BackgroundThe primary objective of this trial is to investigate the effects of a short-term exercise program on neuropsychiatric signs and symptoms in acute hospital dementia care.MethodsWithin a hospital-based randomized controlled trial, the intervention group conducted a 2-week exercise program with four 20-min exercise sessions on 3 days per week. The control group conducted a social stimulation program. Effects on neuropsychiatric signs and symptoms were measured via the Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change, the Neuropsychiatric Inventory, and the Cohen-Mansfield Agitation Inventory. The antipsychotic and sedative dosage was quantified by olanzapine and diazepam equivalents.ResultsEighty-five patients were randomized via minimization to an intervention group (IG) and a control group (CG). Seventy patients (82%) (mean age 80 years, 33 females, mean Mini Mental State Examination score 18.3 points) completed the trial. As compared to the CG (n = 35), the IG (n = 35) showed significantly reduced neuropsychiatric signs and symptoms. Especially, agitated behavior and lability improved. There were no between-group differences concerning antipsychotic and benzodiazepine medication.ConclusionsThis exercise program is easily applicable in hospital dementia care and significantly reduces neuropsychiatric signs and symptoms in patients suffering from predominantly moderate stages of dementia.Trial registrationGerman Clinical Trial Register DRKS00006740. Registered 28 October 2014.
A new probe drug cocktail containing substrates of important drug transporters was tested for mutual interactions in a clinical trial. The cocktail consisted of (predominant transporter; primary phenotyping metric): 10 mg adefovirdipivoxil (OAT1; renal clearance (CL R )), 100 mg sitagliptin (OAT3; CL R ), 500 mg metformin (several renal transporters; CL R ), 2 mg pitavastatin (OATP1B1; clearance/F), and 0.5 mg digoxin (intestinal P-gp, renal P-gp, and OATP4C1; peak plasma concentration (C max ) and CL R ). Using a randomized six-period, open change-over design, single oral doses were administrated either concomitantly or separately to 24 healthy male and female volunteers. Phenotyping metrics were evaluated by noncompartmental analysis and compared between periods by the standard average bioequivalence approach (boundaries for ratios 0.80-1.25). Primary metrics supported the absence of relevant interactions, whereas secondary metrics suggested that mainly adefovir was a victim of minor drug-drug interactions (DDIs). All drugs were well tolerated. This cocktail may be another useful tool to assess transporter-based DDIs in vivo.
Introduction To objectively quantify patients' physical activity and analyze the relationships between physical activity levels, psychopathology, and sedative medication in acute hospital dementia care. Materials and Methods In this cross‐sectional study, we assessed the patients' physical activity based on data collection by hybrid motion sensors attached on their lower back. Daily doses of antipsychotics have been converted to olanzapine‐equivalents and daily benzodiazepine medication is reported as diazepam‐equivalents. We assessed patients' neuropsychiatric symptoms with the Neuropsychiatric Inventory and the Cohen‐Mansfield Agitation Inventory. Results We analyzed motion sensor data from 64 patients (MMSE M = 18.6). On average, patients were lying for 11.5 hours, sitting/standing sedentary for 10.3 hours, sitting/standing active for 1.0 hours, and walking for 1.2 hours per day. The analysis revealed no correlations between patients' physical activity and antipsychotic or benzodiazepine medication. More severe neuropsychiatric symptoms were associated with a decrease in the patients' physical activity (r = .32, P = .01). In particular, patients with apathy symptoms were less physically active than patients without apathy symptoms. Discussion The results reveal that most of the patients in acute dementia care had very low levels of physical activity. Their physical inactivity may be due to the severity of their neuropsychiatric symptoms, especially apathy. Antipsychotic and benzodiazepine medication appeared to have less impact on patients' physical activity. Dementia care should pay more attention to prevent physical inactivity in patients.
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