Meaningful Endpoints for Idiopathic Pulmonary Fibrosis (IPF) Clinical Trials: Emphasis on 'Feels, Functions, Survives'. Report of a Collaborative Discussion in a Symposium with Direct Engagement from Representatives of Patients, Investigators, the National Institutes of Health, a Patient Advocacy Organization, and a Regulatory Agency.

Background: Idiopathic pulmonary fibrosis (IPF) carries significant mortality and unpredictable progression, with limited therapeutic options. Designing trials with patient-meaningful endpoints, enhancing the reliability and interpretability of results, and streamlining the regulatory approval process are of critical importance to advancing clinical care in IPF. Methods: A landmark in-person symposium in June 2023 assembled 43 participants from the US and internationally, including patients with IPF, investigators, and regulatory representatives, to discuss the immediate future of IPF clinical trial endpoints. Patient advocates were central to discussions, which evaluated endpoints according to regulatory standards and the FDA's 'feels, functions, survives' criteria. Results: Three themes emerged: 1) consensus on endpoints mirroring the lived experiences of patients with IPF; 2) consideration of replacing forced vital capacity (FVC) as the primary endpoint, potentially by composite endpoints that include 'feels, functions, survives' measures or FVC as components; 3) support for simplified, user-friendly patient-reported outcomes (PROs) as either components of primary composite endpoints or key secondary endpoints, supplemented by functional tests as secondary endpoints and novel biomarkers as supportive measures (FDA Guidance for Industry (Multiple Endpoints in Clinical Trials) available at: https://www.fda.gov/media/162416/download). Conclusions: This report, detailing the proceedings of this pivotal symposium, suggests a potential turning point in designing future IPF clinical trials more attuned to outcomes meaningful to patients, and documents the collective agreement across multidisciplinary stakeholders on the importance of anchoring IPF trial endpoints on real patient experiences-namely, how they feel, function, and survive. There is considerable optimism that clinical care in IPF will progress through trials focused on patient-centric insights, ultimately guiding transformative treatment strategies to enhance patients' quality of life and survival.

Deep Learning-Based ADHD and ADHD-RISK Classification Technology through the Recognition of Children's Abnormal Behaviors during the Robot-Led ADHD Screening Game.

Although attention deficit hyperactivity disorder (ADHD) in children is rising worldwide, fewer studies have focused on screening than on the treatment of ADHD. Most previous similar ADHD classification studies classified only ADHD and normal classes. However, medical professionals believe that better distinguishing the ADHD-RISK class will assist them socially and medically. We created a projection-based game in which we can see stimuli and responses to better understand children's abnormal behavior. The developed screening game is divided into 11 stages. Children play five games. Each game is divided into waiting and game stages; thus, 10 stages are created, and the additional waiting stage includes an explanation stage where the robot waits while explaining the first game. Herein, we classified normal, ADHD-RISK, and ADHD using skeleton data obtained through games for ADHD screening of children and a bidirectional long short-term memory-based deep learning model. We verified the importance of each stage by passing the feature for each stage through the channel attention layer. Consequently, the final classification accuracy of the three classes was 98.15% using bi-directional LSTM with channel attention model. Additionally, the attention scores obtained through the channel attention layer indicated that the data in the latter part of the game are heavily involved in learning the ADHD-RISK case. These results imply that for ADHD-RISK, the game is repeated, and children's attention decreases as they progress to the second half.

Cognitive Outcomes of Children with Very Low Birth Weight at 3 to 5 Years of Age.

BACKGROUND: The cognitive consequences and risk factors based long-term outcome of very-low-birth-weight (VLBW; < 1,500 g) infants in Korea has not been studied. The aim of this study was to determine the influence of perinatal and neonatal risk factors on the cognitive performance of VLBW children at 3 to 5 years of age. METHODS: We enrolled 88 VLBW infants without cystic periventricular leukomalacia for the assessment of their demographic data, cognitive performance, and development of cerebral palsy (CP) at 3 to 5 years of age. Cognitive performance was assessed using the Korean version of the Wechsler Preschool and Primary Scale of Intelligence IV. Growth data were assessed with measurements of weight, height, and head circumference (HC) at the corrected ages of 6, 12, and 18 months, and 3 to 5 years of age. RESULTS: In the VLBW group, the full-scale intelligence quotient (FSIQ) was 96.1 ± 15.2 at the mean age of 4.5 years. The incidence rate of CP was 3.4%. Overall, 17% (15/88) of the VLBW children had a below-average FSIQ (< 85). We divided the VLBW children into the abnormal FSIQ group (< 85, n = 15) and the normal FSIQ group (≥ 85, n = 73). VLBW children with intrauterine growth retardation (IUGR) was associated with a below-average FSIQ at the mean age of 4.5 years (< 85, 8/15, 53.3% vs. ≥ 85, 5/73, 6.8%; P < 0.001). After controlling for associated clinical factors, IUGR in the VLBW children was found to be associated with an abnormal FSIQ at the mean age of 4.5 years (P = 0.025). The weight, height, and HC obtained for both groups showed that normal growth was maintained at the mean age of 4.5 years with no significant difference between abnormal and normal FSIQ groups. CONCLUSION: Fifteen of 88 (17%) of the VLBW children had a below-average FSIQ (< 85). VLBW with IUGR is associated with poor cognitive outcomes at the mean age of 4.5 years.

Probing Multi-Target Action of Phlorotannins as New Monoamine Oxidase Inhibitors and Dopaminergic Receptor Modulators with the Potential for Treatment of Neuronal Disorders.

Modulation of multiple protein targets with a single compound is essential for the effective treatment of central nervous system disorders. In our previous G protein-coupled receptor (GPCR) cell-based study, a selective human monoamine oxidase (hMAO)-A inhibitor, eckol, stimulated activity of dopamine D3 and D4 receptors. This result led to our interest in marine phlorotannin-mediated modulation of hMAO enzymes and related GPCRs in neuronal disorders. Here, we evaluate the multi-target effects of phloroglucinol, phlorofucofuroeckol-A (PFF-A), and dieckol by screening their modulatory activity against hMAO-A and -B and various neuronal GPCRs. Among the tested phlorotannins, PFF-A showed the strongest inhibitory activity against both hMAO isoforms, with higher selectivity toward hMAO-B than hMAO-A. Enzyme kinetics and docking data revealed that PFF-A noncompetitively acts on hMAOs into the alternative binding pocket of enzymes with allosteric functions. In a functional assay for GPCR screening, dieckol and PFF-A exhibited a multi-target combination of D3R/D4R agonism and D1/5HT1A/NK1 antagonism. In particular, they effectively stimulated D3R and D4R, compared to other GPCRs. Docking analysis confirmed that dieckol and PFF-A successfully docked into the conserved active sites of D3R and D4R and interacted with aspartyl and serine residues in the orthosteric binding pockets of the respective receptors. Based on our experimental and computational data, we established the structure-activity relationship between tested phlorotannins and target proteins, including hMAOs and GPCRs. Our current findings suggest that hMAO inhibitors dieckol and PFF-A, major phlorotannins of edible brown algae with multi-action on GPCRs, are potential agents for treatment of psychological disorders and Parkinson's disease.

Quantified Activity Measurement for Medical Use in Movement Disorders through IR-UWB Radar Sensor.

Movement disorders, such as Parkinson's disease, dystonia, tic disorder, and attention-deficit/hyperactivity disorder (ADHD) are clinical syndromes with either an excess of movement or a paucity of voluntary and involuntary movements. As the assessment of most movement disorders depends on subjective rating scales and clinical observations, the objective quantification of activity remains a challenging area. The purpose of our study was to verify whether an impulse radio ultra-wideband (IR-UWB) radar sensor technique is useful for an objective measurement of activity. Thus, we proposed an activity measurement algorithm and quantitative activity indicators for clinical assistance, based on IR-UWB radar sensors. The received signals of the sensor are sufficiently sensitive to measure heart rate, and multiple sensors can be used together to track the positions of people. To measure activity using these two features, we divided movement into two categories. For verification, we divided these into several scenarios, depending on the amount of activity, and compared with an actigraphy sensor to confirm the clinical feasibility of the proposed indicators. The experimental environment is similar to the environment of the comprehensive attention test (CAT), but with the inclusion of the IR-UWB radar. The experiment was carried out, according to a predefined scenario. Experiments demonstrate that the proposed indicators can measure movement quantitatively, and can be used as a quantified index to clinically record and compare patient activity. Therefore, this study suggests the possibility of clinical application of radar sensors for standardized diagnosis.

In vitro and in vivo anti-inflammatory activities of ethanolic extract of Sargassum confusum.

This study was to investigate the anti-inflammatory activity of ethanolic extract of Sargassum confusum (SCEE). LPS is recognized by TLR4 on the macrophage surface, which activates the NF-κB and MAPK signaling pathways, increasing the expression of inflammatory cytokine like interleukin-6 (IL-6), IL-1ß, and tumor necrosis factor (TNF)-α and inflammatory mediators such as nitric oxide (NO) and cyclooxygenase-2 (COX-2). The anti-inflammatory effect of SCEE (0, 1, 10, 50 µg/mL) was identified using LPS stimulated RAW 264.7 macrophages. As a result, it was confirmed that inflammatory factors were suppressed by inhibiting expression of COX-2 and iNOS without any cytotoxicity. In addition, phosphorylation of ERK, JNK and NF-κB p65, transcription factors, were inhibited by SCEE does-dependent manner. These results suggest that SCEE has an anti-inflammatory effect and can be used as a material for health functional foods to prevent inflammatory diseases.

Anti-Atopic Activities of Sargassum horneri Hot Water Extracts in 2,4-Dinitrochlorobezene-Induced Mouse Models.

Atopic dermatitis (AD) is a chronic inflammation associated with skin hypersensitivity caused by environmental factors. The objent of this study was to assess the hot water extracts of Sargassum horneri (SHHWE) on AD. AD was induced by spreading 2,4-dinitrochlorobenzene (DNCB) on the BALB/c mice. The efficacy of SHHWE was tested by observing the immunoglobulin E (IgE), cytokine, skin clinical severity score and cytokine secretions in concanavalin A (Con A)-stimulated splenocytes. The levels of interleukine (IL)-4, IL-5 and IgE, the pro-inflammatory cytokines that are closely related, were notably suppressed in a does-dependent manner by SHHWE, whereas the level of interferon γ (IFN-γ), the atopy-related Th1 cytokine inhibiting the production of Th2 cytokines, was increased. Therefore, these results show that SHHWE has a potent anti-inhibitory effect on AD and is highly valuable for cosmetic development.

Properties and anti-inflammatory effects of Sargassum muticum enzymatic extracts decomposed using crude enzyme from Shewanella oneidensis PKA1008.

This study was conducted to investigate the general properties of an enzymatic extract of Sargassum muticum (SM) produced using a crude enzyme from Shewanella oneidensis PKA 1008 and their anti-inflammatory activities. The SM was mixed with crude enzymes from S. oneidensis PKA 1008 (1:1 (v/v)) and incubated at 30 °C for 0, 3, 6, 12, 24, 48, and 60 h. S. oneidensis PKA 1008 crude enzyme showed the highest SM enzymatic extracts degradation ability when reacted with SM for 48 h. These evaluations demonstrated a 134.25% increase in reducing sugar content and a 14.90% reduction in viscosity at 48 h. The pH, lightness (L*) and yellowness (b*) of the SM enzymatic extracts decreased significantly with increasing reaction time. Moreover, the SM enzymatic extracts demonstrated significant anti-inflammatory activity. These results indicate that the crude enzyme from S. oneidensis PKA 1008 can be used to enhance the polysaccharide degradation of SM, and the resultant oligosaccharides may have an anti-inflammatory effect.

Effects of Gamma Irradiation on Inhibition of Urease Activity and Fishy Smell in Mackerel (Scomber japonicus) during Refrigerated Storage.

In this study, gamma-irradiated mackerel (Scomber japonicus) meat was stored in a refrigerator for 20 days to examine the physicochemical changes related to fishy smell. The effect of gamma irradiation on the inhibition of the activity of crude urease extracted from Vibrio parahaemolyticus was also evaluated. Increased levels of trimethylamine (TMA) and volatile basic nitrogen (VBN) content, which are the main components causing fishy smell, were significantly reduced by day 20 of storage after gamma irradiation, indicating that freshness was maintained during storage. The ammonia nitrogen contents of 3, 7, 10, and 20 kGy gamma-irradiated groups were significantly decreased by 6.5, 15.2, 17.4, and 23.9%, respectively, compared to non-irradiated groups on day 20 of storage. In addition, urease activity decreased in a gamma irradiation intensity-dependent manner. Volatile organic compounds (VOCs) were measured during the storage of gamma-irradiated mackerel meat. The contents of ethanol, 2-butanone, 3-methylbutanal, and trans-2-pentenal, which are known to cause off-flavors due to spoilage of fish, were significantly reduced by day 20 of storage. Therefore, gamma irradiation can be considered useful for inhibiting urease activity and reducing fishy smell during fish storage.

A Novel Robot-Assisted Kinematic Measure for Children with Attention-Deficit/Hyperactivity Disorder: A Preliminary Study.

OBJECTIVE: Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder characterized by inattention, hyperactivity, and impulsivity. In contrast to neurocognitive measurements of inattention and impulsivity, there has been limited research regarding the objective measurement of hyperactivity in youths with ADHD. The purpose of the present study was to investigate the clinical effectiveness of a newly developed Robot-assisted Kinematic Measure for ADHD (RAKMA) in children with ADHD. METHODS: In total, 35 children with ADHD aged 5 to 12 years and 50 healthy controls (HCs) were recruited, and the parents completed the Child Behavior Checklist and the Korean ADHD Diagnostic Scale. RAKMA performance was represented by RAKMA stimulus-response and hyperactivity variables. We compared the RAKMA performance of those with ADHD and with that of HCs and also investigated the correlation between the RAKMA variables and ADHD clinical scale scores. RESULTS: Significant differences between the ADHD and HC groups were observed regarding most RAKMA variables, including correct reactions, commission errors, omission errors, reaction times, migration distance, and migration speed scores. Significant correlations were detected between various ADHD clinical scale scores and RAKMA variables. CONCLUSION: The RAKMA was a clinically useful tool for objectively measuring hyperactivity symptoms in children with ADHD. Further studies with larger samples are warranted.

Effect of High Hydrostatic Pressure Treatment on Urease Activity and Inhibition of Fishy Smell in Mackerel (Scomber japonicus) during Storage.

In this study, the physicochemical changes related to fishy smell were determined by storing high hydrostatic pressure (HHP)-treated mackerel (Scomber japonicus) meat in a refrigerator for 20 days. The inhibition of crude urease activity from Vibrio parahaemolyticus using HHP treatment was also investigated. The mackerel meat storage experiment demonstrated that production of trimethylamine (TMA) and volatile basic nitrogen (VBN), the main components of fishy smell, was significantly reduced on the 20th day of storage after the HHP treatment compared to the untreated mackerels. The results demonstrated that the increased ammonia nitrogen rates in the 2000, 3000, and 4000 bar, HHP-treated groups decreased by 23.8%, 23.8%, and 31.0%, respectively, compared to the untreated groups. The enzyme activity of crude urease was significantly reduced in the HHP-treated group compared to that in the untreated group. Measurement of the volatile organic compounds (VOCs) in mackerel meat during storage indicated that the content of ethanol, 2-butanone, 3-methylbutanal, and trans-2-pentenal, which are known to cause off-flavor due to spoilage, were significantly reduced by HHP treatment. Collectively, our results suggested that HHP treatment would be useful for inhibiting the activity of urease, thereby reducing the fishy smells from fish and shellfish.

Novel application of an optical inspection system to determine the freshness of Scomber japonicus (mackerel) stored at a low temperature.

This study evaluated the use of an optical inspection system (OIS) to determine the freshness of mackerel (Scomber japonicus). The correlations between the light reflection intensity (LRI) of mackerel eyes (determined using an OIS) and the volatile basic nitrogen content (VBN) and K-value were analyzed. After unloading at the harbor, the mackerel were stored at 4 °C for 9 days and the VBN, K-value, and LRI were determined at 3-day intervals. During storage, the LRI, VBN, and K-value all increased. Furthermore, the LRI was correlated with the K-value and VBN. Therefore, although the LRI cannot be applied as an absolute standard for evaluating freshness, the LRI using an OIS is a suitable nondestructive method for evaluating freshness for quality and risk management in the processing industry when handling large numbers of fish.

Characterization of Undaria pinnatifida Root Enzymatic Extracts Using Crude Enzyme from Shewanella oneidensis PKA 1008 and Its Anti-Inflammatory Effect.

This study investigated the characterization and functionality of Undaria pinnatifida root (UPT) extracts, degraded using a crude enzyme from Shewanella oneidensis PKA1008. To obtain the optimum degrading conditions, the UPT was mixed with alginate degrading enzymes from S. oneidensis PKA 1008 and was incubated at 30°C for 0, 3, 6, 12, 24, and 48 h. The alginate degrading ability of these enzymes was then evaluated by measuring the reducing sugar, viscosity, pH and chromaticity. Enzymatic extract at 24 h revealed the highest alginate degrading ability and the lowest pH value. As the incubation time increased, the lightness (L *) also decreased and was measured at its lowest value, 39.84, at 12 hours. The redness and yellowness increased gradually to 10.27 at 6 h and to 63.95 at 3 h, respectively. Moreover, the alginate oligosaccharides exhibited significant anti-inflammatory activity. These results indicate that a crude enzyme from S. oneidensis PKA 1008 can be used to enhance the polysaccharide degradation of UPT and the alginate oligosaccharides may also enhance the anti-inflammatory effect.

Visual Hyper-vigilance But Insufficient Mental Representation in Children with Overweight/Obesity: Event-related Potential Study with Visual Go/NoGo Test.

PURPOSE: The neural processing of children with overweight/obesity (CWO), may affect their eating behavior. We investigated the visual information processing of CWO under response control condition, by event-related potential (ERP) study, an electrophysiologic study for cognitive mechanism. METHODS: Seventeen CWO (mean age: 10.6±1.9), and 17 age-matched non-obese children (NOC), participated in the study. Neurocognitive function tests and visual ERP under Go/NoGo conditions, were implemented. Area amplitudes of major ERP components (P1, N1, P2, N2, and P3) from four scalp locations (frontal, central, parietal, and occipital), were analyzed. RESULTS: For Go and NoGo conditions, CWO had significantly greater occipital P1, fronto-central N1, and P2 amplitudes compared with NOC. P2 amplitude was significantly greater in CWO, than in NOC, at the frontal location. N2 amplitude was not significantly different, between CWO and NOC. For CWO and NOC, Go P3 amplitude was highest at the parietal location, and NoGo P3 amplitude was highest at the frontal location. In Go and NoGo conditions, P3 amplitude of CWO was significantly less than in NOC. CONCLUSION: The greater P1, N1, and P2 suggested hyper-vigilance to visual stimuli of CWO, but the smaller P3 suggested insufficient mental representation of them. Such altered visual processing, may affect the eating behavior of CWO.

Anti-Inflammatory Effects of Grasshopper Ketone from Sargassum fulvellum Ethanol Extract on Lipopolysaccharide-Induced Inflammatory Responses in RAW 264.7 Cells.

This study evaluated the anti-inflammatory potential of a grasshopper ketone (GK) isolated from the brown alga Sargassum fulvellum on lipopolysaccharide (LPS)-induced RAW 264.7 murine macrophage cell line. GK was isolated and purified from the n-hexane fraction and its structure was verified on the basis of NMR spectroscopic data. GK up to 100 µg/ml is not cytotoxic to RAW 264.7, and is an effective inhibitor of LPS-induced NO production in RAW 264.7 cells. The production of pro-inflammatory cytokines, including IL-6, IL-1ß, and TNF-α was found significantly reduced in 0.1-100 µg/ml dose ranges of GK treatment (p < 0.05). We confirmed the dose-dependent and significant inhibition of iNOS and COX-2 proteins expression. In addition, it has been shown that GK induces anti-inflammatory effects by inhibiting MAPKs (ERK, JNK, and p38) and NF-κB p65 phosphorylation. Our results show that the anti-inflammatory properties of GK may be due to the inhibition of the NF-κB and MAPKs pathways, which are associated with the attenuation of cytokine secretion.

Cognitive Function, Emotional and Behavioral Problems, and Temperament of Premature Children.

OBJECTIVES: We aimed to compare preterm, neurodevelopmentally disordered and healthy full-term children. METHODS: We enrolled 47 children who were born preterm, 40 neurodevelopmentally disordered children, and 80 healthy children as control participants, in order to assess the cognitive functioning and the risk of behavioral problems at the age of 5. Children were assessed using the Korean Wechsler Preschool and Primary Scale of Intelligence-4th edition (K-WPPSI-IV), the Child Behavior Checklist (CBCL), and the Temperament and Character Inventory (TCI). RESULTS: The mean K-WPPSI-IV score of the preterm group was 87.19±17.36, which was significantly higher than that of the neurodevelopmental disorder group (69.98±28.63; p<0.001) but lower than that of the control group (107.74±14.21; p<0.001). The cumulative CBCL scores of the preterm children were not significantly different from those of the control group. Additionally, the TCI scores for reward dependence of the preterm children were higher than those of the control group. CONCLUSION: The cognitive performance of preterm infants was lower than that of healthy full-term infants at the age of 5, and there was an association between slower growth and decreased cognitive ability.

Plasma Zonulin Levels in Childhood Nephrotic Syndrome.

Objective: We conducted this study to test the hypothesis that plasma zonulin levels are elevated in pediatric patients with nephrotic syndrome compared to healthy controls. Study Design: Plasma zonulin levels were measured by ELISA in 114 children enrolled in the NEPTUNE study. Clinical and laboratory data were retrieved from the NEPTUNE database. Results: The median age of the patients was 10 (IQR = 5 to 14) years, 59 were male, 64 had minimal change disease, 47 focal segmental glomerulosclerosis, median eGFR was 96 (IQR = 80 to 114) ml/min/1.73 m2, and median urine protein:creatinine ratio was 0.5 (IQR = 0.1 to 3.4) (g:g). The plasma zonulin level was 14.2 ± 5.0 vs. 10.2 ± 2.5 ng/ml in healthy adults in a report using the same assay kit, P = 0.0025. These findings were confirmed in an independent cohort of children with nephrotic syndrome compared to healthy age-matched controls, P = 0.01. Zonulin concentrations did not differ in children with minimal change disease vs. focal segmental glomerulosclerosis, frequently relapsing vs. steroid-dependent vs. steroid-resistant clinical course, and were not influenced by the immunosuppressive treatment regimen. There was no relationship between plasma zonulin levels and the absolute or percentage change in proteinuria from enrollment until the time of the zonulin assay. Conclusion: Plasma zonulin levels are elevated in childhood nephrotic syndrome regardless of level of proteinuria or specific treatment. The cause of the high plasma zonulin levels and whether zonulin contributes to glomerular injury requires further study.

Antioxidant activity of mojabanchromanol, a novel chromene, isolated from brown alga Sargassum siliquastrum.

Silica gel chromatography HPLC, El-Mass, and NMR analyses were performed in order to determine the structure obtained from the separation and refinement of the main components of an ethanol extraction of Sargassum siliquastrum, which indicated its antioxidant activity An ethanol extraction of Sargassum siliquastrum demonstrated the strongest antioxidant activities of ethyl acetate when isolated by silica gel chromatography This amounts to 84.9 +/- 1.2% of its 0.5 mg ml(-1) concentration. The thiobarbituric acid reactive substances (TBARS) measurements from 3 isolations of an HPLC separation of ethyl acetate showed that the antioxidant activity of peak 2 was the most dominant at 84.08% in a 0.5 mg ml(-1) concentration. Peak 2 was verified as a type of chromene through El-Mass and NMR analysis. Its metal sealing characteristic was low while its characteristic of TBARS and DPPH erasure indicated similar or higher levels of metal sealing characteristic. The NMR spectroscopic data was used to elucidate the structure of this new compound, which showed strong antioxidant activity in the assay.

Determining Whether a Dosage-Specific and Individualized Home Exercise Program With Consults Reduces Fall Risk and Falls in Community-Dwelling Older Adults With Difficulty Walking: A Randomized Control Trial.

BACKGROUND AND PURPOSE: The development and implementation of effective interventions to prevent falls in older adults is a public health priority. The purpose of this study was to compare the efficacy of a new practice model, incorporating Shubert's evidence-based fall prevention recommendations, with the usual ambulatory physical therapy (PT) at Rusk Rehabilitation, to decrease fall risk among older adults living in the community. The hypotheses were (1) the proposed program would decrease participants' fall risk, (2) it would be more effective than our usual PT, and (3) the addition of 4 consults after discharge would improve compliance with a home exercise program. METHODS: This was a randomized controlled trial. Sixty-nine participants who were independent community dwellers, were 65 years or older, had difficulty walking or complaints of instability, and had 1 or more risk of falls were randomly assigned into a usual care group (UCG, n = 43) or an experimental group (EG, n = 26). Both groups received PT 2 times per week for 30 minutes for 10 to 32 visits. The UCG received the usual PT delivered at Rusk. The EG was instructed in a moderate- to high-intensity home exercise program designed after completing the mini-Balance Evaluation Systems Test to assist with exercise prescription. The EG was educated on performing a recommended dosage of exercise over 6 months using a diary. The EG received 4 additional 30-minute consults every 2 to 4 weeks postdischarge to reinforce compliance. Self-report of number of falls, number of minutes of exercise per week, and performance on outcome measures (Timed Up and Go, 5-times sit-to-stand, Berg Balance Scale, and Activity Balance Confidence Scale) were monitored at evaluation, 2, 4, and 6 months. RESULTS AND DISCUSSION: Thirty-five participants completed the study (UCG n = 22; EG n = 13). Both groups were similar at baseline on outcome measures and number of visits. Random effect model analyses demonstrated that both groups made significant reductions in fall risk over 6 months as identified by performance on outcome measures. However, the EG improved significantly more compared with the UCG over time (P < .05). Linear regression analyses showed that the EG exercised significantly more compared with the UCG at all times (P < .05). The EG exceeded the target of 115 min/wk of exercise (154 minutes, standard deviation [SD] 68.5; 170 minutes, SD 96.8; and 143 minutes, SD 68.5) at 2, 4, and 6 months, respectively. This study demonstrated that the experimental program is effective in decreasing fall risk in community-dwelling older adults and is more effective than our usual care. Moreover, it suggests that the overall experimental protocol may offer an effective strategy to foster adherence to an exercise program without the increasing number of visits. CONCLUSION: This study supports the efficacy of the experimental program in decreasing fall risk and being more effective than our usual care, as well as fostering greater compliance with an exercise regimen. It provides some preliminary evidence to support Shubert's recommendation on exercise prescription for fall prevention.

Immune-enhancement effects of tuna cooking drip and its enzymatic hydrolysate in Balb/c mice.

Tuna cooking drip (TCD) is a protein rich by-product of canned tuna processing that is typically discarded. In this study, the immune-enhancing activities of TCD and its enzymatic hydrolysate (EH-TCD) were investigated by intraperitoneally administering Balb/c male mice with TCD and EH-TCD for 2 weeks. This administration resulted in an increase in the weight of the spleen and thymus (200-800 mg/kg) and enhanced the proliferation rates of splenocytes (200-800 mg/kg). TCD and EH-TCD significantly increased the production of immunostimulatory cytokines (interleukin-10 and interleukin-2). In addition, TCD and EH-TCD increased serum IgG1 and IgG2a levels in a concentration-dependent manner. Particularly, EH-TCD had a greater immune-enhancing effect than TCD. These results suggest that TCD and EH-TCD exert immune-enhancing effects through an IgG antibody response and T cell activation, and EH-TCD can be used as an immunostimulatory agent.