD = 0.29, 95% CI (0.12, 0.47), p = 0.001]. For executive function/attention, the combined intervention had also positive effects compared to the effects of the single cognitive intervention group [SMD = 0.28, 95% CI (0.09, 0.47), p = 0.004], the single physical exercise group [SMD = 0.32, 95% CI (0.16, 0.49), p = 0.0002], and the other control group [SMD = 0.23, 95% CI (0.05, 0.41), p = 0.01]. CONCLUSIONS: The combined intervention resulted in cognitive benefits in older adults with MCI and exhibited limited superiority over the single cognitive intervention and the single physical exercise on cognitive subdomains.

A Virtual Supermarket Program for the Screening of Mild Cognitive Impairment in Older Adults: Diagnostic Accuracy Study.

BACKGROUND: Mild cognitive impairment (MCI) is often a precursor of dementia, and patients with MCI develop dementia at a higher rate than healthy older adults. Early detection of cognitive decline at the MCI stage supports better planning of care and interventions. At present, the use of virtual reality (VR) in screening for MCI in older adults is promising, but there is little evidence regarding the use of virtual supermarkets to screen for MCI. OBJECTIVE: The objectives of this study are to validate a VR game-based test, namely, the Virtual Supermarket Program (VSP), for differentiating patients with MCI and healthy controls and to identify cutoff scores for different age levels. METHODS: Subjects were recruited from several nursing homes and communities in Changchun, China. They were divided into a healthy control group (n=64) and an MCI group (n=62). All subjects were administered the VSP and a series of neuropsychological examinations. The study determined the optimal cutoff, discriminating validity, concurrent validity, and retest reliability of the VSP. We used the area under the receiver operating characteristic curve (AUC) to evaluate the discriminating validity and obtain the optimal cutoff values. Pearson correlation analysis and the intraclass correlation coefficient were used to evaluate the concurrent validity and retest reliability, respectively. RESULTS: A cutoff score of 46.4 was optimal for the entire sample, yielding a sensitivity of 85.9% and specificity of 79.0% for differentiating individuals with MCI and healthy controls, and the AUC was 0.870 (95% CI 0.799-0.924). The median index of VSP score was 51.1 (range 42.6-60.0). There was a moderate positive correlation between the VSP total score and Mini-Mental State Examination score (r=0.429, P<.001). There was a strong positive correlation between VSP total score and Montreal Cognitive Assessment score (r=0.645, P<.001). The retest reliability of the VSP was feasible (r=0.588, P=.048). CONCLUSIONS: The VSP is interesting and feasible for subjects. It shows high sensitivity and specificity for the identification of MCI in older adults, which makes it a promising screening method. The VSP may be generalized to older adults in other countries, although some cultural adaptation may be necessary. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2000040074; https://www.chictr.org.cn/showprojen.aspx?proj=64639.

How Exercise Protects Against Mild Cognitive Impairment in Nursing Home-Dwelling Older Adults: A Path Analysis.

ABSTRACT: To explore how exercise protects against mild cognitive impairment (MCI) from physical, psychological, and social perspectives, we conducted a cross-sectional study in four nursing homes in Changchun, China, selected by convenience sampling. A total of 338 older adults aged 60 years or more with normal cognition or MCI were included. Data including demographic characteristics, exercise habits, frailty status, depression, sleep quality, social support, and cognitive status were collected. Weighted least squares estimation with mean and variance adjusted chi-square and bootstrapping with 2000 resamples were used to conduct the analyses through Mplus 8.3. The results showed that both direct and indirect effects of exercise on MCI were significant. Frailty and depression were two independent mediating factors, and depression could also play a mediating role when combined with sleep quality or frailty. Social support played a partial mediating role between exercise and depression. Formulations of exercise programs for MCI prevention and improvement in nursing home-dwelling older adults should consider the mediating factors.

Effects of music intervention on sleep quality of older adults: A systematic review and meta-analysis.

BACKGROUND: Music interventions have several benefits for sleep quality. However, the effects of music interventions on sleep quality in older adults are controversial. OBJECTIVE: To summarize and evaluate the efficacy of music interventions on sleep quality in older adults. METHODS: The Cochrane Library, Embase, PubMed, Web of Science and Chinese National Knowledge Infrastructure (CNKI) were systematically retrieved until June 2020, updated on March 13, 2021. Both experimental and quasi-experimental studies were included if they evaluated the efficacy of music interventions on sleep outcomes in older adults. The methodological quality was assessed by the Cochrane RoB 2.0 and ROBINS-I Tool. The random effects models and effect measure (MD) were adopted, and sensitivity analysis by omitting each study was conducted to explore the source of heterogeneity. RESULTS: A total of 489 participants from 9 studies met the inclusion criteria. 6 studies were included in meta-analysis and sensitivity analysis, and 3 studies were included in the qualitative analysis. Main concerns about risk of bias were lack of blinding participants and investigators, and confounding factors might exist in non-RCTs. The Post-hoc meta-analysis indicated that music interventions might have a positive effect on sleep quality [MD = -2.64, 95 % CI (-3.76, -1.53), p <  0.001; I2 = 75.0 %]. Only one study evaluated adverse events and reported zero discomfort. CONCLUSIONS: The results indicated that music interventions might be beneficial for improving sleep quality, especially in sleep latency, sleep duration, sleep efficiency and sleep of daytime dysfunction in elderly individuals.

Experiences of nursing home-dwelling older adults with mild cognitive impairment participating in a Chinese square dancing program: A qualitative study.

To explore the experiences of older adults with mild cognitive impairment participating in a Chinese square dancing program, we conducted a qualitative study through individual semistructured interviews between September 2019 and November 2019 in the nursing home where the program was implemented. Purposive sampling was used to select participants from those completing the dancing program. The sample size was determined by data saturation. Thirteen participants were included. The data were analyzed using content analysis. Three main categories, including benefits associated with exercise, facilitators of adherence, and barriers to adherence, emerged. In conclusion, participants reported multiple positive experiences; thus, square dancing may be an acceptable and desirable intervention for older adults with mild cognitive impairment. In future promotion processes, attention should be paid to the progressive nature of the activity, the use of professionally trained instructors, participants' awareness of the benefits gained, and the forgetfulness of participants.

Detection of Mild Cognitive Impairment Based on Virtual Reality: A Scoping Review.

BACKGROUND: To delay the decline in cognition and reduce the incidence of dementia, the precise detection of Mild Cognitive Impairment (MCI) is necessary. The application of Virtual Reality (VR) technology in this detection can overcome the shortage of traditional paper-and-pencil tests. OBJECTIVE: This review aimed to summarize the research progress of the detection of MCI using VR. METHODS: Eight databases from their inception to November 19, 2019, were systematically searched for studies applying VR in the detection of MCI. A thematic analysis was conducted according to the specific detection purpose and the main corresponding cognitive domains assessed were summarized; characteristics of the VR applications were also summarized. RESULTS: Twenty-eight studies were finally included. The detection purposes included discrimination between healthy controls and those with MCI, discrimination between aMCI subtypes, detection of MCI patients at risk of Alzheimer's Disease (AD), and discrimination between MCI and AD. VR tasks assessing spatial memory were applicable for all detection purposes, and the assessment of combinations of memory and executive function seemed more sensitive. Executive function and intentional episodic memory could be assessed to discriminate among healthy controls, individuals with MCI and those with AD. Incidental episodic memory was effective in detecting MCI with hippocampal atrophy. The most common characteristics of the VR applications were the use of semi-immersion, joysticks or gamepad interactions and simple, one-time behavioral assessments. CONCLUSION: VR applications are promising in the detection of MCI, but further research is needed for clinical use.

Effects of Chinese square dancing on older adults with mild cognitive impairment.

The present study aimed to explore the effects of square dancing on global cognition, depressive symptoms, balance, and quality of life of older adults with mild cognitive impairment. We studied 66 older adults with mild cognitive impairment in a large nursing home. Participants were assigned to the intervention group (n = 33) or the control group (n = 33), according to their residential floor, which was determined by coin tossing. The intervention group underwent a 12-week Chinese square dancing routine, while the control group maintained usual lifestyle (without square dancing). Outcomes were assessed at baseline and at weeks 6 and 12. The results showed positive effects of square dancing on all outcomes assessed, especially on depressive symptoms and quality of life-related mental well-being of the participants. This study showed that square dancing is a promising strategy for older adults with mild cognitive impairment and that long-term adherence can be beneficial.