Effect of home-based and remotely supervised combined exercise and cognitive intervention on older adults with mild cognitive impairment (COGITO): study protocol for a randomised controlled trial.

INTRODUCTION: Mild cognitive impairment (MCI) is an intermediate phase between normal cognitive ageing and dementia and poses a serious threat to public health worldwide; however, it might be reversible, representing the best opportunity for secondary prevention against serious cognitive impairment. As a non-pharmacological intervention for those patients, interventions that combine physical exercise and cognitive training, whether delivered simultaneously or sequentially, may have superior effects on various cognitive domains, including global cognition, memory, executive function and attention. The supportive evidence remains incomplete. This study aims to assess the effectiveness of a combined exercise and cognitive intervention in Chinese older adults with mild cognitive impairment (COGITO), empowered by digital therapy and guided by the Health Action Process Model and the Theory of Planned Behaviour (HAPA-TPB theory) in a home-based setting. METHODS AND ANALYSIS: This study is a randomised controlled, assessor-blinded multi-centre study. Four parallel groups will include a total of 160 patients, receiving either a combined exercise and cognitive intervention, an isolated exercise intervention, an isolated cognitive intervention or only health education. These interventions will be conducted at least twice a week for 50 min each session, over 3 months. All interventions will be delivered at home and remotely monitored through RehabApp and Mini-programme, along with an arm-worn heart rate telemetry device. Specifically, supervisors will receive participants' real-time training diaries, heart rates or other online monitoring data and then provide weekly telephone calls and monthly home visits to encourage participants to complete their tasks and address any difficulties based on their training information. Eligible participants are community-dwelling patients with no regular exercise habit and diagnosed with MCI. The primary outcome is cognitive function assessed by the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) and Community Screening Instrument for Dementia (CSI-D), with baseline and three follow-up assessments. Secondary outcomes include quality of life, physical fitness, sleep quality, intrinsic capacity, frailty, social support, adherence, cost-effectiveness and cost-benefit. ETHICS AND DISSEMINATION: The study was approved by the Institutional Review Board of Peking University. Research findings will be presented to stakeholders and published in peer-reviewed journals and at provincial, national and international conferences. TRIAL REGISTRATION NUMBER: ChiCTR2300073900.

Sensory impairment, loneliness, and the discordance between subjective and objective cognitive function among older adults: A multi-cohort study.

OBJECTIVES: This study aimed to examine the association between sensory impairment and the discordance between subjective/objective cognitive function among older adults and test the mediating effect of loneliness. METHODS: We used data from four cohort studies conducted in 16 countries (N = 19,119). Sensory impairment and subjective cognitive impairment were self-reported. Objective cognitive impairment was measured in three dimensions. Generalized estimating equations were conducted to examine the association between sensory impairment and discordance in subjective/objective cognitive function. Cross-lagged panel model and a bootstrap method with 2,000 samples were employed to verify the mediating effect. RESULTS: Sensory impairment was related to an increased risk of subjective cognitive impairment (OR = 4.70, 95 % CI 4.33-5.10), objective impairment (OR = 1.51, 95 %CI 1.31-1.74), as well as the discordance in subjective/objective cognitive function (OR = 1.35, 95 %CI 1.06-1.71 for older adults with normal subjective cognitive function). In contrast, sensory impairment was associated with a decreased risk of discordant subjective/objective cognitive function among those with subjective cognitive impairment (OR = 0.79, 95 %CI 0.66-0.94). Moreover, loneliness mediated the association between sensory impairment and subjective cognitive impairment (standardized indirect effect = 0.002, 95 %CI 0.001-0.004), objective cognitive impairment (standardized indirect effect = 0.005, 95 %CI 0.003-0.007) as well as the discordance in subjective/objective cognitive function (standardized indirect effect = 0.001, 95 %CI 0.001-0.003 for older adults with normal subjective cognitive function). CONCLUSIONS: Significant association between sensory impairment and discordance in subjective/objective cognitive function and the mediating role of loneliness were revealed, varying by subjective cognitive function. Early screening on sensory impairment and targeted interventions on loneliness should be considered in future policies on cognitive impairment.

Pharmacokinetics and safety of a new generic lurasidone: a phase I bioequivalence study in healthy Chinese subjects.

Latuda® is a novel antipsychotic drug for schizophrenia and bipolar depression. A bioequivalence trial was performed to investigate the bioequivalence of Latuda® and its generic drug lurasidone. Two independent trials were carried out, each involving 28 subjects. In the fasting trial, subjects were randomly assigned to two groups (1:1 ratio), receiving either 40 mg of generic lurasidone or Latuda®. After a 7-day washout period, subjects entered the second period with a crossover administration of 40 mg of generic lurasidone or Latuda®. The postprandial study design was similar to that of the fasting study. In the fasting study, the pharmacokinetic (PK) parameter values of generic lurasidone and Latuda® were as follows: the Cmax was 28.84 ± 19.34 ng/ml and 28.22 ± 21.19 ng/ml, respectively; the AUC0-t was 121.39 ± 58.47 h*ng/ml and 118.35 ± 52.24 h*ng/ml, respectively; and the AUC0-∞ was 129.63 ± 63.26 h*ng/ml and 126.59 ± 57.99 h*ng/ml, respectively. The primary pharmacokinetic parameter, Cmax, was assessed for equivalence using reference-scaled average bioequivalence (RSABE), while other parameters (AUC0-t, AUC0-∞) were evaluated using average bioequivalence (ABE). The results indicate that both Cmax and AUC meet the equivalence criteria. In the postprandial study, the PK values of generic lurasidone and Latuda® were as follows: the Cmax was 74.89 ± 32.06 ng/ml and 83.51 ± 33.52 ng/ml, respectively; the AUC0-t was 274.77 ± 103.05 h*ng/ml and 289.26 ± 95.25 h*ng/ml, respectively; and the AUC0-∞ was 302.44 ± 121.60 h*ng/ml and 316.32 ± 109.04 h*ng/ml, respectively. The primary pharmacokinetic parameters (Cmax, AUC0-t, AUC0-∞) were assessed for equivalence using ABE, and both met the equivalence criteria. In the study, lurasidone and Latuda® both exhibited acceptable safety and tolerability. The results displayed that lurasidone and Latuda® were bioequivalent and safe in healthy Chinese participants. Clinical Trial Registry: This trial is registered at chinadrugtrials.org.cn (no.: CTR20191717, date: 2019.08.29).

Association between social integration and loneliness among the female migrant older adults with children: the mediating effect of social support.

BACKGROUND: The number of migrant older adults with children (MOAC) in China has been increasing in recent years, and most of them are women. This study aimed to explore the mediating effect of social support between social integration and loneliness among the female MOAC in Jinan, China. METHODS: In this study, 418 female MOAC were selected using multi-stage cluster random sampling in Jinan, Shandong Province, China. Loneliness was measured by the eight-item version of the University of California Los Angeles Loneliness Scale (ULS-8), and social support was measured by The Social Support Rating Scale (SSRS). Descriptive analyses, t-tests, ANOVA, and structural equation modeling (SEM) were used to illustrate the relationship between social integration, social support, and loneliness. RESULTS: The average scores of ULS-8 and SSRS were 12.9 ± 4.0 and 39.4 ± 5.9 among female MOAC in this study. Social integration and social support were found to be negatively related to loneliness, and the standardized direct effect was -0.20 [95% CI: -0.343 to -0.068] and -0.39 [95% CI: -0.230 to -0.033], respectively. Social support mediated the relationship between social integration and loneliness, and the indirect effect was -0.16 [95% CI: -0.252 to -0.100]. CONCLUSION: The female MOAC's loneliness was at a relatively lower level in this study. It was found that social integration was negatively associated with loneliness, and social support mediated the relationship between them. Helping female MOAC integrate into the inflow city and improving their social support could be beneficial for alleviating their loneliness.

Shor-term effect of coronary artery bypass grafting by different ways for harvesting great saphenous vein / 中国胸心血管外科临床杂志

@#Objective    To compare the short-term effect of no-touch technique and routine method for harvesting great saphenous vein in coronary artery bypass grafting. Methods    The clinical data of patients receiving the great saphenous vein by no-touch technique (a NT group) or routine method (a routine group) for coronary artery bypass grafting from April 2016 to July 2017 in our hospital were retrospectively analyzed. There were 26 males and 13 females with an average age of 60.1±8.0 years ranging from 40 to 75 years in the routine group, as well as 21 males and 17 females with an average age of 61.3±6.9 years ranging from 38 to 75 years in the NT group. The operation time, postoperative ventilation duration, postoperative myocardial injury index, postoperative complications, postoperative ejection fraction, postoperative hospital stays and other indicators were compared. Results    There was no statistical difference between the two groups in operation time, postoperative ventilation time, postoperative ejection fraction or postoperative hospital stays. Incisions of postoperative lower extremity in two groups successfully healed. There was no recurrence of acute myocardial infarction or death. All patients recovered and discharged. One patient was treated with thoracotomy in the routine group. One patient in the NT group had bad healing of chest incision, and one patient with acute kidney injury recovered after treatment. Conclusion    The great saphenous vein by no touch technique has a good early effect in coronary artery bypass grafting without increasing the risk of surgery.