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Aim: To evaluate the effectiveness of an individualized nutritional education program in promoting adequate nutrient intake in pregnant women. Methods: A stratified randomized controlled trial was conducted. Participants were stratified by factors affecting the primary outcome and randomly assigned to the intervention or control groups. Intervention group participants received an individualized 30‐min booklet‐based education program in their 2nd and 3rd trimesters; the control group received usual care. The primary outcome was protein intake after the intervention, which was compared between the intervention and control groups. Secondary outcomes included comparing the amount of increase of protein before and after the intervention. Nutrient intake was measured using a self‐administered short dietary history questionnaire, and analyses of covariance and t tests were performed. Results: Of the 130 participants, 66 were assigned to the intervention group and 64 to the control group. There was no difference in protein intake between the two groups after the intervention (p =.051, 95% CI [−0.021, 12.4]). Comparing the increase in protein intake before and after intervention, the intervention group was 7.4 g/day higher than that of the control group (p =.040; F = 4.31; effect size = 0.36). Conclusions: The primary outcome, a comparison of protein intake between the groups after the program, revealed no significant differences. However, on comparing the amount of protein increase before and after the intervention, the intervention group's increase was significantly higher than that of the control group. Results indicate the potential for individualized face‐to‐face interventions for pregnant women in Japan. [ABSTRACT FROM AUTHOR]

Introduction: Previous studies have shown that musical instrument training programs of 16 or more weeks improve verbal memory (Logical Memory Test delayed recall), processing speed (Digit Symbol Coding Test), and executive function (Trail Making Test Part B) of musically untrained healthy older adults. However, it is unclear whether shorter-period instrument training can yield similar effects. We sought to (1) verify those results and (2) clarify if intervention effects could be detected using other measures such as reaction time. Methods: Healthy older adults (mean age = 73.28 years) were pseudo-randomly assigned to an untrained control group (n = 30) or an intervention group (n = 30) that received a weekly 10-session musical instrument training program (using melodica). We conducted neuropsychological tests on which intervention effects or association with musical training were reported in previous studies. We newly included two reaction time tasks to assess verbal working memory (Sternberg task) and rhythm entrainment (timing task). Intervention effects were determined using a "group x time" analysis of variance (ANOVA). Results: The intervention effects were detected on the reaction time in Sternberg task and phonological verbal fluency. Although intervention effects had been reported on Logical Memory test, Digit Symbol Coding Test and Trail Making Test in previous studies with longer training periods, the present study did not show such effects. Instead, the test-retest practice effect, indicated by significant improvement in the control group, was significant on these tests. Discussion: The present results indicated the usefulness of working memory assessments (Verbal Fluency Test and Sternberg task) in detecting the effects of short-term melodica training in healthy older adults. The practice effect detected on those three tasks may be due to the shorter interval between preand post-intervention assessments and may have obscured intervention effects. Additionally, the findings suggested the requirement for an extended interval between pre- and post-tests to capture rigorous intervention effects, although this should be justified by a manipulation of training period. [ABSTRACT FROM AUTHOR]

Background: More new randomized controlled trials (RCTs) on acupuncture have been published in Japan since our last updated systematic review (2010). This systematic review aimed to evaluate the quality of RCTs on acupuncture conducted in Japan and understand the decade-wise changes in the methodological characteristics of the relevant RCTs. Methods: The literature search was performed using Ichushi Web, the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed and our team's compilation of relevant papers. We included full-length papers reporting RCTs that examined the clinical effects of acupuncture on patients in Japan published in or before 2019. We assessed the risk of bias (RoB), sample size, control setting, negative trial reporting, informed consent, ethics approval, trial registration, and adverse event reporting. Results: A total of 99 articles reporting 108 eligible RCTs were identified. The number of RCTs published in each decade was 1, 6, 9, 5, 40, and 47 in the 1960s, 1970s, 1980s, 1990s, 2000s, and 2010s, respectively. Quality assessment using the Cochrane RoB tool revealed that "sequence generation" improved in and after 1990 (73%–80% of RCTs were rated as "low") and "blinding of outcome assessors" slightly improved in and after the 2000s (40%–50% judged as "low"). However, "high" or "unclear" remained the dominant grades in other domains. Clinical trial registration and adverse events were reported only in 9% and 28% of the included RCTs even in the 2010s, respectively. A different acupuncture method or different point selection (e.g., deep vs. shallow insertion) was the most dominant control setting before 1990, while sham (or "placebo") needling and/or sham acupoints became the most dominant in the 2000s. The proportion of RCTs with positive results was 80% in the 2000s and 69% in the 2010s. Conclusions: The quality of RCTs on acupuncture conducted in Japan did not appear to have improved over the decades except for "sequence generation." While the culture of submitting negative trial reports was prevalent in the Japanese acupuncture research milieu as late as the 1990s, the overall quality of the relevant trials needs to be further improved. [ABSTRACT FROM AUTHOR]

Aim: Radio‐Taiso, a traditional exercise program in Japan, may serve as a coping strategy for older adults with frailty during the COVID‐19 pandemic. This phase II trial tested program adherence and safety and explored the potential effectiveness of a home‐based Radio‐Taiso. Methods: This assessor‐blind parallel randomized controlled trial included community‐dwelling Jolder Japanese adults with frailty and pre‐frailty. Fifty‐eight eligible participants were randomly allocated to intervention and control groups. Intervention participants performed 3–5‐min sessions of Radio‐Taiso one to four times per day for 12 weeks. Feasibility criteria were set at practice and retention rates of ≥75%. Safety was monitored by assessing all adverse events reported by participants during the intervention period, irrespective of causality. Potential effectiveness was exploratorily assessed using items that allow clinical interpretation of changes: mobility and health‐related quality of life (HR‐QoL), assessed using the modified short physical performance battery (SPPB) and the SF‐36, respectively. Results: Both practice (83%) and retention rates (100%) met the predetermined feasibility criteria. Eleven adverse events were reported but were supposedly unrelated to the intervention. In the intention‐to‐treat analysis, there was no clinically significant difference in the change in SPPB score between groups (−0.4 points, 95% confidence interval [CI], −1.2, 0.3); however, the intervention group scored higher in the mental component of HR‐QoL than did the control group (3.4 points, 95% CI: −1.1, 7.8). Conclusions: The preliminary data indicate that a phase III trial is feasible, focusing on the mental aspect of HR‐QoL as the primary outcome. Geriatr Gerontol Int 2023; 23: 32–37. [ABSTRACT FROM AUTHOR]

Aim: Hiesho is a condition characterized by having a cold sensation in the hands or feet (i.e., sensitivity of the hands or feet to cold). This condition is common among Japanese women and is an important health problem. In this study, we aimed to evaluate a hiesho intervention program for nurses called "Preventing Hiesho: Intervention Program for Educating Nurses" in terms of its effectiveness in improving the knowledge and perceptions of nurses about the importance of hiesho care. Methods: A total of 130 nurses from Japanese hospitals and clinics providing prenatal care participated in our randomized controlled trial. Sixty‐eight nurses participated in the "Preventing Hiesho: Intervention Program for Educating Nurses" for 2 weeks (intervention group). Sixty‐two nurses received a pamphlet on hiesho care (control group). The responses of the participants to the questionnaire survey were collected by postal mail. An intention‐to‐treat analysis of the results was conducted. Results: One week after the implementation of the web‐based learning program, the scores of knowledge and perceptions of the importance of administering hiesho care were significantly higher in the intervention group than in the control group. Conclusions: A 2‐week web‐based learning program for educating nurses on preventing hiesho significantly improved their knowledge and perceptions of the importance of hiesho care. [ABSTRACT FROM AUTHOR]

Objective: The purpose of this study was to develop and evaluate the effectiveness of using e‐learning on smartphones to provide dental hygiene education on dental treatment procedures. Methods: This was a randomized controlled trial. Two‐hundred ninety‐three dental hygiene students in four universities, one junior college and one technical school took a preliminary examination, and based on the results, participants in each school were randomly divided into two groups, a test or control group. Both groups took pre‐ and post‐examinations at a 4‐week interval. The test groups learned dental treatment procedures and four‐handed techniques with interactive learning materials using smartphones. The learning materials allowed them to watch videos of dental treatments. The control groups were not provided any learning material. Results: Results of all schools combined showed that the changes from pre‐ to post‐examination scores in the test groups were significantly higher than those of the control groups (p <.05). Post‐examination scores were significantly higher than pre‐examination scores in the test groups in all schools (p <.05). Also, post‐examination scores of the test groups were significantly higher than those of the control groups (p <.05). The changes from pre‐ to post‐examination scores in the test groups of two schools were significantly higher than those of control groups (p <.05). Post‐examination scores of the control groups in two schools were significantly higher than pre‐examination scores (p <.05). Conclusions: Learning dental treatment procedures through e‐learning on a smartphone was effective in developing participants' understanding of dental treatment procedures and four‐handed techniques. [ABSTRACT FROM AUTHOR]

Summary: A 48-week, multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority trial (the TWICE study) conducted in Japanese primary osteoporosis patients with a high risk of fractures demonstrated that a 28.2-μg twice-weekly regimen of teriparatide can provide comparable efficacy to a 56.5-μg once-weekly regimen of teriparatide, while also improving safety. Introduction: While a 56.5-μg once-weekly regimen of teriparatide has high efficacy for osteoporosis, treatment continuation rates are low, with one of the major causes being adverse drug reactions such as nausea or vomiting. The TWICE study was therefore conducted to investigate whether a twice-weekly regimen with 28.2-μg teriparatide can provide comparable efficacy to the 56.5-μg once-weekly regimen while improving safety. Methods: A 48-week, multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority trial was conducted in Japan. Patients with primary osteoporosis aged ≥ 65 years at high risk of fractures (n = 553) were randomly allocated to the 28.2-μg twice-weekly group (n = 277) or the 56.5-μg once-weekly group (n = 276). The primary endpoint was the percentage change in lumbar spine (L2–L4) bone mineral density (BMD) at final follow-up. Results: The percentage changes in lumbar spine (L2–L4) BMD at final follow-up in the 28.2-μg twice-weekly and 56.5-μg once-weekly groups were 7.3% and 5.9%, respectively; the difference (95% confidence interval [CI]) in percentage change was 1.3% (0.400–2.283%). Since the lower limit of the 95% CI was above the pre-specified non-inferiority margin (− 1.6%), non-inferiority of the 28.2-μg twice-weekly group was demonstrated. Adverse drug reactions were significantly less frequent in the 28.2-μg twice-weekly group (39.7% vs 56.2%; p < 0.01); the incidence of major adverse drug reactions was lower, and the number of subjects who discontinued due to adverse drug reactions was less in the 28.2-μg twice-weekly group. Conclusions: A 28.2-μg twice-weekly regimen of teriparatide can provide comparable efficacy to a 56.5-μg once-weekly regimen while improving safety. Clinical trial registration: JapicCTI-163477. [ABSTRACT FROM AUTHOR]

Objective: To verify the effect of adjusting the challenge–skill balance with respect to rehabilitation process. Design: A single-blind, two-arm, parallel-group, randomized controlled trial. Setting: Recovery rehabilitation unit of Harue Hospital, Japan. Subjects: The trial included 72 clients (mean (SD): age, 74.64 (9.51) years; Functional Independence Measure score, 98.26 (15.27)) with cerebral or spinal disease or musculoskeletal disease. Interventions: Clients were randomly divided into two groups: the experimental group, who received occupational therapy with adjustment of the challenge–skill balance, and the control group who received conventional occupational therapy. Time from admission to discharge was considered the implementation period; the final evaluation was conducted at three months after discharge. Main measures: The primary outcome was subjective quality of life (Ikigai-9). Secondary outcomes were the health-related quality of life (EuroQol–5 Dimensions, Five Levels (EQ-5D-5L)), the Flow State Scale for Occupational Tasks, and the Functional Independence Measure. A cost-effectiveness analysis was conducted using total cost and quality-adjusted life-year based on the EQ-5D-5L. Results: Significant differences were observed between the experimental and control groups with respect to the Ikigai-9 score (P = 0.008) and EQ-5D-5L (P = 0.038), and the effect sizes were 0.76 (95% confidence interval [CI]: 0.27–1.24) and 0.62 (95% CI: 0.14–1.10), respectively. No significant between-group differences in other outcomes were observed, for example, the Functional Independence Measure score improved in both experimental and control groups (119.80 (5.50) and 118.84 (6.97), respectively. The incremental cost-effectiveness ratio was US$5518.38. Conclusions: Adjusting the challenge–skill balance may be a useful approach to improve the participant's subjective quality of life in the rehabilitation process. [ABSTRACT FROM AUTHOR]

Objectives: To evaluate the effect of a self-controlled vocal exercise in elderly people with glottal closure insufficiency. Design: Parallel-arm, individual randomized controlled trial. Methods: Patients who visited one of 10 medical centers under the National Hospital Organization group in Japan for the first time, aged 60 years or older, complaining of aspiration or hoarseness, and endoscopically confirmed to have glottal closure insufficiency owing to vocal cord atrophy, were enrolled in this study. They were randomly assigned to an intervention or a control group. The patients of the intervention group were given guidance and a DVD about a self-controlled vocal exercise. The maximum phonation time which is a measure of glottal closure was evaluated, and the number of patients who developed pneumonia during the six months was compared between the two groups. Results: Of the 543 patients enrolled in this trial, 259 were allocated into the intervention group and 284 into the control; 60 of the intervention group and 75 of the control were not able to continue the trial. A total of 199 patients (age 73.9 ±7.25 years) in the intervention group and 209 (73.3 ±6.68 years) in the control completed the six-month trial. Intervention of the self-controlled vocal exercise extended the maximum phonation time significantly (p < 0.001). There were two hospitalizations for pneumonia in the intervention group and 18 in the control group, representing a significant difference (p < 0.001). Conclusion: The self-controlled vocal exercise allowed patients to achieve vocal cord adduction and improve glottal closure insufficiency, which reduced the rate of hospitalization for pneumonia significantly. Clinical Trial.gov Identifier-UMIN000015567 [ABSTRACT FROM AUTHOR]

Objective: To assess differences in improvement of hiesho (sensitivity to cold) through a randomized controlled trial (RCT) of one group that used a self-care program (the Home Care Package Program for Relieving Hiesho) and another that did not. Methods: Participants were pregnant women experiencing hiesho in the 28th to 33rd weeks of pregnancy. The group carried out the intervention program for 4 weeks by wearing leg warmers, performing exercises, and pressing acupuncture points. The control group did not take any specific actions. Hiesho condition was assessed by using thermography to measure temperature in the four limbs; the changes were analyzed. Results: Findings for 140 pregnant women (73 in the experimental group and 67 in the control group) were analyzed. Participants' body temperatures were measured after completion of the program for 4 weeks and compared to their temperatures before start of the program. Compared with the control group, the experimental group had arm skin temperature 3.0°C ( p < 0.001) higher and leg skin temperature 1.93°C ( p = 0.02) higher; both differences were significant. Conclusion: The Home Care Package Program for Relieving Hiesho self-care program significantly relieved hiesho. [ABSTRACT FROM AUTHOR]

We examined the effects of home-based walking on sedentary Japanese women's pregnancy outcomes and mood. A randomized controlled trial was conducted, involving 118 women aged 22-36 years. Participants were randomly assigned to walking intervention ( n = 60) or control ( n = 58) groups. The walking group was instructed to walk briskly for 30 min, three times weekly from 30 weeks' gestation until delivery. Both groups counted their daily steps using pedometers. Pregnancy and delivery outcomes were assessed, participants completed the Profile of Mood States, and we used the intention-to-treat principle. Groups showed no differences regarding pregnancy or delivery outcomes. The walking group exhibited decreased scores on the depression-dejection and confusion subscales of the Profile of Mood States. Five of the 54 women in the intervention group who remained in the study (9.2%) completed 100% of the prescribed walking program; 32 (59.3%) women completed 80% or more. Unsupervised walking improves sedentary pregnant women's mood, indicating that regular walking during pregnancy should be promoted in this group. [ABSTRACT FROM AUTHOR]

Objectives To investigate whether a 12-week physical and cognitive exercise program can improve cognitive function and brain activation efficiency in community-dwelling older adults. Design Randomized controlled trial. Setting Kyoto, Japan. Participants Community-dwelling older adults (N = 48) were randomized into an exercise group (n = 24) and a control group (n = 24). Intervention Exercise group participants received a weekly dual task-based multimodal exercise class in combination with pedometer-based daily walking exercise during the 12-week intervention phase. Control group participants did not receive any intervention and were instructed to spend their time as usual during the intervention phase. Measurements The outcome measures were global cognitive function, memory function, executive function, and brain activation (measured using functional magnetic resonance imaging) associated with visual short-term memory. Results Exercise group participants had significantly greater postintervention improvement in memory and executive functions than the control group ( P < .05). In addition, after the intervention, less activation was found in several brain regions associated with visual short-term memory, including the prefrontal cortex, in the exercise group ( P < .001, uncorrected). Conclusion A 12-week physical and cognitive exercise program can improve the efficiency of brain activation during cognitive tasks in older adults, which is associated with improvements in memory and executive function. [ABSTRACT FROM AUTHOR]

Objectives: A randomized controlled trial was conducted to evaluate the efficacy of impedance control of a radiofrequency interstitial thermal ablation system (RITA) used to treat hepatocellular carcinoma (HCC). Methods: Fifteen patients with hypervascular HCCs <20 mm in diameter were randomly treated with radiofrequency ablation (RFA) using conventional temperature control (group A) or impedance control methods (group B). RITA needle electrodes were used in all cases. We compared ablation time, extent of lesion ablation, and energy use between the two groups. Results: The median long and short diameters of the axial cross sections of radiofrequency-induced necrotic areas visualized by CT were 32 mm (range, 26-36) and 25 mm (20-31) in group A and 32 mm (28-40) and 31 mm (24-37) in group B, respectively. The short diameter of group B patients was significantly greater than that of group A patients (p = 0.029). The median ablation time was 18.8 min in group A and 13.4 min in group B, thus significantly shorter in group B (p = 0.001). The energy requirement did not differ significantly between the groups. Conclusions: Impedance control of the RITA system resulted in an increased size of the ablation zone and a decreased ablation time. © 2015 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Background: In double-bundle (DB) anterior cruciate ligament (ACL) reconstruction, no consensus exists on an optimal setting for the posterolateral bundle (PLB) graft fixation angles. Hypothesis: Different PLB fixation angles would affect clinical outcomes in DB ACL reconstruction. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: This study prospectively included 90 patients who underwent primary DB ACL reconstruction with an autologous semitendinosus tendon. The PLB fixation angles were randomly set as follows: 0 of flexion (P0; n = 30), 20 (P20; n = 30), and 45 (P45; n = 30). In all groups, the anteromedial bundle was fixed at 20 of flexion. The following evaluation methods were used at the preoperative period and at 3, 6, and 9 months and 1 and 2 years after the surgery: clinical examination, KT-1000 arthrometer measurement, muscle strength, Tegner score, Lysholm score, and subjective rating scale regarding patient satisfaction and sports performance levels. Graft retear, contralateral ACL tear, and additional meniscus surgery were also recorded. Results: Seventy-five patients (P0, n = 25; P20, n = 26; P45, n = 24) who were followed for 2 years were evaluated. Preoperatively, there were no differences among the groups. Postoperatively, pivot-shift test results in the P0 and P20 groups were better than those in the P45 group (P0, n = 23 graded negative and 2 graded 11; P20, n = 23 and 2; P45, n = 15 and 7, respectively; P0 vs P45: P = .038 and P20 vs P45: P = .038). Average KT-1000 arthrometer laxity measurements were better in the P20 group than in the P45 group (P0, 0.4 mm; P20, 0.3 mm; P45, 1.3 mm; P20 vs P45: P = .048), and there were more patients with graft failure (KT-1000 measurement, 4 mm) in the P45 group (n = 3) than the P0 and P20 groups (each, n = 0). There were no significant differences in range of motion, other laxity tests, muscle strength, Tegner score, Lysholm score, subjective rating scale, or additional surgery. Conclusion: In DB ACL reconstruction, when the anteromedial bundle was fixed at 20 of flexion, fixation of the PLB at 45 was worse than fixation at 0 and 20 with respect to anterior and rotational stability during the 2-year follow-up. KT-1000 arthrometer measurements and pivot-shift test results were significantly worse, and there were more patients with graft failure in the P45 group. There were no differences among groups in other findings. [ABSTRACT FROM AUTHOR]

The article discusses a study on the effectiveness of balance training performed using a foam rubber pad in improving balance and reducing the number of falls of study participants. Topics discussed include the participants' 60-weekly exercise class for 4 months supplemented with daily home-based exercises and findings that a balance training program was effective for improving physical function in community-dwelling older adults.

Background The efficacy of disulfiram in preventing an alcoholic relapse has been controversial. The aim of our study was to assess the efficacy of supervised disulfiram for the treatment of alcohol dependence with a multi-institutional study in Japan. Methods In a single-blinded, randomized placebo-controlled study, we recruited 109 patients diagnosed with alcohol dependence under ICD-10 criteria. The patients were randomly allocated to 4 treatment groups, depending on whether they took disulfiram (200 mg daily) or a placebo or whether they received adjunctive therapy consisting of mailed letters which delineated and emphasized the harmful effect of alcohol and the management of alcohol craving. The proportion of abstinence among the 4 groups at 26 weeks after discharge was the primary outcome measure. The proportion of abstinence was compared with the severity of alcohol dependence and craving. Furthermore, we examined the proportion of abstinence in patients with inactive aldehyde dehydrogenase-2 ( ALDH2). Results There were no significant differences among the 4 groups in terms of abstinent patients or study dropouts. The ratio of abstinence was not related to the severity of alcohol dependence or the degree of alcohol craving. Patients with inactive ALDH2 significantly sustained abstinence with the use of disulfiram ( p = 0.044). Conclusions Supervised oral disulfiram use followed by intervention via letters seems to be ineffective for increasing abstinence. Further studies are necessary to prove the efficacy of disulfiram for the pharmacological treatment of alcohol dependence. We indicated the effectiveness of disulfiram for the maintenance of abstinence in patients with inactive ALDH2. [ABSTRACT FROM AUTHOR]

Background To elucidate whether maternal vitamin D supplementation during lactation improves infantile eczema and other subsequent allergic disorders, a randomized, double-blind, placebo-controlled trial was performed. Methods Mothers ( n = 164) of infants with facial eczema at 1 month check-up were randomly assigned to receive vitamin D3 supplements ( n = 82; 800 IU/day) or placebo ( n = 82) for 6 weeks from May 2009 to January 2011. The primary outcome was infantile eczema quantified on Scoring Atopic Dermatitis ( SCORAD) index at 3 month check-up, and the secondary outcomes were atopic dermatitis, food allergy, and wheeze diagnosed by doctors up to 2 years of age. Results There was no significant difference in SCORAD at 3 month check-up between the two groups. Doctor-diagnosed food allergy was significantly more common up to age 2 years in the vitamin D group (10/39, 25.7%) than in the placebo group (3/40, 7.5%; risk ratio (RR), 3.42; 95% confidence interval [CI]: 1.02-11.77; P = 0.030). Moreover, at least one secondary outcome was also significantly more common in the vitamin D group (17/39, 43.6%) than in the placebo group (7/40, 17.5%; RR, 2.49; 95% CI: 1.16-5.34; P = 0.012). Conclusions Vitamin D supplementation may not decrease the severity of infantile eczema at 3 months of age, but may rather increase the risk of later food allergy up to 2 years of age. Because a large number of subjects was lost to follow up, further study is needed to confirm the findings. [ABSTRACT FROM AUTHOR]

Aim The objective of this study was to evaluate the effects of a comprehensive overweight intervention program, which utilizes hot bathing, on overweight, community-dwelling middle-aged and older adults in a randomized controlled trial. Methods The program was carried out in a hot bath facility and included 66 community-dwelling middle-aged and older Japanese adults (mean age 61.6 years, SD 7.5, 77.3% were women). The participants were randomly assigned to an exercise, diet and hot bathing intervention group (group A), exercise and diet intervention group (group B), a hot-bathing intervention group (group C) and a control group (group D). The participants in groups A and B participated in a comprehensive intervention program (including exercise and diet classes) twice a week for 3 months, and groups A and C had hot bathing. Results After 3 months, the participants in group A showed a reduction in weight, abdominal circumference, body mass index and body fat percentage compared with the other intervention groups. And the lower extremity function (i.e. walking speed) had greater improvement in the participants in groups A and B compared with groups C and D. In group C, in which only hot bathing was the intervention, there were no significant improvements in measurement items. Conclusions Our study provides preliminary evidence that a comprehensive intervention program, including hot bathing, is useful for community residents with a tendency toward overweight. Geriatr Gerontol Int 2013; 13: 638-645. [ABSTRACT FROM AUTHOR]

Objective. To evaluate the prevention of joint destruction and clinical efficacy of low-dose etanercept (ETN) (25 mg/week) compared with standard-dose ETN (50 mg/week) in RA.Methods. In this prospective, randomized, open-label study, 70 patients were assigned to receive ETN at either 50 or 25 mg/week for 52 weeks. The primary endpoint was the variation in modified total Sharp score (mTSS), and secondary endpoints were variations in disease activity score in 28 joints (DAS-28), modified HAQ and adverse event rate. Values of mTSS were calculated at baseline and after 52 weeks. Non-progression was estimated as ΔmTSS &leq;0.5, and the non-progression rate was compared between groups.Results. Mean values at baseline were as follows: disease duration 9.2 years; DAS-28 5.45; and annual progression of mTSS 26.1. No significant differences in background were seen between groups. At 52 weeks, the non-progression rate was significantly less in the 25 mg/week group (36.7%) than in the 50 mg/week group (67.7%) (P = 0.041). Mean ΔmTSS was higher at 25 mg/week (1.03) than at 50 mg/week (−0.13). DAS-28 was significantly improved at 4 weeks, and the effect of treatment lasted for 52 weeks in both groups. No differences in adverse event rates were seen between groups.Conclusion. Low-dose ETN is not inferior to standard-dose ETN in terms of effects on clinical manifestations. However, in terms of the radiographic non-progression rate, the effects of low-dose ETN may be inferior to the effects of standard-dose ETN.Trial Registration: UMIN Clinical Trials Registry, http://www.umin.ac.jp/ctr/, UMIN000001798. [ABSTRACT FROM PUBLISHER]

Abstract: Social isolation among the elderly is a concern in developed countries. Using a randomized trial, this study examined the effect of a social isolation prevention program on loneliness, depression, and subjective well-being of the elderly in Japan. Among the elderly people who relocated to suburban Tokyo, 63 who responded to a pre-test were randomized and assessed 1 and 6 months after the program. Four sessions of a group-based program were designed to prevent social isolation by improving community knowledge and networking with other participants and community “gatekeepers.” The Life Satisfaction Index A (LSI-A), Geriatric Depression Scale (GDS), Ando-Osada-Kodama (AOK) loneliness scale, social support, and other variables were used as outcomes of this study. A linear mixed model was used to compare 20 of the 21 people in the intervention group to 40 of the 42 in the control group, and showed that the intervention program had a significant positive effect on LSI-A, social support, and familiarity with services scores and a significant negative effect on AOK over the study period. The program had no significant effect on depression. The findings of this study suggest that programs aimed at preventing social isolation are effective when they utilize existing community resources, are tailor-made based on the specific needs of the individual, and target people who can share similar experiences. [Copyright &y& Elsevier]

Background: The authors developed a novel technique to improve tendon-bone healing by hybridizing calcium phosphate (CaP) with a tendon graft using an alternating soaking process. Hypothesis: Anterior cruciate ligament (ACL) reconstruction using the CaP-hybridized tendon graft would have a better clinical outcome and reduce the percentage of bone tunnel enlargement compared with a conventional method because of the enhanced anchoring between the tendon graft and the bone. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Patients (N = 64) with unilateral ACL rupture underwent arthroscopically assisted single-bundle ACL reconstruction using a 4-strand semitendinosus tendon or 4-strand semitendinosus and gracilis tendons with EndoButton femoral fixation and screw washer tibial fixation. These patients were equally randomized to undergo the CaP (n = 32) or conventional (n = 32) method using a transtibial tunnel approach according to the closed envelope method. In the CaP group, the tendon graft was hybridized with the CaP at both ends of the graft. One surgeon performed all reconstructions without knowing which graft was prepared. Patients’ backgrounds regarding age at surgery, gender, period before surgery, and associated meniscal injuries were similar in the 2 groups. All patients followed the same postoperative protocol. At 1 and 2 years after surgery, they were evaluated with the manual knee laxity test, KT-1000 arthrometry, International Knee Documentation Committee (IKDC) examination form, Tegner scale, and Lysholm scale. Also, 1 year postoperatively, bone tunnel enlargement was analyzed using computed tomography, intensity of the tendon graft by magnetic resonance imaging (MRI), and tendon graft appearance by arthroscopic examination. All the examinations were performed blindly. Results: All patients underwent a minimum 2-year follow-up. KT-1000 arthrometry data indicated statistically significant decreased average anterior tibial translation in the CaP group compared with the conventional method group: 1.0 6 2.0 mm versus 1.9 6 1.6 mm (P\.05), respectively, at 1 year; 1.6 6 2.1 mm versus 2.6 6 2.4 mm (P\.05), respectively, at 2 years. The Lysholm score was higher in the CaP group than in the conventional method group at 2 years (96.9 6 4.3 vs 91.7 6 13.3, P\.05). The CaP-hybridized tendon graft reduced the percentage of bone tunnel enlargement of the anteroposterior diameter at the main joint aperture site 1 year postoperatively (femoral side: 15.5% 6 13.4% vs 22.1% 6 16.4%, P\.05; tibial side: 19.3% 6 17.1% vs 26.1% 6 13.7%, P\.05). The results of the pivot-shift test, IKDC grade, and Tegner score; the intensity of the tendon graft (MRI); and arthroscopic appearance were not significantly different at both follow-up periods in the 2 groups. Conclusion: The CaP-hybridized tendon graft improved anterior knee stability and Lysholm scores at the 2-year follow-up and improved anterior knee stability and reduced the percentage of bone tunnel enlargement in both tunnels at the 1-year follow-up compared with the conventional method for single-bundle ACL reconstruction. However, longer follow-up is needed to investigate the appearance of any increased instability. [ABSTRACT FROM AUTHOR]

Objectives: The aim of the present study was to evaluate whether a complex course obstacle negotiation exercise (CC), a 24-week exercise program, can reduce falls and fractures in older adults, as compared with a simple course obstacle negotiation exercise (SC). Methods: This trial was carried out on older adults, aged 75 years and above in Japan. In total, 157 participants were randomized into the CC group ( n = 78) and the SC group ( n = 79). Participants were enrolled in the exercise class using the CC program or the SC program for 24 weeks. The outcome measure was the number of falls and fracture rates in CC and SC groups for 12 months after the completion of the 24-week exercise class. Results: Two participants (2.8%) in the CC group and 19 (26.0%) in the SC group experienced falls during 12 months. During the 12-month follow-up period after the intervention, the incidence rate ratio (IRR) of falls in the SC group against the CC group was 9.37 (95% CI = 2.26-38.77). One participant (1.4%) in the CC group and eight (10.9%) in the SC group had experienced fractures during 12 months after the exercise class. The IRR of fractures in the SC group compared with the CC group was 7.89 (95% CI = 1.01-61.49). Conclusions: The results of the present trial show that the participants who received individualized obstacle avoidance training under complex tasks combined with a traditional intervention had a lower incidence rate of falls and fractures during the 12 months after the intervention. Geriatr Gerontol Int 2012; 12: 461-467. [ABSTRACT FROM AUTHOR]