Lara Edbrooke

Exercise rehabilitation for patients with critical illness: a randomized controlled trial with 12 months of follow-up

IntroductionThe purpose of this trial was to investigate the effectiveness of an exercise rehabilitation program commencing during ICU admission and continuing into the outpatient setting compared with usual care on physical function and health-related quality of life in ICU survivors.MethodsWe conducted a single-center, assessor-blinded, randomized controlled trial. One hundred and fifty participants were stratified and randomized to receive usual care or intervention if they were in the ICU for 5 days or more and had no permanent neurological insult. The intervention group received intensive exercises in the ICU and the ward and as outpatients. Participants were assessed at recruitment, ICU admission, hospital discharge and at 3-, 6- and 12-month follow-up. Physical function was evaluated using the Six-Minute Walk Test (6MWT) (primary outcome), the Timed Up and Go Test and the Physical Function in ICU Test. Patient-reported outcomes were measured using the Short Form 36 Health Survey, version 2 (SF-36v2) and Assessment of Quality of Life (AQoL) Instrument. Data were analyzed using mixed models.ResultsThe a priori enrollment goal was not reached. There were no between-group differences in demographic and hospital data, including acuity and length of acute hospital stay (LOS) (Acute Physiology and Chronic Health Evaluation II score: 21 vs 19; hospital LOS: 20 vs 24 days). No significant differences were found for the primary outcome of 6MWT or any other outcomes at 12 months after ICU discharge. However, exploratory analyses showed the rate of change over time and mean between-group differences in 6MWT from first assessment were greater in the intervention group.ConclusionsFurther research examining the trajectory of improvement with rehabilitation is warranted in this population.Trial registrationThe trial was registered with the Australian New Zealand Clinical Trials Registry ACTRN12605000776606.

A Physical Function Test for Use in the Intensive Care Unit: Validity, Responsiveness, and Predictive Utility of the Physical Function ICU Test (Scored)

Background Several tests have recently been developed to measure changes in patient strength and functional outcomes in the intensive care unit (ICU). The original Physical Function ICU Test (PFIT) demonstrates reliability and sensitivity. Objective The aims of this study were to further develop the original PFIT, to derive an interval score (the PFIT-s), and to test the clinimetric properties of the PFIT-s. Design A nested cohort study was conducted. Methods One hundred forty-four and 116 participants performed the PFIT at ICU admission and discharge, respectively. Original test components were modified using principal component analysis. Rasch analysis examined the unidimensionality of the PFIT, and an interval score was derived. Correlations tested validity, and multiple regression analyses investigated predictive ability. Responsiveness was assessed using the effect size index (ESI), and the minimal clinically important difference (MCID) was calculated. Results The shoulder lift component was removed. Unidimensionality of combined admission and discharge PFIT-s scores was confirmed. The PFIT-s displayed moderate convergent validity with the Timed “Up & Go” Test (r=−.60), the Six-Minute Walk Test (r=.41), and the Medical Research Council (MRC) sum score (rho=.49). The ESI of the PFIT-s was 0.82, and the MCID was 1.5 points (interval scale range=0–10). A higher admission PFIT-s score was predictive of: an MRC score of ≥48, increased likelihood of discharge home, reduced likelihood of discharge to inpatient rehabilitation, and reduced acute care hospital length of stay. Limitations Scoring of sit-to-stand assistance required is subjective, and cadence cutpoints used may not be generalizable. Conclusions The PFIT-s is a safe and inexpensive test of physical function with high clinical utility. It is valid, responsive to change, and predictive of key outcomes. It is recommended that the PFIT-s be adopted to test physical function in the ICU.

Evaluation of Exercise Rehabilitation for Survivors of Intensive Care: Protocol for a Single Blind Randomised Controlled Trial

Introduction: Intensive care (ICU) survivors have poor quality of life (QoL) and physical outcomes compared to people of the same age and sex (1). Although rehabilitation of patients in ICU is now advocated as routine clinical prac- tice (2) there are few randomised controlled trials (RCTs) examining patient outcomes. The primary aim of this single blind randomised controlled trial is to investigate the efficacy of a comprehensive rehabilitation intervention begun in ICU compared to standard care on health related quality of life (HRQoL) and physical function. Method: Participants who have been in one tertiary ICU for � 5 days, aged � 18 years, who can understand written and spoken English, will be randomly allocated to receive either standard care or a comprehensive physiotherapy rehabilita- tion program beginning in ICU and continuing upon discharge to the ward and as an out patient (OP). Blinded assessment of the primary outcome measures physical function, health status and HRQoL will be performed at baseline, 3, 6 and 12 months after discharge. Physical function measures will be obtained at ICU and hospital discharge and for the intervention group, pre and post OP classes. The intervention will include individualised exercises prescribed by physiotherapists in ICU and on the ward and given by an exercise physiologist and physiotherapist in OP. Results: We aim to enrol 200 participants over two years. The study will determine whether comprehensive physiotherapy rehabilitation from ICU to discharge and OP attendance will improve physical functioning, health status and quality of life in critical care survivors. The cost utility (CUA) and cost effectiveness of such a program will also be evaluated using util- ity scores and a purpose designed economics questionnaire. Secondary outcomes related to proxy and subject HRQoL comparisons, mechanical ventilation, critical illness neuromyopathy, ICU readmission and discharge destination will also be examined. Conclusion: The outcomes measured are of significance to critical care patients. The CUA of the intervention will be of interest to health service providers. The results will enable development of clinical practice guidelines for the appropriate exercises in survivors of ICU. Registered with the Australian and New Zealand Clinical Trials Network (ACTRN 12605000776606).

Quantifying Physical Activity Levels of Survivors of Intensive Care: A Prospective Observational Study

Background Promotion of increased physical activity is advocated for survivors of an intensive care unit (ICU) admission to improve physical function and health-related quality of life. Objective The primary aims of this study were: (1) to measure free-living physical activity levels and (2) to correlate the measurements with scores on a self-reported activity questionnaire. A secondary aim was to explore factors associated with physical activity levels. Design This was a prospective cohort study. Methods Nested within a larger randomized controlled trial, participants were block randomized to measure free-living physical activity levels. Included participants wore an accelerometer for 7 days during waking hours at 2 months after ICU discharge. At completion of the 7 days of monitoring, participants were interviewed using the Physical Activity Scale for the Elderly (PASE) questionnaire. Factors associated with physical activity were explored using regression analysis. Results The ICU survivors (median age=59 years, interquartile range=49–66; mean Acute Physiologic Chronic Health Evaluation [APACHE II] score=18, interquartile range=16–21) were inactive when quantitatively measured at 2 months after hospital discharge. Participants spent an average of 90% of the time inactive and only 3% of the time walking. Only 37% of the sample spent 30 minutes or more per day in the locomotion category (more than 20 steps in a row). Activity reported using the PASE questionnaire was lower than that reported in adults who were healthy. The PASE scores correlated only fairly with activity measured by steps per day. The presence of comorbidities explained one third of the variance in physical activity levels. Limitations Accelerometer overreading, patient heterogeneity, selection bias, and sample size not reached were limitations of the study. Conclusions Survivors of an ICU admission greater than 5 days demonstrated high levels of inactivity for prolonged periods at 2 months after ICU discharge, and the majority did not meet international recommendations regarding physical activity. Comorbidity appears to be a promising factor associated with activity levels.

Deterioration in physical activity and function differs according to treatment type in non-small cell lung cancer – future directions for physiotherapy management

OBJECTIVES To investigate in non-surgically and surgically treated non-small cell lung cancer (NSCLC): (1) changes in physical activity, function, health-related quality of life (HRQoL) and symptoms after diagnosis; and (2) the association between physical activity and outcomes. DESIGN Prospective observational study. SETTING Three acute tertiary hospitals. PARTICIPANTS Sixty-nine individuals (43 male, median [IQR] age 68 [61 to 74] years) with stage I-IV NSCLC. MAIN OUTCOME MEASURES The primary outcome (Physical Activity Scale for the Elderly) and secondary outcome (six-minute walk test and questionnaires assessing HRQoL, function, symptoms, mood) were measured at diagnosis (pre-treatment), and eight to ten weeks post-diagnosis (post-operative and/or during chemotherapy/radiotherapy). RESULTS Individuals treated surgically (n=27) experienced a deterioration in physical activity levels (baseline median [IQR]=74 [51 to 135]; follow-up median [IQR]=29 [24 to 73]; median difference=45, effect size=0.3). At follow-up physical activity was inversely related to depression, pain and appetite loss (rho>0.5, p<0.05). In contrast non-surgical individuals (n=42) did not experience a change in physical activity, however did experience deterioration in function, functional capacity, global HRQoL, fatigue and dyspnoea. Physical activity levels were low in this group and at follow-up the strongest relationships with physical activity levels were global HRQoL, function, fatigue and mood (inverse, rho>0.5, p<0.05). CONCLUSIONS Surgically treated individuals experienced a reduction in physical activity levels after diagnosis, which was not seen in the non-surgical group. Lower physical activity levels were associated with poorer outcomes, particularly in non-surgically treated individuals. Further research is required to establish the optimal intervention to improve physical activity levels in these cohorts.

How is physical activity measured in lung cancer?A systematic review of outcome measures and their psychometric properties.

Physical activity (PA) levels are low in patients with lung cancer. Emerging evidence supports the use of interventions to increase PA in this population. We aimed to (1) identify and synthesize outcome measures which assess PA levels in patients with lung cancer and (2) to evaluate, synthesize and compare the psychometric properties of these measures. A systematic review of articles from searches was conducted of five electronic databases and personal records. Eligible studies were those which assessed PA using either performance‐based or patient‐reported measures. For aim 2, studies identified in aim 1 reporting on at least one psychometric property (validity, reliability, responsiveness or measurement error) were included. Two independent reviewers assessed eligibility and risk of bias with the COnsensus‐based Standards for the selection of health status Measurement INstruments.

Measurement of physical activity levels in the Intensive Care Unit and functional outcomes: An observational study

Purpose Primary aims were: (1) objectively quantify levels of physical activity with the sensewear armband mini‐fly motion sensor (SWA‐MF), (2) evaluate the correlation of SWA‐MF measurement of active and resting energy expenditure against the ICU Mobility scale (IMS) and indirect calorimetry respectively. Materials and methods Adults mechanically ventilated ≥ 48 h and anticipated to remain in ICU ≥ 5 days were included. Physical activity (PA) was measured using a SWA‐MF (over the first five days); energy expenditure was measured with both the SWA‐MF and the Deltatrac II metabolic cart on day three; highest level of mobility was assessed on the IMS. Results Fifty‐five participants performed median [IQR] 16.8 [0.6–152.4] minutes of PA per day (defined as > 1.0 metabolic equivalent). A strong correlation between active energy expenditure and highest level of mobility (IMS), r = 0.76, p = 0.00 was observed on day 5. The SWA‐MF demonstrated moderate to good agreement with the Deltatrac II metabolic cart (n = 20), intra‐class correlation co‐efficient = 0.71 (p = 0.00) for the measurement of energy expenditure on day 3. Conclusions Participants demonstrated low levels of PA. Motion sensors may be a promising non‐invasive measure of energy expenditure and further investigation is warranted. HighlightsLow levels of physical activity are performed early in the intensive care unit stay when measured with a motion sensorMeasurement of resting and active energy expenditure with a motion sensor device demonstrates moderate to good agreement with indirect calorimetry and the ICU mobility scale respectivelyUse of motion sensor devices is safe and feasible in the critical care setting

Can an Accelerometer-Based Monitor be used to Accurately Assess Physical Activity in a Population of Survivors of Critical Illness?

Purpose: To investigate the validity and reliability of the Activity Monitoring Pod (AMP331) to record gait parameters in healthy young adults (YA) and intensive care unit inpatients (ICU). Methods: YA (N=15) completed a series of over-ground walks. Another 15 YA completed a series of treadmill walks. The ICU group (N=20) completed a series of over-ground walks with repeat trials. Gait parameters were recorded simultaneously by the AMP 331 and the Vicon (YA) and the AMP 331, direct observation and a stopwatch (ICU). Results: For the YA over-ground, no significant differences were found between the measures recorded by the systems. For the YA treadmill, 43% of the measures differed (P < .05). For the ICU group, the AMP331 underestimated distance and speed by 3m and 25cm/s respectively. Reliability measures (ICU group) for distance (ICC 0.99, 95%CI 0.98 – 0.99) and step count (ICC 0.99, 95%CI 0.99 – 1.00) were excellent. Conclusions: The AMP 331 is a valid instrument for recording basic gait parameters for over-ground walking in healthy YA and ICU survivors.

Benefits of home-based multidisciplinary exercise and supportive care in inoperable non-small cell lung cancer – protocol for a phase II randomised controlled trial

BackgroundLung cancer is one of the most commonly diagnosed cancers, and is a leading cause of cancer mortality world-wide. Due to lack of early specific symptoms, the majority of patients present with advanced, inoperable disease and five-year relative survival across all stages of non-small cell lung cancer (NSCLC) is 14%. People with lung cancer also report higher levels of symptom distress than those with other forms of cancer. Several benefits for survival and patient reported outcomes are reported from physical activity and exercise in other tumour groups. We report the protocol for a study investigating the benefits of exercise, behaviour change and symptom self-management for patients with recently diagnosed, inoperable, NSCLC.MethodsThis multi-site, parallel-group, assessor-blinded randomised controlled trial, powered for superiority, aims to assess functional and patient-reported outcomes of a multi-disciplinary, home-based exercise and supportive care program for people commencing treatment. Ninety-two participants are being recruited from three tertiary-care hospitals in Melbourne, Australia. Following baseline testing, participants are randomised using concealed allocation, to receive either: a) 8 weeks of home-based exercise (comprising an individualised endurance and resistance exercise program and behaviour change coaching) and nurse-delivered symptom self-management intervention or b) usual care. The primary outcome is the between-group difference in the change in functional exercise capacity (six-minute walk distance) from baseline to post-program assessment. Secondary outcomes include: objective and self-reported physical activity levels, physical activity self-efficacy, behavioural regulation of motivation to exercise and resilience, muscle strength (quadriceps and grip), health-related quality of life, anxiety and depression and symptom interference.DiscussionThere is a lack of evidence regarding the benefit of exercise intervention for people with NSCLC, particularly in those with inoperable disease receiving treatment. This trial will contribute to evidence currently being generated in national and international trials by implementing and evaluating a home-based program including three components not yet combined in previous research, for people with inoperable NSCLC receiving active treatment and involving longer-term follow-up of outcomes. This trial is ongoing and currently recruiting.Trial registrationThis trial was prospectively registered on the Australian New Zealand Clinical Trials Registry (ACTRN12614001268639: (4/12/14).

CAPACITY: A physical activity self-management program for patients undergoing surgery for lung cancer, a phase I feasibility study

OBJECTIVES Physical activity is important in lung cancer, yet the majority of patients do not meet minimum weekly recommended activity levels. The objectives of this study were to determine the: 1) feasibility and 2) exploratory effectiveness of a physical activity self-management program aiming to increase physical activity levels of patients undergoing surgery for lung cancer. MATERIALS AND METHODS Prospective case series including patients with operable lung cancer. The physical activity self-management program, based on international cancer physical activity guidelines, commenced pre-operative (if recruitment occurred ≥7 days before surgery) or post-operative if not, and continued until 8-weeks after surgery. The program included prescription of an unsupervised home aerobic exercise program, taught in an initial face-to-face consultation and followed-up with weekly telephone consultations. This was supplemented with patient education, behaviour change techniques and provision of an activity monitor. The primary endpoint was program feasibility including consent rate and number of consultations delivered. In addition, self-reported physical activity levels, self-efficacy for physical activity, health-related quality of life (HRQoL) and mood was assessed pre- and 8-weeks post-operative. RESULTS The consent rate was 89%. Thirty-seven patients (54% male, mean age 66 ± 10 years) were included. Only six participants commenced the program before surgery, with most (n = 31) commencing post-operatively. The median [IQR] number of consultations was 4 [3-6] per participant. There was no change in physical activity levels (total estimated mets/week pre-operative median [IQR] 1066 [0-2772], 8 weeks post-operative 924 [346-1752], p = 0.545) or sedentary time (television viewing hours/day pre-operative 4.5 [2.0-9.5], 8-weeks 4.0 [3.0-5.0], p = 0.527) after surgery. CONCLUSION The physical activity program was feasible when implemented in the post-operative setting. Participants in this feasibility study demonstrated maintenance in physical activity levels 8-weeks after surgery, compared with published literature reporting decline after surgery. A randomised controlled trial is warranted to further investigate potential effectiveness of this intervention.