Probable Respiratory Sarcopenia Decreases Activities of Daily Living in Older Patients Hospitalized with Respiratory Diseases: A Cross-sectional Study.

Objectives: Respiratory sarcopenia is characterized by low respiratory muscle mass and respiratory muscle strength, but its impact on activities of daily living (ADL) remains unknown. We aimed to investigate the association between respiratory sarcopenia and decreased ADL. Methods: This retrospective cross-sectional study included older inpatients (≥65 years old) with respiratory diseases who underwent rehabilitation. Because the evaluation of respiratory muscle mass is challenging, probable respiratory sarcopenia was defined according to low appendicular skeletal muscle index (<7 kg/m2 for men, <5.7 kg/m2 for women) and peak expiratory flow rate (<4.4 L/s for men, <3.21 L/s for women). ADL was assessed on the first day of rehabilitation using the baseline Barthel Index (BI). Results: Of 111 inpatients (median age 75 years; 57 women), 13 (11.7%) had probable respiratory sarcopenia. Forty-five patients (40.5%) had sarcopenia and 12 of these had probable respiratory sarcopenia. Pulmonary functions (Forced Vital Capacity and expiratory volume in 1 s) were significantly lower in patients with probable respiratory sarcopenia than those without. Spearman's rank coefficient analysis showed probable respiratory sarcopenia did not significantly correlate with age, phase angle, Charlson Comorbidity Index (CCI), or hemoglobin (Hb). Multivariate linear regression analysis with baseline BI revealed probable respiratory sarcopenia (ß -0.279 and P=0.004) was the significant factor after adjusting for age, sex, body mass index, chronic obstructive pulmonary disease, CCI, and Hb. Conclusions: Probable respiratory sarcopenia was independently associated with decreased ADL in patients aged 65 years and older who were hospitalized with respiratory diseases.

Impact of Presarcopenic Dysphagia on 1-Year Mortality After Videofluoroscopic Swallowing Study in Patients with Cancer.

Sarcopenic dysphagia is the term for swallowing difficulty associated with loss of mass, strength, and physical performance, which leads to increased pharyngeal residues. Unlike sarcopenia, presarcopenia is characterized by low muscle mass without decreased muscle strength or physical performance and can develop into dysphagia due to low skeletal muscle mass. This retrospective study investigated the impact of presarcopenic dysphagia (PSD) on 1-year mortality in patients with cancer and dysphagia who underwent a videofluoroscopic swallowing study (VFSS). An operational definition of PSD based on presarcopenia and pharyngeal residues was adopted. The psoas muscle mass index (cm2/height [m2]), calculated by the psoas muscle area at the third lumber vertebra via abdominal computed tomography (CT) and related to height, was used to assess presarcopenia with cutoff values of 4.62 for men and 2.66 for women. Pharyngeal residues were assessed using a VFSS to evaluate dysphagia. Patients' medical charts were analyzed to investigate 1-year mortality after a VFSS. Out of 111 consecutive patients with cancer, 53 (47.7%) were defined as having PSD. In a forward-stepwise Cox proportional regression analysis, PSD (HR 2.599; 95% CI 1.158-5.834; p = 0.021) was significantly associated with 1-year mortality after a VFSS, even after adjusting for the factors of operation, Functional Oral Intake Scale (FOIS) scores at discharge, and modified Barthel Index (BI) scores at discharge. PSD, defined as CT-based presarcopenia and pharyngeal residues observed during a VFSS, is associated with increased 1-year mortality in patients with cancer and dysphagia.

Survey of patients with stroke in the Kitakyushu Area, Japan: a 12-year retrospective analysis of the critical pathway.

OBJECTIVES: We aimed to clarify the incidence, clinical profile, outcome, and activities of daily living of patients with stroke using the Kitakyushu clinical pathway database and to investigate the characteristics of patients with stroke in the Kitakyushu medical area in Japan. MATERIALS AND METHODS: The clinical data of patients with stroke registered in the Kitakyushu database between April 1, 2009 and December 31, 2021 were retrospectively examined. The National Institutes of Health Stroke Scale was used to classify stroke severity. A descriptive analysis of basic variables, including age, stroke type, length of hospital stay, and activities of daily living, according to stroke severity was conducted. RESULTS: There were 7,487 acute care hospital patients and 5,441 rehabilitation hospital patients. Compared with patients in similar cities in Japan, patients in the Kitakyushu area tended to be older at the time of stroke onset with a higher proportion of cases of hemorrhagic stroke. Length of hospital stay in both acute and rehabilitation hospitals increased with stroke severity. The Functional Independence Measure gain was highest in patients with moderate disability. CONCLUSIONS: Compared with patients in similar cities in Japan, in the Kitakyushu area, patients with stroke were older and the proportion of patients with hemorrhagic stroke was higher. Stroke rehabilitation therapy is effective for patients with moderately severe stroke.

The Relationship Between Preoperative Frailty Risk as Assessed by the Hospital Frailty Risk Score and the Outcome at Discharge in Coronary Artery Bypass Grafting (CABG) Patients: A Retrospective Observational Study Using the Diagnosis Procedure Combination Database.

The relationship between the Hospital Frailty Risk Score (HFRS)-based frailty risk and outcomes after coronary artery bypass grafting (CABG) is yet unclear. The objective of this study was to investigate the relationship between preoperative frailty risk as assessed by the HFRS and postoperative outcomes in patients undergoing CABG. This observational study used the diagnosis procedure combination (DPC) system in Japan (2014-2017). In total, 35,015 adults aged ≥ 65 years and diagnosed with angina pectoris and acute myocardial infarction who had undergone CABG were enrolled. We investigated the association between the HFRS-based frailty risk and the home discharge rate, as well as the prevalence of complications. Multilevel logistic regression analysis revealed that having an HFRS ≥ 5 was a determinant of lower home discharge rate (odds ratio [OR] 0.60, 95% confidence interval [CI] 0.49-0.74, P <0.01), aspiration pneumonia (OR 2.25, 95%CI 1.27-3.96, P <0.01) and disuse syndrome (OR 1.90, 95%CI 1.23-2.94, P <0.01). Preoperative stratification of frailty risk using HFRS may help in predicting postoperative progress and in planning postoperative rehabilitation.

Association of Preoperative Rehabilitation With Postoperative Length of Hospital Stay for Elderly Lung Cancer Patients.

This study aimed to evaluate the effect of preoperative rehabilitation on postoperative hospital stay in elderly lung cancer patients following lung resection. This was a retrospective observational study using the Japanese Diagnosis Procedure Combination database. Data of patients diagnosed between April 2016 and March 2020 were collected. Patients were identified using the International Statistical Classification of Disease and Related Health Problems Version 10-10 codes, C34.0-C34.3 and C34.8. Multilevel linear regression analysis was performed to evaluate the effect of preoperative rehabilitation on the length of hospital stay. A total of 9,393 patients were included in the study. Univariate analysis showed that preoperative rehabilitation was significantly associated with postoperative length of hospital stay (coefficient: -1.61; 95% confidence interval: -2.42, -0.81; P <0.001). In addition, multivariate analysis showed preoperative rehabilitation to be associated with a significant decrease in postoperative length of hospital stay (coefficient=-1.38; 95% confidence interval: -2.19, -0.58; P =0.001). Preoperative rehabilitation may shorten length of hospital stay in elderly patients with lung cancer.

Rate of return to work in patients with stroke under the health and employment support program of Rosai hospitals in Japan.

To facilitate return to work (RTW) in patients with stroke, a health and employment support (HES) program was started at Rosai hospitals in Japan. This study aimed to determine the rate of RTW in patients with stroke under this support program. We collected demographic and clinical data of patients with stroke from the implementation reports of the HES program. The program provided coordinated dual support, such as acute medical treatments, and stroke and vocational rehabilitation on the medical side, and management and support on the workplace side. The primary endpoint was RTW. Successful and unsuccessful RTW were examined using the χ2 test. The RTW rate curves were analyzed using the Kaplan-Meier method. We enrolled 483 patients; 355 (73%) and 128 (27%) patients had successful and unsuccessful RTW, respectively. Stroke types, neurological findings, and activities of daily living were significant factors for RTW. The Kaplan-Meier method revealed that left hemiplegia, right hemiplegia, and neuropsychological deficits, except for combined disability (hemiplegia with neuropsychological deficits), had similar RTW curves with an RTW rate of > 70%.

Frailty and occupational falls among older Japanese workers: An Internet-based cross-sectional study.

OBJECTIVES: Occupational falls are a major problem for older workers, especially those in the tertiary industry. Recently, it has been suggested that frailty is associated with occupational falls, but it is unclear whether this holds true for older workers in the tertiary industry. This study examined the relationship between frailty and occupational falls among older workers in the tertiary industry. METHODS: This was an Internet-based cross-sectional study. We recruited 5000 older workers (age, 60-75 years) employed in the tertiary industry who were registered with an Internet research company. Frailty was assessed using the Frailty Screening Index's five items, and participants were classified into robust, pre-frailty, or frailty groups. Occupational falls were defined as falls experienced in the past 12 months while at work. The relationship between frailty and occupational falls was analyzed by logistic regression analysis. RESULTS: It was found that 6.1% of participants had experienced at least one occupational fall in the past 12 months. On the multivariate analysis, the adjusted odds ratio (aOR) for falls was higher with pre-frailty (aOR: 1.95, 95% confidence interval: 1.30-2.94, P = .001) and frailty (aOR: 4.26, 95% confidence interval: 2.74-6.65, P < .001) compared with robust. Similar results were obtained when the outcome was occupational falls with injury. CONCLUSION: Our findings suggest that frailty is associated with occupational falls among older workers in tertiary industries. We recommend that employers introduce frailty screening, and consider countermeasures based on the screening results to prevent occupational falls among older workers.

Effect of Early Postoperative Rehabilitation on Length of Hospital Stay after Robot-assisted Radical Prostatectomy.

Objectives: : This study assessed how early postoperative rehabilitation interventions affected the duration of hospital stay in patients with prostate cancer who had radical prostatectomy with robotic assistance. Methods: : From the Japanese Diagnosis Procedure Combination database, we extracted case data for patients discharged between April 2014 and March 2020. Patients were recognized by code C61 from the International Classification of Diseases, 10th Edition. We ran a multilevel linear regression analysis to investigate the impact of early rehabilitation on the duration of hospital stay. Results: : There were 2151 participants in the trial. In patients with prostate cancer who had resection utilizing robotic-assisted devices, early rehabilitation was related to a substantial decrease in duration of hospital stay (coefficient, -0.86; 95% CI, -1.64 to -0.07; P=0.032). Conclusions: : Early postoperative rehabilitation may contribute to shorter hospital stays in patients with prostate cancer at high risk of both postoperative complications and a decline in their ability to perform activities of daily living.

Negative impact of computed tomography-based low skeletal muscle mass on swallowing recovery in patients with post-stroke dysphagia.

OBJECTIVES: Dysphagia due to stroke has a high prevalence, and evaluating the swallowing function of dysphagia and promoting oral intake is essential in patients with stroke. The psoas muscle mass index（cm2/height2（m2））, calculated by the psoas muscle area at the L3 level via abdominal computed tomography （CT）, can predict the development of dysphagia. However, knowledge about the impact of CT-based skeletal muscle mass on swallowing recovery, remains unknown. Therefore, we investigated whether CT-based low skeletal muscle mass impacted swallowing recovery. METHODS: A retrospective cohort study was conducted on patients with post-stroke dysphagia who underwent acute treatments along with a videofluoroscopic swallowing study（VFSS）. Swallowing recovery was identified as the improvement of the Functional Oral Intake Scale （FOIS） from the time of VFSS to discharge（observational period: ObPd）. The psoas muscle mass index's cut-off values for low skeletal muscle mass were 3.74 cm2/m2 and 2.29 cm2/m2 for men and women respectively. RESULTS: There were 53 subjects （36 male, median age 73.9）. The median during the ObPd was 26 days, and the median days from onset to admission and admission to VFSS were 0 and 18, respectively. Sixteen patients had low skeletal muscle mass. The median improvement of FOIS during the ObPd was 2, and the median length of hospital stay was 51 days. In the stepwise multiple linear regression analysis for the improvement of FOIS during the ObPd, low skeletal muscle mass （ߠ- 0.245; 95% confidence interval - 2.248 to - 0.127; p = 0.029） was a significant factor, even adjusted for serum albumin at admission, disturbance of consciousness at VFSS, FOIS at VFSS, and aspiration during VFSS. CONCLUSION: CT-based low skeletal muscle mass negatively impacted swallowing recovery during the ObPd in patients with post-stroke dysphagia.

Preoperative decline in skeletal muscle strength of patients with cardiovascular disease affects postoperative pulmonary complication occurrence: a single-center retrospective study.

BACKGROUND: Dynapenia, defined as age-related skeletal muscle strength decline, has been reported as a poor prognostic factor in patients with cardiovascular disease. Decline in skeletal muscle strength (DS), the main symptom of dynapenia, may be an important clinical indicator in patients undergoing cardiac surgery. However, the relationship between DS and postoperative pulmonary complication occurrence is unclear. Herein, we investigated the relationship between preoperative DS and postoperative pulmonary complication occurrence in patients undergoing cardiac surgery. METHODS: We enrolled 125 patients who underwent cardiac surgery. DS was determined by low grip strength and quadriceps isometric strength. The patients were divided into DS and non-DS groups. The relationship between the clinical characteristics and preoperative physical function was compared, and factors associated with postoperative pulmonary complication occurrence were investigated using multivariate logistic regression analysis. RESULTS: There were 42 (33.6%) patients in the DS group and 83 (66.4%) patients in the non-DS group. Compared with the non-DS group, the DS group was significantly older and had a higher body mass index and Japan SCORE (operative mortality rate and major complication rate). The DS group also had a lower estimated glomerular filtration rate and preoperative Barthel index than the non-DS group. Furthermore the DS group had a significantly higher incidence of postoperative pulmonary complications and length of intensive care unit stay, and their postoperative rehabilitation was prolonged compared to the non-DS group. Multivariate logistic regression analysis revealed that DS was a determinant of postoperative pulmonary complications (odds ratio 4.26, 95% confidence interval 1.63‒11.14). CONCLUSIONS: We showed that preoperative DS was an independent risk factor for postoperative pulmonary complications in patients undergoing cardiac surgery. Skeletal muscle strength before cardiac surgery may be an important clinical indicator for predicting the prognosis of patients from post-surgery to discharge and for planning postoperative rehabilitation programs.

Pre-operative Physical Performance Is Associated With Early Return to Work in Peri-operative Lung Cancer Patients.

Little is known about the factors related to return to work (RTW) in patients with peri-operative lung cancer (LC). This study aimed to investigate whether pre-operative physical performance is associated with early RTW in patients with peri-operative LC. A total of 59 patients who wished to resume work after lung resection surgery were included and were divided into three groups: early RTW (within 14 days after discharge), delayed RTW (within 15-90 days), and non-RTW (failure of RTW within 90 days). The early RTW group had significantly lower scores on the modified Medical Research Council dyspnea scale (mMRC) and significantly higher scores on the Euro Quality of Life 5-Dimension 3-Level (EQ-5D-3L) than the non-RTW group. Multivariate logistic regression analysis showed that EQ-5D-3L scores were significantly associated with early RTW, and mMRC scores and knee extensor strength tended to be associated with early RTW. Better pre-operative quality of life, mild dyspnea, and greater lower limb muscle strength tended to be associated with early RTW in patients with peri-operative LC.

A survey of the implementation rate of cardiac rehabilitation for patients with heart disease undergoing device implantation in Japan.

Background: The effect of cardiac rehabilitation (CR) on patients undergoing device implantation (DI) for arrhythmias has been reported; however, the implementation status of these patients has not been clarified. This study aimed to verify the implementation status of CR for patients with heart disease who have undergone DI using real-world data. Methods: This was an observational study using a nationwide administrative database associated with the diagnosis procedure combination (DPC) system in Japan (2014-2018). Subjects were patients with heart disease (70 667 cases) who underwent DI during the above scheduled hospitalization period. The overall rate of CR and the background factors of the subjects were verified. Results: The CR rate for patients with heart disease who underwent DI during hospitalization was 23%, and the CR rate for patients with comorbid heart failure who underwent DI was only 32%. It was confirmed that progressing age was associated with a higher CR implementation rate. The lower the Barthel index score at the time of admission, the higher the CR implementation rate. Conclusions: CR was performed for only one-quarter of all the patients during admission for DI and just one-third of the patients for DI with heart failure. Most of these patients were elderly and had a decreased ability to perform activities of daily living. The DPC data are subject to various limitations, and further research is necessary.

Qualitative study of barriers and facilitators encountered by individuals with physical diseases in returning and continuing to work.

BACKGROUND: The number of employees with physical diseases is increasing, and there is a need for support to help them return and continue to work. To provide effective support, it is important to identify barriers and facilitators for individuals in returning and continuing to work. Previous studies have reported barriers and facilitators for specific diseases. However, few reports have dealt with these issues across various diseases. To identify a range of barriers and facilitators that may apply to different physical diseases, we conducted a qualitative analysis by interviewing patients with diverse characteristics being treated for diseases. METHODS: We conducted semi-structured interviews based on the criteria for qualitative research. We investigated three disease groups to obtain details of barriers and facilitators: impairments that were visible to other people (mainly stroke); impairments invisible to others (mainly heart disease); and impairments that changed over time (mainly cancer). Interview transcripts were analyzed and the results reported using systematic text condensation. RESULTS: We extracted 769 meaning units from 28 patient interviews. We categorized barriers and facilitators that were generalizable to various diseases into three themes (personal factors, workplace factors, and inter-sectoral collaboration and social resources) and 10 sub-themes (work ability, psychological impacts, health literacy, social status, family background, workplace structure, workplace system, workplace support, inter-sectoral collaboration, and social resources). CONCLUSIONS: This study identified 10 sub-themes that can be applied for workers with physical diseases; those sub-themes may be used as a basis for communicating with those individuals about returning and continuing to work. Our results suggest that various barriers and facilitators for workers with physical diseases should be understood and addressed at medical institutions, workplaces, and support sites.

Effect of online physical therapy on workplace accident-related outcomes in nursing care worker: study protocol of a multicentre randomised controlled trial.

INTRODUCTION: According to the 2017 data, occupational accidents are more common in social welfare facilities compared with other industries; in particular, the number of occupational accidents resulting in four or more days of absence from work due to low back pain (LBP) or falls has increased and is considered problematic. Although physical therapy has been demonstrated to be effective in preventing LBP and falls in older adults living in the community, no randomised controlled trials have examined whether individual online physical therapy can prevent LBP and falls in nursing care workers (NCW). METHODS AND ANALYSIS: A total of 120 NCW aged 20 years or older will be randomly assigned to an online individualised therapy group (ITG) or usual group (UG) after obtaining informed consent. We defined an NCW as a person who assists disabled and elderly persons with eating, bathing and toileting activities in social welfare facilities. We will follow-up the participants 12 months after the start of the intervention and compare the results at 3, 6 and 12 months. The primary endpoint will be the Oswestry Disability Index (ODI); ITG participants will receive professional advice on LBP and musculoskeletal problems from a physical therapist via online interview and email as often as they wish over a 6-month period; UG participants will only have access to brochures and video feeds related to LBP and fall prevention. Owing to the nature of the study, blinding the participants and interventionists is not possible; however, the outcomes will be assessed via a web-based questionnaire to prevent detection bias. The null hypothesis is that there is no clinically important difference in the primary outcome between the two treatment groups and that a decrease in the ODI score of at least 20% is clinically meaningful. ETHICS AND DISSEMINATION: The Ethics Committee of the Japanese Society of Occupational Medicine approved the protocol of this study. The results of this study will be disseminated through peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: jRCT1070210128.

[Use of a Guidebook for Stroke Patients to Promote Health and Employment Support].

When stroke patients consider a return to work, several difficulties are encountered regarding the promotion of support for both their health and employment due to the different perspectives of the patients, their families, and medical institutions. The Japanese Ministry of Health, Labour and Welfare has published a guideline for medical institutions and offices, but not for stroke patients or their families. As a result, patients and their families do not know how to process both medical treatments and their work after the occurrence of a stroke. We have therefore published the "Guidebook for Stroke Patients to Promote Health and Employment Support" based on the concept of the previously published "Guidebook for Cancer Patients for Promoting Health and Employment Support". This publication offers an overview of stroke and the flow from stroke onset to return to work. Patients can confirm how they should be handled at different phases of stroke. A stroke affects the patient, their family, and the individuals providing support, so this publication offers an information tool to facilitate the participation of stroke patients in society. The guide can thus be expected to contribute to an increased rate of return to work by stroke patients.

Excessive Workload Beyond Measured Exercise Tolerance Affects Post-Discharge Mental Health in Workers With Heart Disease: A Case-Based Observational Study.

OBJECTIVE: We evaluated work intensity, exercise tolerance, and mental health among workers with heart disease and assessed the relationship between return to work (RTW) status and changes in mental health 3 months post-discharge. METHODS: Patients were enrolled from 2014 to 2019. Data were collected on admission and 3 months post-discharge. Mental health was assessed using the Hospital Anxiety and Depression Scale. Jobs were defined as "reasonable workload (RW)" or "over workload (OW)" based on metabolic equivalents. RESULTS: Twenty-six patients responded (81.3%). RTW after 3 months was higher in the RW group (100%) than in the OW group (63.6%). Mental health in the OW group significantly deteriorated compared with baseline and was higher than that in the RW group. CONCLUSIONS: Patients whose work intensity was higher than their exercise tolerance had worsened mental health 3 months post-discharge.

Pre-transplant Rehabilitation to Decrease the Post-transplant Length of Stay for Hematological Malignancy Patients Undergoing Allo-HSCT.

OBJECTIVES: Pre-transplant rehabilitation for hematological malignancy patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) helps improve physical capacity. However, its benefit with respect to post-transplant hospital length of stay (LOS) is unclear. Consequently, the aim of this study was to investigate the effect of pre-transplant rehabilitation on post-transplant LOS for hematological malignancy patients undergoing allo-HSCT. METHODS: Data on patients diagnosed between April 2014 and March 2017 were collected from the Japanese Diagnosis Procedure Combination database. The patients were identified using the ICD-10 codes C81-85, C90-94, C96, and D46. Multilevel linear regression analyses were conducted to identify the effects of pre-transplant rehabilitation on post-transplant LOS (log transformed). RESULTS: In total, 3614 patients were included in the study. Pre-transplant rehabilitation was associated with a significant reduction in post-transplant hospital LOS (ß=-0.134, P<0.001). CONCLUSIONS: Pre-transplant rehabilitation may be an effective strategy for shortening the post-transplant hospital LOS in hematological malignancy patients undergoing allo-HSCT. Consequently, it may be necessary to consider starting rehabilitation before transplantation.

Clinical effectiveness of peroneal nerve functional electrical stimulation in chronic stroke patients with hemiplegia (PLEASURE): A multicentre, prospective, randomised controlled trial.

OBJECTIVE: To compare the effectiveness of gait training using a peroneal nerve stimulation device with the effectiveness of gait training without the device in improving gait ability and ankle-specific body functions. DESIGN: Multicentre, prospective, randomised, open-label trial. SETTING: Twenty-three hospitals. SUBJECTS: In total, 119 stroke patients with foot drop were randomly assigned to the experimental (with the device) or control (without the device) group. INTERVENTION: Subjects underwent 480-minute self-directed training over four weeks, followed by 260-minute physical therapist-assisted gait training with or without the device. MAIN MEASURES: The primary endpoint was a change in the six-minute walk test (6MWT) without the device from baseline to after the four-week intervention. The secondary endpoints were changes in the 10-metre walk test (10MWT) without the device, Fugl-Meyer Assessment, range of motion, muscle strength, Modified Ashworth Scale, Stroke Impact Scale Japanese edition (J-SIS) and adverse events. RESULTS: Fifty-six experimental and 59 control group participants, with an average age of 59 years (SD 12) completed the trial. The 6MWT distance changes (m) for the experimental and control groups were 14.7 (SD 37.6) and 22.2 (SD 49.3), respectively. The 10MWT speed changes (m/sec) for the experimental and control groups were 0.06 (SD 0.12) and 0.07 (SD 0.17), respectively. No significant differences were observed in these changes between both groups, and no differences were found in the other secondary endpoints, except for the J-SIS patient's subjective assessment (P = 0.048). CONCLUSION: The improvement in gait ability and body functions were equivalent with or without the use of the device.

Efficacy and safety of incobotulinumtoxinA in post-stroke upper-limb spasticity in Japanese subjects: results from a randomized, double-blind, placebo-controlled study (J-PURE).

BACKGROUND: Upper-limb spasticity frequently occurs after stroke and there is a clinical need for more effective therapies. The Phase III J-PURE study assessed the efficacy and safety of incobotulinumtoxinA up to 400 U for post-stroke upper-limb spasticity in Japan. METHODS: In the 12-week main period (MP) of this double-blind, placebo-controlled study, Japanese subjects with upper-limb spasticity received one injection cycle of incobotulinumtoxinA 400 U, 250 U, or matching placebo. Eligible subjects enrolled in an open-label extension (OLEX) period of three injection cycles of incobotulinumtoxinA 400 U (32-40 weeks). The primary objective was to establish the efficacy of a single incobotulinumtoxinA injection using the Modified Ashworth Scale (MAS) wrist score. Secondary efficacy outcomes and safety were also assessed. RESULTS: Among 100 treated subjects, AUCs for incobotulinumtoxinA 400 and 250 U were significantly different versus placebo (p = 0.0014 and p = 0.0031, respectively) for change from baseline in MAS wrist score to the end of the MP, with similar results from baseline to week 4. IncobotulinumtoxinA 400 U was superior versus placebo across other spasticity patterns and at most study visits. Improvements were maintained throughout the OLEX period. Disability Assessment Scale and Investigator's Clinical Global Impression scores improved significantly for incobotulinumtoxinA 400 U versus placebo from baseline to week 4 (p = 0.0067 and p < 0.0001, respectively). IncobotulinumtoxinA was well tolerated up to 52 weeks, with no unexpected adverse events. CONCLUSION: IncobotulinumtoxinA reduced (pathologically) increased muscle tone, improved functionality and was well tolerated in Japanese subjects with post-stroke upper-limb spasticity.

Effects of a Physical Therapist Led Workplace Personal-Fitness Management Program for Manufacturing Industry Workers: A Randomized Controlled Trial.

OBJECTIVE: Workplace fitness programs are used to improve worker physical capacity. We aimed to evaluate the effectiveness of physical therapist (PT) led personal-fitness management programs (PP) on manufacturing worker physical performance assessed using a 30-second chair stand (CS-30) test. METHODS: This assessor-blinded, randomized controlled trial enrolled 60 manufacturing workers allocated to a workplace PP group (PPG) or control group (CG). The PPG received monthly, PT managed, individualized PP for 6 months. The CG received a 90-minute group-fitness management course once during the study period. RESULTS: CS-30 significantly improved in both groups (PPG and CG, P < 0.001) following the intervention. There were significant group-time interaction effects, and the PPG experienced a significantly greater improvement in CS-30 results compared with CG (P < 0.001). CONCLUSIONS: Individualized PT-led workplace PP may be more effective in improving worker physical performance.