Research lessons during the COVID-19 pandemic: collecting longitudinal physical and mental health outcomes.

BACKGROUND: Participant enrolment, assessment and/or delivery of intervention in many clinical trials during the COVID-19 pandemic were severely impacted by public health measures limiting physical contact. This report describes the lessons learned in completing a repeated measures cohort study involving suspected and confirmed COVID-19 survivors at three sites in Perth, Western Australia. MAIN BODY: An observational analysis of the conduct and data completeness results of the LATER-19 trial. People with COVID19 symptoms who were tested between February and November 2020 were recruited. In both those who tested positive and those who tested negative (control group) for COVID19, data on physical function and mental health were collected at two time points up to eight months after COVID19 testing. Recruitment of the controls was targeted from hospital records for comparison, it was balanced for age and sex and for the non-hospitalised group also comorbidities. A sample of 344 participants was recruited: 155 (45.1%) COVID-19 positive. Taking the research design and environmental adaptations into account, we recorded > 90% participant engagement during the trial. Of the 637 planned assessments, objective measures were completed on 602 (94.5%) occasions; 543 (90.2%) were on-site and 59 (9.8%) were remote. A total of 577 (90.6%) mental health/symptoms surveys, 569 (89.3%) 1-min sit-to-stand tests, and 520 (81.6%) handgrip strength tests were completed. CONCLUSION: The sample size and high completion rate of planned assessments during the LATER-19 trial potentially increases the contextual, groupwise generalisability of the results. The results demonstrate the effectiveness of a simple, rapid, reproducible and adaptable battery of assessments, leveraging telehealth and digital solutions. TRIAL REGISTRATION NUMBER: Australian and New Zealand Clinical Trial Registration (ANZCTR): ACTRN12621001067864 .

Exercise training for adults hospitalized with an acute respiratory condition: a systematic scoping review.

OBJECTIVE: In adults hospitalized with an acute or chronic respiratory condition, to determine what has been reported regarding exercise programmes in terms of content, tolerability, evaluation and adverse events. DATA SOURCES: A systematic search was conducted of electronic databases (PubMed, EMBASE, CINAHL, PEDro, The Cochrane Library), trial registries and conference abstracts (Thoracic Society of Australia and New Zealand Annual Scientific Meeting, the European Respiratory Society Congress, the American Thoracic Society International Conference). REVIEW METHODS: Studies were included if they (1) recruited adults hospitalized with an acute or chronic respiratory condition, (2) described an exercise programme that targeted peripheral muscles and (3) reported that ⩾80% of the sample had initiated training within 72 hours of hospitalization. RESULTS: The last search was conducted on 2 June 2019. Of the 6282 records identified, 20 met the study criteria. These described 18 separate studies (2018 participants). Studies were conducted in adults hospitalized with an exacerbation of chronic obstructive pulmonary disease or with community-acquired pneumonia. The content of exercise programmes included aerobic and/or resistance training, neuromuscular electrical stimulation, whole-body vibration or movement out of bed. In eight studies (44%), the initial session was prescribed using objective measures of exercise capacity, peripheral muscle force and the ability to undertake activities of daily living. Across 7420 training sessions, seven adverse events were reported. CONCLUSION: Methods used to prescribe and titrate exercise programmes in adults hospitalized with an acute or an exacerbation of a chronic respiratory condition were disparate. When reported, programmes were well tolerated and adverse events were infrequent.

Reduced Step Count and Clinical Frailty in Hospitalized Adults With Community-Acquired Pneumonia.

BACKGROUND: In adults hospitalized with community-acquired pneumonia (CAP), increasing ward-based walking may reduce length of stay (LOS). There are few data to describe ward-based walking in this population. In adults hospitalized with CAP, we aimed to report variables of walking and non-walking time, to determine whether demographic or clinical variables influenced daily step count, and to determine whether daily step count influenced LOS. METHODS: Following admission, daily step count and variables related to walking and non-walking time were quantified using the StepWatch Activity Monitor. Details regarding demographics, clinical characteristics, clinical care, and LOS were extracted from the medical records and hospital electronic data systems. Frailty was calculated via the 7-point Clinical Frailty Scale; disease severity was measured via the CURB-65 score. Health care utilization at 30 d following discharge was measured via telephone interview. RESULTS: Two hundred participants completed the study, of whom 121 contributed ≥ 24 h of data from the StepWatch Activity Monitor. The median (interquartile range (IQR)) number of daily steps was 926 (457-1706). These were accumulated over 66 (41-121) min/d, with a usual bout duration of 3 (2-4) min and 1-min peak cadence of 56 (43-74) steps/min. An average of 93% (89-96) of waking hours was spent in non-walking time. In the multivariable model, increased frailty was retained as a predictor of lower step count (incidence rate ratio [IRR] 0.59, 95% CI 0.41-0.85). For every increase in 500 steps/d, LOS reduced by 11% (IRR 0.89, 95% CI 0.80-0.99). CONCLUSIONS: Subjects hospitalized with CAP did very little walking, most of which was accumulated in short bouts at a low intensity. Compared with subjects with mild frailty, those with moderate to severe frailty took 59% fewer steps per day. Those with a higher daily step count had a shorter LOS.

Effectiveness of interventions aiming at reducing sedentary behaviour in a non-surgical population with overweight or obesity: A systematic review and meta-analysis.

AIM: This systematic review and meta-analyses of randomised controlled trials (RCTs) investigated the effectiveness of interventions to reduce sedentary behaviour amongst people with overweight or obesity. Secondarily, it aimed to investigate the effectiveness of these interventions on body mass index (BMI), time spent in moderate-to-vigorous physical activity (MVPA) and health-related quality of life (HRQoL). METHODS: A search of six databases (CENTRAL, PubMed, Embase, PEDro, CINAHL and PsycINFO) was conducted from inception to July 2018. RCTs in which sedentary behaviour was measured by accelerometry or inclinometry, with participants of any age with overweight or obesity were included. Subgroup analyses were undertaken comparing studies that included adults versus children and studies with an active component (e.g., treadmill desk, physically active breaks) versus no active component to their intervention. RESULTS: Nine studies (n=1859) were included. Compared to the control group, the interventions significantly reduced time spent in sedentary behaviour (standardised mean difference [95% confidence interval] -0.33 [-0.59 to -0.08] overall; -0.53 [-0.95 to -0.11] in adults). Subgroup analyses demonstrated that only interventions that included active components reduced time spent in sedentary behaviour (-0.54 [-0.88 to -0.20]) and increased time spent in MVPA (1.29 [0.02 to 2.56]). Subgroup analyses demonstrated that interventions only reduced BMI in studies of children (-0.09 [-0.18 to -0.00]) and in those with no active component (-0.09 [-0.18 to -0.01]). There were insufficient data to investigate the effectiveness of these interventions on HRQoL. CONCLUSIONS: This novel systematic review and meta-analyses suggests interventions aiming to effectively reduce objectively-measured sedentary behaviour need to specifically include an active component.

The influence of a full-time, immersive simulation-based clinical placement on physiotherapy student confidence during the transition to clinical practice.

BACKGROUND: Novice students may have limited learning opportunities during their early exposure to complex clinical environments, due to the priorities of patient care. Immersive, high-fidelity simulation provides an opportunity for physiotherapy students to be exposed to relatively complex scenarios in a safe learning environment before transitioning to the clinical setting. The present study evaluated the influence of immersive simulation on student confidence and competence. METHODS: Sixty penultimate year physiotherapy students completed an 18-day full-time immersive simulation placement. The placement involved students spending 6 days working in each of three core practice areas (cardiopulmonary, musculoskeletal, neurological) in which they interacted with simulated patients portrayed by professional role-play actors. The patient scenarios were developed by groups of expert practitioners and incorporated full documentary and imaging information. Students completed a questionnaire to evaluate their confidence in the clinical environment at the start and completion of each 6-day rotation. Their clinical competence was evaluated at the end of each 6-day rotation using the Assessment of Physiotherapy Practice (APP) tool. In a secondary analysis, the clinical competence of this cohort was evaluated in comparison to a matched cohort of students from the same year group that had not completed an immersive simulation placement. RESULTS: Student confidence improved significantly in each 6-day rotation (p < 0.001); however, it reduced again at the commencement of the next rotation, and there was no cumulative improvement in confidence over the 18-day placement (p = 0.22). Students who had completed the immersive simulation placement achieved higher APP (p < 0.001) scores in an evaluation of their competence to practice during their subsequent clinical placement. CONCLUSION: Immersive simulation provides a beneficial learning environment to enable physiotherapy students to transition from university-based education to working in the clinical environment.

A Binational Multicenter Pilot Feasibility Randomized Controlled Trial of Early Goal-Directed Mobilization in the ICU.

OBJECTIVES: To determine if the early goal-directed mobilization intervention could be delivered to patients receiving mechanical ventilation with increased maximal levels of activity compared with standard care. DESIGN: A pilot randomized controlled trial. SETTING: Five ICUs in Australia and New Zealand. PARTICIPANTS: Fifty critically ill adults mechanically ventilated for greater than 24 hours. INTERVENTION: Patients were randomly assigned to either early goal-directed mobilization (intervention) or to standard care (control). Early goal-directed mobilization comprised functional rehabilitation treatment conducted at the highest level of activity possible for that patient assessed by the ICU mobility scale while receiving mechanical ventilation. MEASUREMENTS AND MAIN RESULTS: The ICU mobility scale, strength, ventilation duration, ICU and hospital length of stay, and total inpatient (acute and rehabilitation) stay as well as 6-month post-ICU discharge health-related quality of life, activities of daily living, and anxiety and depression were recorded. The mean age was 61 years and 60% were men. The highest level of activity (ICU mobility scale) recorded during the ICU stay between the intervention and control groups was mean (95% CI) 7.3 (6.3-8.3) versus 5.9 (4.9-6.9), p = 0.05. The proportion of patients who walked in ICU was almost doubled with early goal-directed mobilization (intervention n = 19 [66%] vs control n = 8 [38%]; p = 0.05). There was no difference in total inpatient stay (d) between the intervention versus control groups (20 [15-35] vs 34 [18-43]; p = 0.37). There were no adverse events. CONCLUSIONS: Key Practice Points: Delivery of early goal-directed mobilization within a randomized controlled trial was feasible, safe and resulted in increased duration and level of active exercises.

Early mobilization and recovery in mechanically ventilated patients in the ICU: a bi-national, multi-centre, prospective cohort study.

INTRODUCTION: The aim of this study was to investigate current mobilization practice, strength at ICU discharge and functional recovery at 6 months among mechanically ventilated ICU patients. METHOD: This was a prospective, multi-centre, cohort study conducted in twelve ICUs in Australia and New Zealand. Patients were previously functionally independent and expected to be ventilated for >48 hours. We measured mobilization during invasive ventilation, sedation depth using the Richmond Agitation and Sedation Scale (RASS), co-interventions, duration of mechanical ventilation, ICU-acquired weakness (ICUAW) at ICU discharge, mortality at day 90, and 6-month functional recovery including return to work. RESULTS: We studied 192 patients (mean age 58.1 ± 15.8 years; mean Acute Physiology and Chronic Health Evaluation (APACHE) (IQR) II score, 18.0 (14 to 24)). Mortality at day 90 was 26.6% (51/192). Over 1,351 study days, we collected information during 1,288 planned early mobilization episodes in patients on mechanical ventilation for the first 14 days or until extubation (whichever occurred first). We recorded the highest level of early mobilization. Despite the presence of dedicated physical therapy staff, no mobilization occurred in 1,079 (84%) of these episodes. Where mobilization occurred, the maximum levels of mobilization were exercises in bed (N = 94, 7%), standing at the bed side (N = 11, 0.9%) or walking (N = 26, 2%). On day three, all patients who were mobilized were mechanically ventilated via an endotracheal tube (N = 10), whereas by day five 50% of the patients mobilized were mechanically ventilated via a tracheostomy tube (N = 18). CONCLUSIONS: Early mobilization of patients receiving mechanical ventilation was uncommon. More than 50% of patients discharged from the ICU had developed ICU-acquired weakness, which was associated with death between ICU discharge and day-90. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT01674608. Registered 14 August 2012.

Expert consensus and recommendations on safety criteria for active mobilization of mechanically ventilated critically ill adults.

INTRODUCTION: The aim of this study was to develop consensus recommendations on safety parameters for mobilizing adult, mechanically ventilated, intensive care unit (ICU) patients. METHODS: A systematic literature review was followed by a meeting of 23 multidisciplinary ICU experts to seek consensus regarding the safe mobilization of mechanically ventilated patients. RESULTS: Safety considerations were summarized in four categories: respiratory, cardiovascular, neurological and other. Consensus was achieved on all criteria for safe mobilization, with the exception being levels of vasoactive agents. Intubation via an endotracheal tube was not a contraindication to early mobilization and a fraction of inspired oxygen less than 0.6 with a percutaneous oxygen saturation more than 90% and a respiratory rate less than 30 breaths/minute were considered safe criteria for in- and out-of-bed mobilization if there were no other contraindications. At an international meeting, 94 multidisciplinary ICU clinicians concurred with the proposed recommendations. CONCLUSION: Consensus recommendations regarding safety criteria for mobilization of adult, mechanically ventilated patients in the ICU have the potential to guide ICU rehabilitation whilst minimizing the risk of adverse events.

Feasibility and inter-rater reliability of the ICU Mobility Scale.

OBJECTIVES: The objectives of this study were to develop a scale for measuring the highest level of mobility in adult ICU patients and to assess its feasibility and inter-rater reliability. BACKGROUND: Growing evidence supports the feasibility, safety and efficacy of early mobilization in the intensive care unit (ICU). However, there are no adequately validated tools to quickly, easily, and reliably describe the mobility milestones of adult patients in ICU. Identifying or developing such a tool is a priority for evaluating mobility and rehabilitation activities for research and clinical care purposes. METHODS: This study was performed at two ICUs in Australia. Thirty ICU nursing, and physiotherapy staff assessed the feasibility of the 'ICU Mobility Scale' (IMS) using a 10-item questionnaire. The inter-rater reliability of the IMS was assessed by 2 junior physical therapists, 2 senior physical therapists, and 16 nursing staff in 100 consecutive medical, surgical or trauma ICU patients. RESULTS: An 11 point IMS scale was developed based on multidisciplinary input. Participating clinicians reported that the scale was clear, with 95% of respondents reporting that it took <1 min to complete. The junior and senior physical therapists showed the highest inter-rater reliability with a weighted Kappa (95% confidence interval) of 0.83 (0.76-0.90), while the senior physical therapists and nurses and the junior physical therapists and nurses had a weighted Kappa of 0.72 (0.61-0.83) and 0.69 (0.56-0.81) respectively. CONCLUSION: The IMS is a feasible tool with strong inter-rater reliability for measuring the maximum level of mobility of adult patients in the ICU.

Intensive care unit mobility practices in Australia and New Zealand: a point prevalence study.

OBJECTIVES: To develop a comprehensive set of items describing physiotherapy mobilisation practices for critically ill patients, and to document current practices in intensive care units in Australia and New Zealand, focusing on patients having > 48 hours of mechanical ventilation. DESIGN: Prospective, observational, multicentre, single-day, point prevalence study. PARTICIPANTS AND SETTING: All patients in 38 Australian and New Zealand ICUs at 10 am on one of three designated days in 2009 and 2010. MAIN OUTCOME MEASURES: Demographic data, admission diagnosis and mobilisation practices that had occurred in the previous 24 hours. RESULTS: 514 patients were enrolled, with 498 complete datasets. Mean age was 59.2 years (SD, 16.7 years) and 45% were mechanically ventilated. Mobilisation activities were classified into five categories that were not mutually exclusive: 140 patients (28%) completed an in-bed exercise regimen, 93 (19%) sat over the side of the bed, 182 (37%) sat out of bed, 124 (25%) stood and 89 (18%) walked. Predefined adverse events occurred on 24 occasions (5%). No patient requiring mechanical ventilation sat out of bed or walked. On the study day, 391 patients had been in ICU for > 48 hours. There were 384 complete datasets available for analysis and, of these, 332 patients (86%) were not walked. Of those not walked, 76 (23%) were in the ICU for ≥ 7 days. CONCLUSION: Patient mobilisation was shown to be low in a single-day point prevalence study. Future observational studies are required to confirm the results.

Clinical review: early patient mobilization in the ICU.

Early mobilization (EM) of ICU patients is a physiologically logical intervention to attenuate critical illness-associated muscle weakness. However, its long-term value remains controversial. We performed a detailed analytical review of the literature using multiple relevant key terms in order to provide a comprehensive assessment of current knowledge on EM in critically ill patients. We found that the term EM remains undefined and encompasses a range of heterogeneous interventions that have been used alone or in combination. Nonetheless, several studies suggest that different forms of EM may be both safe and feasible in ICU patients, including those receiving mechanical ventilation. Unfortunately, these studies of EM are mostly single center in design, have limited external validity and have highly variable control treatments. In addition, new technology to facilitate EM such as cycle ergometry, transcutaneous electrical muscle stimulation and video therapy are increasingly being used to achieve such EM despite limited evidence of efficacy. We conclude that although preliminary low-level evidence suggests that EM in the ICU is safe, feasible and may yield clinical benefits, EM is also labor-intensive and requires appropriate staffing models and equipment. More research is thus required to identify current standard practice, optimal EM techniques and appropriate outcome measures before EM can be introduced into the routine care of critically ill patients.