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    Fatal and Nonfatal Events Within 14 days After Early, Intensive Mobilization Poststroke
    Bernhardt, J ; Borschmann, K ; Collier, JM ; Thrift, AG ; Langhorne, P ; Middleton, S ; Lindley, RI ; Dewey, HM ; Bath, P ; Said, CM ; Churilov, L ; Ellery, F ; Bladin, C ; Reid, CM ; Frayne, JH ; Srikanth, V ; Read, SJ ; Donnan, GA (LIPPINCOTT WILLIAMS & WILKINS, 2021-02-23)
    OBJECTIVE: This tertiary analysis from A Very Early Rehabilitation Trial (AVERT) examined fatal and nonfatal serious adverse events (SAEs) at 14 days. METHOD: AVERT was a prospective, parallel group, assessor blinded, randomized international clinical trial comparing mobility training commenced <24 hours poststroke, termed very early mobilization (VEM), to usual care (UC). Primary outcome was assessed at 3 months. Patients with ischemic or hemorrhagic stroke within 24 hours of onset were included. Treatment with thrombolytics was allowed. Patients with severe premorbid disability or comorbidities were excluded. Interventions continued for 14 days or hospital discharge if less. The primary early safety outcome was fatal SAEs within 14 days. Secondary outcomes were nonfatal SAEs classified as neurologic, immobility-related, and other. Mortality influences were assessed using binary logistic regression adjusted for baseline stroke severity (NIH Stroke Scale [NIHSS] score) and age. RESULTS: A total of 2,104 participants were randomized to VEM (n = 1,054) or UC (n = 1,050) with a median age of 72 years (interquartile range [IQR] 63-80) and NIHSS 7 (IQR 4-12). By 14 days, 48 had died in VEM, 32 in UC, age and stroke severity adjusted odds ratio of 1.76 (95% confidence interval 1.06-2.92, p = 0.029). Stroke progression was more common in VEM. Exploratory subgroup analyses showed higher odds of death in intracerebral hemorrhage and >80 years subgroups, but there was no significant treatment by subgroup interaction. No difference in nonfatal SAEs was found. CONCLUSION: While the overall case fatality at 14 days poststroke was only 3.8%, mortality adjusted for age and stroke severity was increased with high dose and intensive training compared to usual care. Stroke progression was more common in VEM. REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12606000185561. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that very early mobilization increases mortality at 14 days poststroke.
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    Factors associated with improved walking in older people during hospital rehabilitation: secondary analysis of a randomized controlled trial
    Said, CM ; McGinley, JL ; Szoeke, C ; Workman, B ; Hill, KD ; Wittwer, JE ; Woodward, M ; Liew, D ; Churilov, L ; Bernhardt, J ; Morris, ME (BMC, 2021-01-31)
    BACKGROUND: Older people are often admitted for rehabilitation to improve walking, yet not everyone improves. The aim of this study was to determine key factors associated with a positive response to hospital-based rehabilitation in older people. METHODS: This was a secondary data analysis from a multisite randomized controlled trial. Older people (n= 198, median age 80.9 years, IQR 76.6- 87.2) who were admitted to geriatric rehabilitation wards with a goal to improve walking were recruited. Participants were randomized to receive additional daily physical therapy focused on mobility (n = 99), or additional social activities (n = 99). Self-selected gait speed was measured on admission and discharge. Four participants withdrew. People who changed gait speed ≥0.1 m/s were classified as 'responders' (n = 130); those that changed <0.1m/s were classified as 'non-responders' (n = 64). Multivariable logistic regression explored the association of six pre-selected participant factors (age, baseline ambulation status, frailty, co-morbidities, cognition, depression) and two therapy factors (daily supervised upright activity time, rehabilitation days) and response. RESULTS: Responding to rehabilitation was associated with the number of days in rehabilitation (OR 1.04; 95% CI 1.00 to 1.08; p = .039) and higher Mini Mental State Examination scores (OR 1.07, 95% CI 1.00 - 1.14; p = .048). No other factors were found to have association with responding to rehabilitation. CONCLUSION: In older people with complex health problems or multi-morbidities, better cognition and a longer stay in rehabilitation were associated with a positive improvement in walking speed. Further research to explore who best responds to hospital-based rehabilitation and what interventions improve rehabilitation outcomes is warranted. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12613000884707; ClinicalTrials.gov Identifier NCT01910740 .