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Yoshihiro Fukumoto,1,2 Masashi Taniguchi,2 Tetsuya Hirono,2 Masahide Yagi,2 Momoko Yamagata,1,2 Ryusuke Nakai,3 Yosuke Yamada,4 Misaka Kimura,5 Noriaki Ichihashi2 1Faculty of Rehabilitation, Kansai Medical University, Hirakata, Japan; 2Human Health Sciences, Graduate School of Medicine, Kyoto University, Kyoto, Japan; 3Kyoto University Institute for the Future of Human Society, Kyoto, Japan; 4National Institute of Health and Nutrition, National Institutes of Biomedical Innovation, Health, and Nutrition, Tokyo, Japan; 5Institute for Active Health, Kyoto University of Advanced Science, Kameoka, JapanCorrespondence: Yoshihiro Fukumoto, Faculty of Rehabilitation, Kansai Medical University, 18– 89 Uyamahigashicho, Hirakata City, Osaka, 573-1136, Japan, Tel +81-72-856-2307, Fax +81-72-856-2150, Email fukumoty@hirakata.kmu.ac.jpPurpose: This study aimed to investigate the association of muscle thickness (MT) and echo intensity (EI) obtained at different regions along the muscle length with muscle volume (MV), intramuscular adipose tissue (IntraMAT), and muscle strength of the quadriceps femoris (QF).Patients and Methods: A total of 135 community-dwelling adults (64 men and 71 women) participated in the study. Ultrasound scanning of the rectus femoris (RF) and vastus intermedius (VI) was performed at three locations (from mid- to distal thigh). The MT of the RF and VI and EI of the RF were measured. MRI-derived MV, IntraMAT, and muscle strength of the QF were measured.Results: The correlation between RF-MT and RF-MV weakened as scanning approached the distal thigh, and the difference between the coefficients for the scanning locations was significant for women. However, the correlation of VI-MT with VI-MV and that of the combined MT of RF and VI with the MV of the whole QF and muscle strength were comparable among the scanning locations for both sexes. The correlation of RF-EI with the IntraMAT of the RF and the whole QF and muscle strength was also comparable among the scanning locations for both sexes.Conclusion: The results of this study suggest that ultrasound measurements at the distal thigh can predict MV, IntraMAT, and muscle strength of the QF to the same degree as those at the mid-thigh.Keywords: ultrasound scanning, rectus femoris, thigh, muscle strength, MRI

Keita Suzuki,1 Hiromasa Tsujiguchi,1– 3 Akinori Hara,1– 3 Oanh Kim Pham,1 Sakae Miyagi,3,4 Thao Thi Thu Nguyen,5 Haruki Nakamura,1 Fumihiko Suzuki,2,6 Tomoko Kasahara,2 Yukari Shimizu,7 Yohei Yamada,2 Yasuhiro Kambayashi,8 Hirohito Tsuboi,9 Takehiro Sato,3,10 Takayuki Kannon,3,10 Kazuyoshi Hosomichi,3,10 Atsushi Tajima,3,10 Toshinari Takamura,11 Hiroyuki Nakamura1– 3 1Department of Hygiene and Public Health, Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kanazawa, Ishikawa, Japan; 2Department of Public Health, Graduate School of Advanced Preventive Medical Sciences, Kanazawa University, Kanazawa, Ishikawa, Japan; 3Kanazawa University Advanced Preventive Medical Sciences Research Center, Kanazawa, Ishikawa, Japan; 4Innovative Clinical Research Center, Kanazawa University, Kanazawa, Ishikawa, Japan; 5Department of Epidemiology, Faculty of Public Health, Haiphong University of Medicine and Pharmacy, Hai Phong, Vietnam; 6Community Medicine Support Dentistry, Ohu University Hospital, Koriyama, Fukushima, Japan; 7Department of Nursing, Faculty of Health Sciences, Komatsu University, Komatsu, Ishikawa, Japan; 8Department of Public Health, Faculty of Veterinary Medicine, Okayama University of Science, Imabari, Ehime, Japan; 9Institute of Medical, Pharmaceutical, and Health Sciences, Kanazawa University, Kanazawa, Ishikawa, Japan; 10Department of Bioinformatics and Genomics, Graduate School of Advanced Preventive Medical Sciences, Kanazawa University, Kanazawa, Ishikawa, Japan; 11Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Ishikawa, JapanCorrespondence: Keita Suzuki, Department of Hygiene and Public Health, Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, 13-1, Takara-machi, Kanazawa, Ishikawa, 920-8640, Japan, Tel +81 76 265 2218, Fax +81 76 234 4233, Email ksuzuk@staff.kanazawa-u.ac.jpBackground: Previous studies examined the association between chronic pain (CP) and serum 25-hydroxyvitamin D (25(OH)D) concentrations; however, the findings obtained were inconsistent. Single nucleotide polymorphisms (SNP) associated with the transcriptional activity of the vitamin D receptor (VDR) gene may influence the association of 25(OH)D levels with CP. We aimed to clarify the association between CP, serum 25(OH)D concentration, and SNPs.Methods: In the Shika study, we performed a cross-sectional analysis of 551 participants older than 40 years who were asked whether they had been having persistent pain lasting for at least 3 months in any part of the body on a self-administered questionnaire. Serum 25(OH)D concentrations were assessed as a biomarker of the vitamin D status using a radioimmunoassay. rs731236, rs7975232, rs1544410, rs2228570, and rs11568820 were identified using peripheral blood samples, and participants were assigned to those with or without the minor allele for each SNP.Results: The prevalence of CP was 37.2%. We observed a tendency for lower 25(OH)D levels in participants with CP than in those without CP in the hetero/minor group of rs11568820, which is a polymorphism within the CDX2-binding site in the 1e promoter region of the VDR gene. Furthermore, a logistic regression analysis revealed that lower serum 25(OH)D concentrations were significantly associated with CP in the hetero/minor group, but not in the major group.Conclusion: These results suggest that sufficient serum 25(OH)D concentration reduces the risk of CP in individuals with the minor allele of the CDX2 polymorphism.Keywords: chronic pain, 25-hydroxyvitamin D, vitamin D receptor gene, promoter, polymorphism, epidemiology

Yoshihiro Fukumoto,1,2 Tome Ikezoe,2 Masashi Taniguchi,2 Yosuke Yamada,3 Shinichiro Sawano,4 Seigo Minani,5 Tsuyoshi Asai,6 Misaka Kimura,7,8 Noriaki Ichihashi2 1Department of Physical Medicine and Rehabilitation, Kansai Medical University, Hirakata, Japan; 2Human Health Sciences, Graduate School of Medicine, Kyoto University, Kyoto, Japan; 3National Institute of Health and Nutrition, National Institutes of Biomedical Innovation, Health and Nutrition, Tokyo, Japan; 4Rehabilitation Units, Shiga University of Medical Science Hospital, Otsu, Japan; 5Faculty of Rehabilitation, Osaka Kawasaki Rehabilitation University, Kaizuka, Japan; 6Faculty of Rehabilitation, Kobe Gakuin University, Kobe, Japan; 7Institute for Active Health, Kyoto University of Advanced Science, Kameoka, Japan; 8Graduate School of Nursing, Doshisha Women’s College of Liberal Arts, Kyotanabe, JapanCorrespondence: Yoshihiro FukumotoDepartment of Physical Medicine and Rehabilitation, Kansai Medical University, 2-5-1 Shin-Machi, Hirakata City, Osaka, Osaka, JapanTel +81-72-856-2307Fax +81-72-856-2150Email fukumoty@hirakata.kmu.ac.jpPurpose: Ultrasound-based prediction methods for the detection of low muscle mass for sarcopenia in older adults have been explored previously; however, the muscle that most accurately predicts it is unclear. This study aimed to clarify prediction accuracy and cut-off values for ultrasound-derived thigh and lower leg muscle thickness (MT) to detect low skeletal muscle mass index (SMI) in older adults and to estimate cut-off values based on two standard deviations (SD) below younger adult means for the corresponding muscles as an early detection tool for site-specific low muscle mass.Methods: This study included 204 community-dwelling older (64 males, 140 females, mean age: 75.4 years) and 59 younger (31 males, 28 females, mean age: 22.3 years) adults. The MT of the rectus femoris, vastus intermedius, gastrocnemius, and soleus muscles was measured using ultrasound; SMI was measured using bioelectrical impedance analysis.Results: The prevalence of a low SMI among older adults was 20.3% (n=13) for males and 21.4% (n=30) for females. The receiver operating characteristic analysis revealed that the total MT for the four muscles measured presented the highest area under the curve (AUC) value to predict low SMI for males (0.849) and females (0.776). The AUC value was the highest for the total MT of the gastrocnemius and soleus muscles for males and the gastrocnemius for females (0.836, 0.748; cut-off value: 5.67 cm, 1.42 cm, respectively). Muscle-specific differences between the low SMI-predicting and SD-based cut-off values were observed. The SD-based value for the rectus femoris (1.85 cm) was substantially higher than the low SMI-predicting value (1.51 cm) in males.Conclusion: Ultrasound measurement of lower leg muscles may be a simple, robust measure to detect low muscle mass for sarcopenia. Additionally, cut-off values for site-specific muscle mass loss may not always agree with those for whole-limb muscle mass loss.Keywords: area under the curve, bioelectric impedance, skeletal muscle, ultrasound

Keita Suzuki,1 Hiromasa Tsujiguchi,1– 3 Sakae Miyagi,3,4 Thao Thi Thu Nguyen,2 Akinori Hara,1– 3 Haruki Nakamura,2 Yukari Shimizu,5 Koichiro Hayashi,1 Yohei Yamada,1 Phat Minh Nguyen,2 Yuichi Tao,2 Takayuki Kannon,3,6 Atsushi Tajima,3,6 Hiroyuki Nakamura1– 3 1Department of Public Health, Graduate School of Advanced Preventive Medical Sciences, Kanazawa University, Kanazawa, Ishikawa 920-8640, Japan; 2Department of Environmental and Preventive Medicine, Graduate School of Medical Science, Kanazawa University, Kanazawa, Ishikawa 920-8640, Japan; 3Kanazawa University Advanced Preventive Medical Sciences Research Center, Kanazawa, Ishikawa 920-8640, Japan; 4Innovative Clinical Research Center, Kanazawa University, Kanazawa, Ishikawa 920-8640, Japan; 5Department of Nursing, Faculty of Health Sciences, Komatsu University, Komatsu, Ishikawa 923-0961, Japan; 6Department of Bioinformatics and Genomics, Graduate School of Advanced Preventive Medical Sciences, Kanazawa University, Kanazawa, Ishikawa 920-8640, JapanCorrespondence: Keita SuzukiDepartment of Public Health, Graduate School of Advanced Preventive Medical Sciences, Kanazawa University, 13-1, Takara-Machi, Kanazawa, Ishikawa 920-8640, JapanTel +81-76-265-2218Fax +81-76-234-4233Email keitasuzuk@stu.kanazawa-u.ac.jpPurpose: Although the explanation for inconsistencies in the reported association between serum 25-hydroxyvitamin D [25(OH)D] levels and chronic pain (CP) has not yet been determined, understanding this discrepancy is necessary for the development of vitamin D supplementation as an effective treatment for CP. The aim of this cross-sectional study was to examine the relationship between 25(OH)D concentrations and CP according to drinking habits in Japanese subjects.Patients and Methods: We distributed invitation letters to 2314 individuals older than 40 years in Shika town, a rural area in Japan, and 724 subjects (386 females; mean age: 63.9 ± 10.4 years) were recruited. CP was defined as persistent pain lasting at least 3 months in any part of the body. Serum concentrations of 25(OH)D, a biomarker of the vitamin D status, were measured using a radioimmunoassay. A serum 25(OH)D level < 20 ng/mL was defined as serum 25(OH)D deficiency. Drinking habits were assessed using a self-administered questionnaire. There were three choices, “rarely drink”, “sometimes” and “everyday”. Respondents who answered “rarely drink” were labelled as non-drinkers and the others as drinkers.Results: The prevalence of CP was 40.6%. A significant interaction between CP and drinking habits on 25(OH)D concentrations was observed (p = 0.098). A one-way analysis of covariance was performed to compare 25(OH)D concentrations between the subjects with and without CP in each drinking group, and the serum 25(OH)D levels of subjects with CP were significantly lower than those without CP among drinkers (p = 0.007). A logistic regression analysis revealed a correlation between serum 25(OH)D deficiency and CP in drinkers after adjustments for several confounding factors (odds ratio: 0.499; 95% confidence interval: 0.268 − 0.927; p = 0.028).Conclusion: The present results suggest that low serum 25(OH)D concentrations are associated with the development of CP in drinkers.Keywords: pain, vitamin D, alcohol, cross-sectional analysis, epidemiology

Koji Nitta,1 Yutaro Yamada,1 Satomi Morokado,1 Kazuhisa Sugiyama2 1Department of Ophthalmology, Fukui-Ken Saiseikai Hospital, Fukui, Fukui Prefecture, Japan; 2Department of Ophthalmology, Kanazawa University, Kanazawa, Ishikawa Prefecture, JapanCorrespondence: Koji NittaFukui-Ken Saiseikai Hospital, Funabashi 7-1, Wadanaka-Cho, Fukui City, Fukui 918-8503, JapanTel +81 776 23 1111Email nitta.koji7001@fukui.saiseikai.or.jpIntroduction: This study assesses two-year efficacy and safety following implantation of a single trabecular micro-bypass stent (iStent®) with concomitant phacoemulsification cataract surgery in Japanese patients with open-angle glaucoma (OAG).Materials and Methods: This retrospective, consecutive case series included eyes that underwent iStent implantation with phacoemulsification and were followed for 24 months postoperative. Efficacy and safety measures included intraocular pressure (IOP), number of glaucoma medications, adverse events, secondary surgeries, visual fields, and endothelial cell counts.Results: Of 73 operated eyes, 53 eyes had 24 months of follow-up and are analyzed. Diagnoses included primary open-angle glaucoma (POAG, n=25), normal-tension glaucoma (NTG, n=16), and pseudoexfoliative glaucoma (PXG, n=12). At 24 months, mean IOP reduced by 18% to 13.6± 3.0 mmHg versus 16.5± 3.4 mmHg preoperatively (p< 0.0001), and mean medication number reduced by 81% to 0.37± 0.74 versus 1.96± 0.98 preoperatively (p< 0.0001). The percentage of medication-free eyes was 77% versus 0% preoperatively, and 81% of eyes had IOP ≤ 15 mmHg versus 42% preoperatively. Results were similarly favorable across glaucoma subtypes (POAG, NTG, PXG). Notably, mean IOP in NTG eyes decreased to 12.8± 1.4 mmHg from 14.4± 3.0 mmHg preoperatively (p=0.03), and medications decreased by 87% to 0.31± 0.70 versus 2.38± 0.72 preoperatively (p< 0.0001). At 24 months, 81% of NTG eyes were medication-free (versus 0% preoperatively); 2 NTG eyes (13%) were on ≥ 2 medications (versus 100% preoperatively). Throughout the follow-up, visual fields and endothelial cell counts remained stable; 1 eye (1.9%) underwent filtration surgery.Discussion: Favorable safety and significant IOP and mediation reductions were achieved through two years following iStent implantation with phacoemulsification in a Japanese population. These gains were achieved across all glaucoma subtypes (including POAG, NTG, PXG).Conclusion: This real-world study supports the viability of iStent implantation to treat Japanese patients with glaucoma and shows that the benefits extend to those with NTG or PXG in addition to POAG.Keywords: microinvasive glaucoma surgery, MIGS, iStent, trabecular micro-bypass, Japanese, normal-tension glaucoma

Koji Nitta,1,2 Shiro Shimamoto,3 Ryotaro Wajima,2 Gaku Tachibana,2 Yutaro Yamada,1,2 Miyuki Domoto,1 Ryuji Takeda,4,5 Yoshinari Takahashi,6 Kazuhisa Sugiyama2 1Fukui-ken Saiseikai Hospital, Fukui, Japan; 2Department of Ophthalmology, Kanazawa University Graduate School of Medical Science, Kanazawa, Japan; 3Shimamoto Ophthalmology Clinic, Fukui, Japan; 4Department of Nutritional Sciences for Well-Being, Faculty of Health Sciences for Welfare, Kansai University of Welfare Sciences, Osaka, Japan; 5Department of Applied Biological Chemistry, Faculty of Agriculture, Kindai University, Nara, Japan; 6Inary Co., Ltd., Tokyo, JapanCorrespondence: Koji NittaDepartment of Ophthalmology, Fukui-ken Saiseikai Hospital, 7-1 Funabashi, Wadanaka-cho, Fukui 918-8503, JapanTel +81 776 23 1111Fax +81 776 28 8515Email nitta.koji7001@fukui.saiseikai.or.jpBackground: This retrospective study evaluated the effect of adjunctive administration of brimonidine 0.1% on disc hemorrhage (DH) in patients with primary open-angle glaucoma or normal-tension glaucoma who were already treated with other anti-glaucoma drugs.Methods: Patients with DH, before adjunctive therapy with brimonidine, were enrolled. Subjects were excluded if their treatment regimen was changed within 1 year after initiation of adjunctive therapy with brimonidine. We investigated the frequency of DH and intraocular pressure (IOP). Both parameters were compared before and after adjunctive administration of brimonidine.Results: The frequency of DH before and after brimonidine administration was 0.67± 0.68 and 0.31± 0.72 times/year, respectively, with a significant decrease (P=0.01), and the mean IOP before and after brimonidine administration was 12.5± 1.9 and 11.2± 2.2 mmHg, respectively, (P=0.0006) with a significant reduction after adjunctive administration.Conclusion: The results of this study supported the hypothesis that the frequency of DH is reduced by brimonidine alongside lowering of IOP.Keywords: disc hemorrhage, intraocular pressure, brimonidine, primary open-angle glaucoma, normal-tension glaucoma

Koji Takeda,1,2 Norio Sugawara,3 Yuji Yamada,1 Takako Nagata,1 Hiroko Kashiwagi,1 Toshiaki Kono,4 Naotsugu Hirabayashi,1 Takayuki Okada2 1Department of Psychiatry, National Center of Neurology and Psychiatry Hospital, Kodaira, Tokyo 187-8551, Japan; 2Section of Psychiatry and Behavioral Sciences, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo 113-8510, Japan; 3Department of Psychiatry, Dokkyo Medical University School of Medicine, Tochigi 321-0843, Japan; 4Department of Community Mental Health and Law, National Institute of Mental Health, National Center of Neurology and Psychiatry, Kodaira, Tokyo 187-8553, JapanCorrespondence: Koji TakedaDepartment of Psychiatry, National Center of Neurology and Psychiatry Hospital, 4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8551, JapanTel +81 42 341 2711Fax +81 42 344 6745Email ideakojijan@ncnp.go.jpPurpose: Employment is important for forensic psychiatric patients with psychotic disorders, in terms of reduction in symptoms, improving the quality of life, and preventing re-offenses. However, few detailed studies on employment status in such patients exist. We aimed to determine the employment rate among forensic psychiatric outpatients with psychotic disorders and identify the factors associated with employment.Patients and methods: The study population comprised 406 patients with psychotic disorders who completed a forensic outpatient treatment order, were aged discharge from a forensic psychiatric ward and provided written informed consent. Psychotic disorders were defined as psychiatric disorders classified into F2 in the International Statistical Classification of Diseases and Related Health Problems, 10th edition. Demographic data were collected from the medical records of the inpatient treatment period. Prognostic data during the outpatient treatment order period was provided by the reintegration coordinators responsible for coordinating the patients’ social environment during this period. Exploratory univariate and multivariable logistic regression analyses identified the factors associated with employment. Results: The mean age at discharge was 44.4±10.8 years. The mean follow-up period was 2.69±1.01 years. There were 4.6 times more men (n=334) than women (n=72). During the outpatient treatment order period, 56 of 406 participants achieved employment (13.8%). Participants who committed serious crime, including homicide, arson, robbery, and sexual assault, had a lower employment rate compared to participants who committed bodily injury crimes (multivariable odds ratio, 0.421; 95% confidence interval, 0.220–0.807). History of substance use and living with family after discharge from a forensic psychiatric ward positively contributed to employment. Conclusion: The employment rate among forensic psychiatric outpatients with psychotic disorders was low and was similar to that reported in previous studies on general psychiatric patients with schizophrenia. Furthermore, serious criminal behavior negatively impacted employment.Keywords: criminal behavior, schizophrenia, work, job, mentally disordered offenders

We aimed to determine the usefulness of release push test (RPT) in detecting shoulder pain in baseball players with throwing shoulder injury. Fifty-five baseball players with throwing shoulder injury were recruited. RPT entailed pushing the examiner's hand while simulating the hand position of releasing the ball during throwing. Full can, empty can test, hyper-external rotation test (HERT), Neer impingement sign, Hawkins impingement sign, and O'Brien test were also performed. All tests were considered positive if shoulder pain was provoked during the test. The RPT positivity rate was 51%, which was the highest among all the tests. Ten patients had only RPT positive during the examination; it had the highest single positivity which was also seen with HERT. The players with RPT positivity reported significantly more shoulder pain after the cocking phase of throwing compared to players with HERT positivity who reported more shoulder pain in the cocking phase. This study suggested that RPT may be a useful pain provocation test to assess the start or change in strength of throwing because it showed high positivity rate and could detect specific pain in players with throwing shoulder injury. [ABSTRACT FROM AUTHOR]

Yuya Watanabe,1–3 Masahiro Ikenaga,4 Eiichi Yoshimura,5 Yosuke Yamada,2,6 Misaka Kimura2,3 1Faculty of Health and Sports Science, Doshisha University, Kyotanabe, Japan; 2Laboratory of Applied Health Sciences, Kyoto Prefectural University of Medicine, Kyoto, Japan; 3Department of Health and Sports, Faculty of Health and Medical Sciences, Kyoto Gakuen University, Kameoka, Japan; 4Central Research Institute for Physical Activity, Fukuoka University, Fukuoka, Japan; 5Department of Food and Health Sciences, Prefectural University of Kumamoto, Kumamoto, Japan; 6Laboratory of Healthy Longevity Research, National Institute of Health and Nutrition, National Institutes of Biomedical Innovation, Health and Nutrition, Tokyo, Japan Background: Skeletal muscle experiences both quantitative and qualitative changes with aging. Echo intensity (EI) of the skeletal muscle obtained by ultrasonography (US) has been considered to reflect muscle quality. This technique is noninvasive, easily accessible, and is relatively inexpensive than that of other imaging techniques such as computed tomography (CT). Previous studies have reported that EI is related to several physical performances. However, few studies have investigated the validity of EI against other imaging methods in case of imaging of the skeletal muscle. We compared quantitative and qualitative indices evaluated by the US and CT imaging systems to strengthen their validity.Participants and methods: A total of 40 adults participated in this study: 19 young (10 men and 9 women; their mean (±SD) age was 22.7±1.5 years) and 21 older adults (13 men and 8 women; their mean age was 70.6±4.8 years). Both thighs of each participant were evaluated using US and CT imaging systems.Results: With respect to the US indices, the young group had significantly higher muscle thickness (MT) of the front thigh (P

Yuya Watanabe,1–4,* Yosuke Yamada,2,4,* Keiichi Yokoyama,2,5,6,* Tsukasa Yoshida,2,4,7 Yasuko Yoshinaka,5,6 Mie Yoshimoto,8 Yoko Tanaka,9 Aya Itoi,10 Emi Yamagata,11 Naoyuki Ebine,1 Kazuko Ishikawa-Takata,12 Misaka Kimura2,3 1Faculty of Health and Sports Science, Doshisha University, Kyotanabe, Japan; 2Laboratory of Applied Health Sciences, Kyoto Prefectural University of Medicine, Kyoto, Japan; 3Department of Health and Sports Sciences, Kyoto Gakuen University, Kameoka, Japan; 4Section of Healthy Longevity Research, National Institute of Health and Nutrition, National Institutes of Biomedical Innovation, Health and Nutrition, Tokyo, Japan; 5Specified Non-profit Corporation Genki-up AGE Project, Kameoka, Japan; 6Department of Business Administration, Kyoto Gakuen University, Kyoto, Japan; 7Senior Citizen’s Welfare Section, Kameoka City Government, Kameoka, Japan; 8Corporation of Japan Dental Hygienists’ Association, Kyoto, Japan; 9Kyoto Dietetic Association, Kyoto, Japan; 10Department of Health, Sports and Nutrition, Faculty of Health and Welfare, Kobe Women’s University, Kobe, Japan; 11Faculty of Nursing, Doshisha Women’s College of Liberal Arts, Kyotanabe, Japan; 12Department of Nutrition and Metabolism, National Institute of Health and Nutrition, National Institutes of Biomedical Innovation, Health and Nutrition, Tokyo, Japan *These authors contributed equally to this work Objective: The number of long-term care (LTC) users and the associated expenditures in Japan are increasing dramatically. The national government recommends LTC prevention through activation of communities. However, there is no clear evidence of the effect of population-based comprehensive geriatric intervention program (CGIP) for restraints of LTC users and the associated expenditures in the future. The aims of the current paper are to describe the study protocol and progress of a cluster randomized controlled trial (RCT) with a CGIP in Kameoka City. Methods: The cluster RCT involved random allocation of regions as intervention (n=4,859) and nonintervention (n=7,195). Participants were elderly persons aged ≥65 years without LTC certification who had responded to a mailing survey. The residents living in intervention regions were invited to a physical check-up, and 1,463 people participated (30.3%). These individuals were invited to the CGIP, and 526 accepted. The CGIP comprised instructions on: 1) low-load resistance training using bodyweight, ankle weights, and elastic bands; 2) increasing daily physical activity; 3) oral motor exercise and care; and 4) a well-balanced diet based on a program from Ministry of Health, Labour and Welfare. We allocated the intervention regions randomly into home-based self-care program alone (HB group, 5 regions, n=275) and home-based program+weekly class-style session (CS group, 5 regions, n=251). We evaluated the effects of the CGIP at 12 weeks and at 12 or 15 months on physical function, and are conducting follow-up data collection for an indefinite period regarding LTC certification, medical costs, and mortality. Results and discussion: The study was launched with good response rates in each phase. Participants of both groups significantly increased their step counts by ~1,000 per day from the baseline during the CGIP. This RCT will provide valuable information and evidence about effectiveness of a community-based CGIP. Keywords: frailty, sarcopenia, long-term care, ActiveGuide, low-load resistance training, oral care, nutritional intervention, Shokuiku, physical function, physical activity monitor