Improving physical movement during stroke rehabilitation: investigating associations between sleep measured by wearable actigraphy technology, fatigue, and key biomarkers.

BACKGROUND: Sleep disturbance and fatigue are common in individuals undergoing inpatient rehabilitation following stroke. Understanding the relationships between sleep, fatigue, motor performance, and key biomarkers of inflammation and neuroplasticity could provide valuable insight into stroke recovery, possibly leading to personalized rehabilitation strategies. This study aimed to investigate the influence of sleep quality on motor function following stroke utilizing wearable technology to obtain objective sleep measurements. Additionally, we aimed to determine if there were relationships between sleep, fatigue, and motor function. Lastly, the study aimed to determine if salivary biomarkers of stress, inflammation, and neuroplasticity were associated with motor function or fatigue post-stroke. METHODS: Eighteen individuals who experienced a stroke and were undergoing inpatient rehabilitation participated in a cross-sectional observational study. Following consent, participants completed questionnaires to assess sleep patterns, fatigue, and quality of life. Objective sleep was measured throughout one night using the wearable Philips Actiwatch. Upper limb motor performance was assessed on the following day and saliva was collected for biomarker analysis. Correlation analyses were performed to assess the relationships between variables. RESULTS: Participants reported poor sleep quality, frequent awakenings, and difficulties falling asleep following stroke. We identified a significant negative relationship between fatigue severity and both sleep quality (r=-0.539, p = 0.021) and participants experience of awakening from sleep (r=-0.656, p = 0.003). A significant positive relationship was found between grip strength on the non-hemiplegic limb and salivary gene expression of Brain-derived Neurotrophic Factor (r = 0.606, p = 0.028), as well as a significant negative relationship between grip strength on the hemiplegic side and salivary gene expression of C-reactive Protein (r=-0.556, p = 0.048). CONCLUSION: The findings of this study emphasize the importance of considering sleep quality, fatigue, and biomarkers in stroke rehabilitation to optimize recovery and that interventions may need to be tailored to the individual. Future longitudinal studies are required to explore these relationships over time. Integrating wearable technology for sleep and biomarker analysis can enhance monitoring and prediction of outcomes following stroke, ultimately improving rehabilitation strategies and patient outcomes.

Patients in isolation, their physical, environmental and mental health: An exploratory study.

BACKGROUND: Strict patient isolation in hospital is associated with adverse health outcomes. However, there is a lack of high-quality evidence for effective interventions to improve safety and quality of care for these patients. AIMS: To identify patient reported areas for improvement in the care of patients in hospital isolation and to determine the feasibility of collecting patient reported outcomes using validated tools. METHODS: Design An exploratory mixed methods study. Setting A major metropolitan teaching hospital in Melbourne, Australia. Participants Patients in hospital isolation for transmissible infections. Data collection Data were collected by (1) phone interviews with patients in isolation and (2) seven validated measurement tools to assess cognition, loneliness, nutritional status, quality of life, anxiety and depression and physical activity. Data were collected between September and December 2021. Data analysis Interviews were transcribed and analysed using thematic analysis. Quantitative data were analysed descriptively including participant characteristics and outcome data. RESULTS: Participants identified areas for improvement including activities to decrease boredom, more contact with staff to mitigate loneliness and increase comfort care, and formalised communication about clinical treatment and discharge plan. Patients with gastrointestinal symptoms were happier to be alone. There were operational challenges within the health service including delays and miscommunication. Only 70% of the participants completed all questionnaires. CONCLUSION: This study identified areas for improvement in care of patients in isolation and demonstrated that collecting patient reported outcomes using validated tools was feasible. The results of this research will inform development of an intervention to manage adverse effects. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: Patients in hospital isolation require additional consideration to ensure that their needs are met to avoid adverse outcomes. The patient experience and comfort can be negatively affected when fundamental care is lacking. REPORTING METHOD (EQUATOR): EQUATOR guidelines for Mixed Methods Reporting in Rehabilitation & Health Sciences (MMR-RHS). PATIENT OR PUBLIC CONTRIBUTION: Thirteen patients in hospital isolation agreed to participate in this study, sharing their experiences through interviews and assessment.

Understanding the workflow of nurses in acute and subacute medical wards: A time and motion study.

AIMS AND OBJECTIVES: The aim of this study was to determine how much time nurses spend on direct and indirect patient care in acute and subacute hospital settings. BACKGROUND: Quantifying direct and indirect nursing care provided during inpatient stay is vital to optimise the quality of care and manage resources. DESIGN: Time and motion cross-sectional observational study and reported the study according to the STROBE guideline. METHODS: Nurses working in an acute or subacute medical wards of a single health service participated. Nurses were observed twice for 2 h on the same day with an observer break in between sessions. Real-time task-related data were digitally recorded using the Work Observation Method By Activity Timing (WOMBAT) tool by a single research assistant. Frequency and time spent on pre-determined tasks were recorded and included direct care, indirect care, documentation, medication-related tasks, communication (professional) and other tasks. Task interruptions and multitasking were also recorded. RESULTS: Twenty-one nurses (acute n = 12, subacute n = 9) were observed during shifts between 7 AM and 9 PM in May-July 2021. A total of 7240 tasks were recorded. Nurses spent a third of their time on direct patient care (27% direct care and 3% medication administration). A total of 556 task interruptions occurred, mostly during documentation, and medication-related tasks. A further 1385 tasks were performed in parallel with other tasks, that is multitasking. CONCLUSIONS: Time spent on tasks was similar regardless of the setting and was consistent with previous research. We found differences in the distribution of tasks throughout the day between settings, which could have implications for workforce planning and needs to be investigated further. Interruptions occurred during documentation, direct care and medication-related tasks. Local-level strategies should be in place and regularly revised to reduce interruptions and prevent errors. Relevance to clinical practice The association between interruption and increased risk of error is well-established and should be an ongoing area of attention including observations and education provided in local settings.

Maintenance of Cardiorespiratory Fitness in People With Stroke: A Systematic Review and Meta-analysis.

OBJECTIVE: To determine if improvements in cardiorespiratory fitness are maintained in the short-, medium- and long-term after a cardiorespiratory fitness intervention in people with stroke. DATA SOURCES: MEDLINE, Cumulative Index to Nursing and Allied Health Literature, Embase, (CENTRAL) Cochrane, Web of Science, Sports Discus, and Physiotherapy Evidence Database were searched from inception. STUDY SELECTION: Randomized controlled trials and cohort studies including (1) people with stroke; (2) cardiorespiratory fitness interventions; (3) a direct measure of cardiorespiratory fitness; and (4) short- (0 to <3 months), medium- (3-6 months), or long-term (>6 months) follow-up data. DATA EXTRACTION: Two reviewers independently screened full texts and extracted data, including study methods, participant demographic information, stroke type and severity, outcome measures, intervention information, follow-up time points, and results, using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A lower limit of -1.0 mL•kg-1•min-1 was used to determine maintenance (ie, no change) of cardiorespiratory fitness. DATA SYNTHESIS: Fourteen studies (N=324 participants) were included. Participants completed cardiorespiratory fitness training 2-5 days per week over 4-13 weeks at moderate to high intensity (40%-70% heart rate reserve [HRR]; n=4 studies), high intensity (60% to <90% HRR; n=7 studies), and intervals of high intensity (85%-95% peak heart rate or maximal heart rate; n=3 studies). Most people with stroke did maintain cardiorespiratory fitness in the short- (-0.19 mL•kg-1•min-1 [95% CI, -1.66 to 1.28]), medium- (-0.61 mL•kg-1•min-1 [95% CI, -3.95 to 2.74]), and long-term (0.00 mL•kg-1•min-1 [95% CI, -2.23 to 2.23]) after completion of cardiorespiratory fitness interventions. CONCLUSIONS: People with stroke maintain cardiorespiratory fitness after a cardiorespiratory fitness intervention in the short-, medium-, and longer-term. However, little is known about the impact of participant and intervention characteristics on the long-term maintenance of cardiorespiratory fitness.

Timing and Dose of Upper Limb Motor Intervention After Stroke: A Systematic Review.

This systematic review aimed to investigate timing, dose, and efficacy of upper limb intervention during the first 6 months poststroke. Three online databases were searched up to July 2020. Titles/abstracts/full-text were reviewed independently by 2 authors. Randomized and nonrandomized studies that enrolled people within the first 6 months poststroke, aimed to improve upper limb recovery, and completed preintervention and postintervention assessments were included. Risk of bias was assessed using Cochrane reporting tools. Studies were examined by timing (recovery epoch), dose, and intervention type. Two hundred and sixty-one studies were included, representing 228 (n=9704 participants) unique data sets. The number of studies completed increased from one (n=37 participants) between 1980 and 1984 to 91 (n=4417 participants) between 2015 and 2019. Timing of intervention start has not changed (median 38 days, interquartile range [IQR], 22-66) and study sample size remains small (median n=30, IQR 20-48). Most studies were rated high risk of bias (62%). Study participants were enrolled at different recovery epochs: 1 hyperacute (<24 hours), 13 acute (1-7 days), 176 early subacute (8-90 days), 34 late subacute (91-180 days), and 4 were unable to be classified to an epoch. For both the intervention and control groups, the median dose was 45 (IQR, 600-1430) min/session, 1 (IQR, 1-1) session/d, 5 (IQR, 5-5) d/wk for 4 (IQR, 3-5) weeks. The most common interventions tested were electromechanical (n=55 studies), electrical stimulation (n=38 studies), and constraint-induced movement (n=28 studies) therapies. Despite a large and growing body of research, intervention dose and sample size of included studies were often too small to detect clinically important effects. Furthermore, interventions remain focused on subacute stroke recovery with little change in recent decades. A united research agenda that establishes a clear biological understanding of timing, dose, and intervention type is needed to progress stroke recovery research. Prospective Register of Systematic Reviews ID: CRD42018019367/CRD42018111629.

Effects of Aerobic Exercise on Serum Biomarkers of Neuroplasticity and Brain Repair in Stroke: A Systematic Review.

OBJECTIVE: To provide a novel overview of the literature and to summarize the evidence for the effects of aerobic exercise (AE) on serum biomarkers neuroplasticity and brain repair in survivors of stroke. DATA SOURCES: We conducted a systematic review and searched MEDLINE, Embase, and Cochrane CENTRAL using terms related to AE, neuroplasticity, brain repair, and stroke. STUDY SELECTION: Titles, abstracts, and selected full texts were screened by 2 independent reviewers against the following inclusion criteria: including adult survivors of stroke, completing an AE intervention working within the AE capacity, and measuring at least 1 blood biomarker outcome of interest. DATA EXTRACTION: Two independent reviewers extracted data and assessed risk of bias using Risk of Bias in Nonrandomized Studies-of Interventions and Cochrane's Risk of Bias 2 tools. DATA SYNTHESIS: Nine studies (n=215 participants) were included, reporting on the following outcomes: brain-derived neurotrophic factor (BDNF), insulin-like growth factor 1 (IGF-1), vascular endothelial growth factor (VEGF), cortisol, interleukin 6, and myeloperoxidase. A single bout of high-intensity interval training significantly increased BDNF, IGF-1, and VEGF levels, and a 40-45-minute, 24-session, continuous 8-week AE training program significantly increased BDNF levels. No significant difference in response to any other AE intervention was found in other serum biomarkers. CONCLUSIONS: AE can significantly increase BDNF, IGF-1, and VEGF across different AE protocols in survivors of stroke. However, more research is needed to determine the optimal exercise intensity and modalities, specifically in survivors of acute and subacute stroke, and how this may relate to functional outcomes.

Physical fitness training for stroke patients.

BACKGROUND: Levels of physical activity and physical fitness are low after stroke. Interventions to increase physical fitness could reduce mortality and reduce disability through increased function. OBJECTIVES: The primary objectives of this updated review were to determine whether fitness training after stroke reduces death, death or dependence, and disability. The secondary objectives were to determine the effects of training on adverse events, risk factors, physical fitness, mobility, physical function, health status and quality of life, mood, and cognitive function. SEARCH METHODS: In July 2018 we searched the Cochrane Stroke Trials Register, CENTRAL, MEDLINE, Embase, CINAHL, SPORTDiscus, PsycINFO, and four additional databases. We also searched ongoing trials registers and conference proceedings, screened reference lists, and contacted experts in the field. SELECTION CRITERIA: Randomised trials comparing either cardiorespiratory training or resistance training, or both (mixed training), with usual care, no intervention, or a non-exercise intervention in stroke survivors. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies, assessed quality and risk of bias, and extracted data. We analysed data using random-effects meta-analyses and assessed the quality of the evidence using the GRADE approach. Diverse outcome measures limited the intended analyses. MAIN RESULTS: We included 75 studies, involving 3017 mostly ambulatory participants, which comprised cardiorespiratory (32 studies, 1631 participants), resistance (20 studies, 779 participants), and mixed training interventions (23 studies, 1207 participants). Death was not influenced by any intervention; risk differences were all 0.00 (low-certainty evidence). There were few deaths overall (19/3017 at end of intervention and 19/1469 at end of follow-up). None of the studies assessed death or dependence as a composite outcome. Disability scores were improved at end of intervention by cardiorespiratory training (standardised mean difference (SMD) 0.52, 95% CI 0.19 to 0.84; 8 studies, 462 participants; P = 0.002; moderate-certainty evidence) and mixed training (SMD 0.23, 95% CI 0.03 to 0.42; 9 studies, 604 participants; P = 0.02; low-certainty evidence). There were too few data to assess the effects of resistance training on disability. Secondary outcomes showed multiple benefits for physical fitness (VO2 peak and strength), mobility (walking speed) and physical function (balance). These physical effects tended to be intervention-specific with the evidence mostly low or moderate certainty. Risk factor data were limited or showed no effects apart from cardiorespiratory fitness (VO2 peak), which increased after cardiorespiratory training (mean difference (MD) 3.40 mL/kg/min, 95% CI 2.98 to 3.83; 9 studies, 438 participants; moderate-certainty evidence). There was no evidence of any serious adverse events. Lack of data prevents conclusions about effects of training on mood, quality of life, and cognition. Lack of data also meant benefits at follow-up (i.e. after training had stopped) were unclear but some mobility benefits did persist. Risk of bias varied across studies but imbalanced amounts of exposure in control and intervention groups was a common issue affecting many comparisons. AUTHORS' CONCLUSIONS: Few deaths overall suggest exercise is a safe intervention but means we cannot determine whether exercise reduces mortality or the chance of death or dependency. Cardiorespiratory training and, to a lesser extent mixed training, reduce disability during or after usual stroke care; this could be mediated by improved mobility and balance. There is sufficient evidence to incorporate cardiorespiratory and mixed training, involving walking, within post-stroke rehabilitation programmes to improve fitness, balance and the speed and capacity of walking. The magnitude of VO2 peak increase after cardiorespiratory training has been suggested to reduce risk of stroke hospitalisation by ˜7%. Cognitive function is under-investigated despite being a key outcome of interest for patients. Further well-designed randomised trials are needed to determine the optimal exercise prescription, the range of benefits and any long-term benefits.

Determining Maximal Tolerable Aerobic Training Intensity in the Acute Phase after Stroke: a Novel Dose Ranging Trial Protocol.

INTRODUCTION: There is strong evidence that cardiorespiratory fitness (CRF) training improves fitness and mobility after stroke. Despite the large number of studies, the most efficacious dose is yet to be determined. Furthermore, the safety of early post-stroke training, while theoretically beneficial, remains uncertain. The aim of this study is to determine the maximum safe and tolerable intensity of CRF training early post-stroke. METHODS: This is a stratified (low to moderate exercise capacity), Phase I, 5+5 dose ranging trial protocol. Participants will be recruited within one month post-stroke and stratified by their exercise-capacity (i.e. low and moderate capacity). Cohorts of five participants will perform 12 interval-based training sessions for four-weeks at a pre-determined target-intensity. The intensity will increase in each consecutive cohort, in each stratum according to pre-defined rules until the maximum safe and tolerable intensity is reached, as determined by the occurrence of dose-limiting events and occurrence of adverse events. Dose-limiting events are defined as symptoms indicative of over-training including pain and inability to perform usual activities. STUDY OUTCOME: Maximum safe and tolerable intensity of CRF training in stroke survivors with low and moderate exercise capacity. DISCUSSION: This study is a first step in the systematic development of a CRF training intervention. We believe similar dose ranging designs may be useful for development of other rehabilitation interventions in different study populations.

The Impact of Physical Activity Before and After Stroke on Stroke Risk and Recovery: a Narrative Review.

PURPOSE OF THE REVIEW: Summarising the evidence for pre- and post-stroke physical activity (PA) and exercise to reduce stroke risk, and improve recovery and brain health. RECENT FINDINGS: Pre-stroke PA reduces the risk of stroke, and post-stroke PA and exercise reduce cardiovascular risk factors, which can moderate the risk of recurrent strokes. Pre-clinical evidence indicates that exercise enhances neuroplasticity. The results from clinical studies showed that exercise changes brain activity patterns in stroke survivors, which can be a signal neuroplasticity. The intensity of pre- and post-stroke PA and exercise is a key factor with higher intensities leading to greater benefits, including improvement in fitness. Having low fitness levels is an independent predictor for increased risk of stroke. Higher intensity leads to greater benefits; however, the optimum intensity of PA and exercise is yet unknown and needs to be further investigated. Strategies to decrease sedentary behaviour and improve fitness need to be considered.

Early Mobilization After Stroke Is Not Associated With Cognitive Outcome.

Background and Purpose- We aimed to determine whether early mobilization after stroke affects subsequent cognitive function. Methods- AVERT (A Very Early Rehabilitation Trial) was an international, 56-site, phase 3 randomized controlled trial, conducted from 2006 to 2015. Participants were included if they were aged 18+, presented within 24 hours of stroke, and satisfied physiological limits for blood pressure, heart rate, and temperature. Participants were randomized to receive either usual stroke unit care or very early and more frequent mobilization in addition to usual stroke unit care. The Montreal Cognitive Assessment, scored 0 to 30, was introduced as a 3-month outcome during 2008. Results- Of the 2104 patients included in AVERT, 317 were assessed before the Montreal Cognitive Assessment's introduction. Of the remaining 1787, 1189 (66.5%) had complete Montreal Cognitive Assessment data, 456 (25.5%) had partially or completely missing data, 136 (7.6%) had died, and 6 (0.3%) were lost to follow-up. In surviving participants with complete data, adjusting for age and stroke severity, total Montreal Cognitive Assessment score was no different in the intervention (n=595; median, 23; interquartile range, 19-26; mean, 21.9; SD, 5.9) and usual care (n=594; median, 23; interquartile range, 19-26; mean, 21.8; SD, 5.9) groups ( P=0.68). Conclusions- Exposure to earlier and more frequent mobilization in the acute stage of stroke does not influence cognitive outcome at 3 months. This stands in contrast to the primary outcome from AVERT (modified Rankin Scale), where the intervention group had less favorable outcomes than controls. Clinical Trial Registration- URL: https://www.anzctr.org.au . Unique identifier: ACTRN12606000185561.

Activity monitors for increasing physical activity in adult stroke survivors.

BACKGROUND: Stroke is the third leading cause of disability worldwide. Physical activity is important for secondary stroke prevention and for promoting functional recovery. However, people with stroke are more inactive than healthy age-matched controls. Therefore, interventions to increase activity after stroke are vital to reduce stroke-related disability. OBJECTIVES: To summarise the available evidence regarding the effectiveness of commercially available, wearable activity monitors and smartphone applications for increasing physical activity levels in people with stroke. SEARCH METHODS: We searched the Cochrane Stroke Group Trials Register, CENTRAL, MEDLINE, Embase, CINAHL, SPORTDiscus, and the following clinical trial registers: WHO International Clinical Trials Registry Platform, Clinical Trials, EU Clinical Trial Register, ISRCTN Registry, Australian and New Zealand Clinical Trial Registry, and Stroke Trials Registry to 3 March 2018. We also searched reference lists, Web of Science forward tracking, and Google Scholar, and contacted trial authors to obtain further data if required. We did not restrict the search on language or publication status. SELECTION CRITERIA: We included all randomised controlled trials (RCTs) and randomised cross-over trials that included use of activity monitors versus no intervention, another type of intervention, or other activity monitor. Participants were aged 18 years or older with a diagnosis of stroke, in hospital or living in the community. Primary outcome measures were steps per day and time in moderate-to-vigorous intensity activity. Secondary outcomes were sedentary time, time spent in light intensity physical activity, walking duration, fatigue, mood, quality of life, community participation and adverse events. We excluded upper limb monitors that only measured upper limb activity. DATA COLLECTION AND ANALYSIS: We followed standard Cochrane methodology to analyse and interpret the data. At least two authors independently screened titles and abstracts for inclusion. We resolved disagreements by consulting a third review author. We extracted the following data from included studies into a standardised template: type of study, participant population, study setting, intervention and co-interventions, time-frame, and outcomes. We graded levels of bias as high, low, or unclear, and assessed the quality of evidence for each outcome using the GRADE approach. MAIN RESULTS: We retrieved 28,098 references, from which we identified 29 potential articles. Four RCTs (in 11 reports) met the inclusion criteria.The sample sizes ranged from 27 to 135 (total 245 participants). Time poststroke varied from less than one week (n = 1), to one to three months (n = 2), or a median of 51 months (n = 1). Stroke severity ranged from a median of one to six on the National Institutes of Health Stroke Scale (NIHSS). Three studies were conducted in inpatient rehabilitation, and one was in a university laboratory. All studies compared use of activity monitor plus another intervention (e.g. a walking retraining programme or an inpatient rehabilitation programme) versus the other intervention alone. Three studies reported on the primary outcome of daily step counts.There was no clear effect for the use of activity monitors in conjunction with other interventions on step count in a community setting (mean difference (MD) -1930 steps, 95% confidence interval (CI) -4410 to 550; 1 RCT, 27 participants; very low-quality evidence), or in an inpatient rehabilitation setting (MD 1400 steps, 95% CI -40 to 2840; 2 RCTs, 83 participants; very low-quality evidence). No studies reported the primary outcome moderate-to-vigorous physical activity, but one did report time spent in moderate and vigorous intensity activity separately: this study reported that an activity monitor in addition to usual inpatient rehabilitation increased the time spent on moderate intensity physical activity by 4.4 minutes per day (95% CI 0.28 to 8.52; 1 RCT, 48 participants; low-quality evidence) compared with usual rehabilitation alone, but there was no clear effect for the use of an activity monitor plus usual rehabilitation for increasing time spent in vigorous intensity physical activity compared to usual rehabilitation (MD 2.6 minutes per day, 95% CI -0.8 to 6; 1 RCT, 48 participants; low-quality evidence). The overall risk of bias was low, apart from high-risk for blinding of participants and study personnel. None of the included studies reported any information relating to adverse effects. AUTHORS' CONCLUSIONS: Only four small RCTs with 274 participants (three in inpatient rehabilitation and one in the community) have examined the efficacy of activity monitors for increasing physical activity after stroke. Although these studies showed activity monitors could be incorporated into practice, there is currently not enough evidence to support the use of activity monitors to increase physical activity after stroke.

The Energy Cost of Steady State Physical Activity in Acute Stroke.

OBJECTIVE: Cardiorespiratory fitness levels are very low after stroke, indicating that the majority of stroke survivors are unable to independently perform daily activities. Physical fitness training improves exercise capacity poststroke; however, the optimal timing and intensity of training is unclear. Understanding the energy cost of steady-state activity is necessary to guide training prescription early poststroke. We aimed to determine if acute stroke survivors can reach steady state (oxygen-uptake variability ≤2.0 mL O2/kg/min) during physical activity and if the energy cost of steady state activity differs from healthy controls. MATERIAL AND METHODS: We recruited 23 stroke survivors less than 2 weeks poststroke. Thirteen were able to walk independently and performed a 6-minute walk (median age 78 years, interquartile range [IQR] 70-85), and 7 who were unable to walk independently performed 6 minutes of continuous sit-to-stands (median age 78 years, IQR 74-79) and we recruited 10 healthy controls (median age 73 years, IQR 70-77) who performed both 6 minutes of walking and sit-to-stands. Our primary outcome was energy cost (oxygen-uptake) during steady state activity (i.e., walking and continuous) sit-to-stands, measured by a mobile metabolic cart. RESULTS: All stroke survivors were able to reach steady state. Energy costs of walking was higher in stroke than in controls (mean difference .10 mL O2/kg/m, P = .02); the difference in energy costs during sit-to-stands was not significant (mean difference .11 mL O2/kg/sts, P = .45). CONCLUSIONS: Acute stroke survivors can reach a steady state during activity, indicating they are able to perform cardiorespiratory exercise. Acute stroke survivors require more energy per meter walked than controls.

Energy Expenditure and Cost During Walking After Stroke: A Systematic Review.

OBJECTIVES: To systematically review the evidence to determine energy expenditure (EE) in volume of oxygen uptake (V̇O2) (mL/kg/min) and energy cost in oxygen uptake per meter walked (V̇O2/walking speed; mL/kg/m) during walking poststroke and how it compares with healthy controls; and to determine how applicable current exercise prescription guidelines are to stroke survivors. DATA SOURCES: Cochrane Central Register of Controlled Trials, MEDLINE, Embase, and CINAHL were searched on October 9, 2014, using search terms related to stroke and EE. Additionally, we screened reference lists of eligible studies. STUDY SELECTION: Two independent reviewers screened titles and abstracts of 2115 identified references. After screening the full text of 144 potentially eligible studies, we included 29 studies (stroke survivors: n=501, healthy controls: n=123), including participants with confirmed stroke and a measure of V̇O2 during walking using breath-by-breath analysis. Studies with (9 studies) and without (20 studies) a healthy control group were included. DATA EXTRACTION: Two reviewers independently extracted data using a standard template, including patient characteristics, outcome data, and study methods. DATA SYNTHESIS: Mean age of stroke survivors was 57 years (range, 40-67y). Poststroke EE was highly variable across studies and could not be pooled because of high heterogeneity. EE during steady-state overground walking at matched speeds was significantly higher in stroke survivors than healthy controls (mean difference in V̇O2, 4.06 mL/kg/min; 95% confidence interval [CI], 2.21-5.91; 1 study; n=26); there was no significant group difference at self-selected speeds. Energy cost during steady-state overground walking was higher in stroke survivors at both self-selected (mean difference, .47 mL/kg/m; 95% CI, .29-.66; 2 studies; n=38) and matched speeds compared with healthy controls (mean difference, .27 mL/kg/m; 95% CI, .03-.51; 1 study; n=26). CONCLUSIONS: Stroke survivors expend more energy during walking than healthy controls. Low-intensity exercise as described in guidelines might be at a moderate intensity level for stroke survivors; there is a need for stroke-specific exercise guidelines.

Reducing Sitting Time After Stroke: A Phase II Safety and Feasibility Randomized Controlled Trial.

OBJECTIVE: To test the safety, feasibility, and effectiveness of reducing sitting time in stroke survivors. DESIGN: Randomized controlled trial with attention-matched controls and blinded assessments. SETTING: Community. PARTICIPANTS: Stroke survivors (N=35; 22 men; mean age, 66.9±12.7y). INTERVENTIONS: Four counseling sessions over 7 weeks with a message of sit less and move more (intervention group) or calcium for bone health (attention-matched control group). MAIN OUTCOME MEASURES: Measures included safety (adverse events, increases in pain, spasticity, or fatigue) and feasibility (adherence to trial protocol). Secondary measures included time spent sitting (including in prolonged bouts ≥30min), standing, and stepping as measured by the thigh-worn inclinometer (7d, 24h/d protocol) and time spent in physical activity of at least moderate intensity as measured by a triaxial accelerometer. The Multimedia Activity Recall for Children and Adults was used to describe changes in use of time. RESULTS: Thirty-three participants completed the full protocol. Four participants reported falls during the intervention period with no other adverse events. From a baseline average of 640.7±99.6min/d, daily sitting time reduced on average by 30±50.6min/d (95% confidence interval [CI], 5.8-54.6) in the intervention group and 40.4±92.5min/d in the control group (95% CI, 13.0-93.8). Participants in both groups also reduced their time spent in prolonged sitting bouts (≥30min) and increased time spent standing and stepping. CONCLUSIONS: Our protocol was both safe and feasible. Participants in both groups spent less time sitting and more time standing and stepping postintervention, but outcomes were not superior for intervention participants. Attention matching is desirable in clinical trials and may have contributed to the positive outcomes for control participants.

Electrotherapy modalities for adhesive capsulitis (frozen shoulder).

BACKGROUND: Adhesive capsulitis (also termed frozen shoulder) is a common condition characterised by spontaneous onset of pain, progressive restriction of movement of the shoulder and disability that restricts activities of daily living, work and leisure. Electrotherapy modalities, which aim to reduce pain and improve function via an increase in energy (electrical, sound, light, thermal) into the body, are often delivered as components of a physical therapy intervention. This review is one in a series of reviews which form an update of the Cochrane review 'Physiotherapy interventions for shoulder pain'. OBJECTIVES: To synthesise the available evidence regarding the benefits and harms of electrotherapy modalities, delivered alone or in combination with other interventions, for the treatment of adhesive capsulitis. SEARCH METHODS: We searched CENTRAL, MEDLINE, EMBASE, CINAHL Plus and the ClinicalTrials.gov and World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) clinical trials registries up to May 2014, unrestricted by language, and reviewed the reference lists of review articles and retrieved trials to identify any other potentially relevant trials. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and controlled clinical trials using a quasi-randomised method of allocation that included adults with adhesive capsulitis and compared any electrotherapy modality to placebo, no treatment, a different electrotherapy modality, or any other intervention. The two main questions of the review focused on whether electrotherapy modalities are effective compared to placebo or no treatment, or if they are an effective adjunct to manual therapy or exercise (or both). The main outcomes of interest were participant-reported pain relief of 30% or greater, overall pain, function, global assessment of treatment success, active shoulder abduction, quality of life, and the number of participants experiencing any adverse event. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials for inclusion, extracted the data, performed a risk of bias assessment, and assessed the quality of the body of evidence for the main outcomes using the GRADE approach. MAIN RESULTS: Nineteen trials (1249 participants) were included in the review. Four trials reported using an adequate method of allocation concealment and six trials blinded participants and personnel. Only two electrotherapy modalities (low-level laser therapy (LLLT) and pulsed electromagnetic field therapy (PEMF)) have been compared to placebo. No trial has compared an electrotherapy modality plus manual therapy and exercise to manual therapy and exercise alone. The two main questions of the review were investigated in nine trials.Low quality evidence from one trial (40 participants) indicated that LLLT for six days may result in improvement at six days. Eighty per cent (16/20) of participants reported treatment success with LLLT compared with 10% (2/20) of participants receiving placebo (risk ratio (RR) 8.00, 95% confidence interval (CI) 2.11 to 30.34; absolute risk difference 70%, 95% CI 48% to 92%). No participants in either group reported adverse events.We were uncertain whether PEMF for two weeks improved pain or function more than placebo at two weeks because of the very low quality evidence from one trial (32 participants). Seventy-five per cent (15/20) of participants reported pain relief of 30% or more with PEMF compared with 0% (0/12) of participants receiving placebo (RR 19.19, 95% CI 1.25 to 294.21; absolute risk difference 75%, 95% CI 53% to 97%). Fifty-five per cent (11/20) of participants reported total recovery of joint function with PEMF compared with 0% (0/12) of participants receiving placebo (RR 14.24, 95% CI 0.91 to 221.75; absolute risk difference 55%, 95% CI 31 to 79).Moderate quality evidence from one trial (63 participants) indicated that LLLT plus exercise for eight weeks probably results in greater improvement when measured at the fourth week of treatment, but a similar number of adverse events, compared with placebo plus exercise. The mean pain score at four weeks was 51 points with placebo plus exercise, while with LLLT plus exercise the mean pain score was 32 points on a 100 point scale (mean difference (MD) 19 points, 95% CI 15 to 23; absolute risk difference 19%, 95% CI 15% to 23%). The mean function impairment score was 48 points with placebo plus exercise, while with LLLT plus exercise the mean function impairment score was 36 points on a 100 point scale (MD 12 points, 95% CI 6 to 18; absolute risk difference 12%, 95% CI 6 to 18). Mean active abduction was 70 degrees with placebo plus exercise, while with LLLT plus exercise mean active abduction was 79 degrees (MD 9 degrees, 95% CI 2 to 16; absolute risk difference 5%, 95% CI 1% to 9%). No participants in either group reported adverse events. LLLT's benefits on function were maintained at four months.Based on very low quality evidence from six trials, we were uncertain whether therapeutic ultrasound, PEMF, continuous short wave diathermy, Iodex phonophoresis, a combination of Iodex iontophoresis with continuous short wave diathermy, or a combination of therapeutic ultrasound with transcutaneous electrical nerve stimulation (TENS) were effective adjuncts to exercise. Based on low or very low quality evidence from 12 trials, we were uncertain whether a diverse range of electrotherapy modalities (delivered alone or in combination with manual therapy, exercise, or other active interventions) were more or less effective than other active interventions (for example glucocorticoid injection). AUTHORS' CONCLUSIONS: Based upon low quality evidence from one trial, LLLT for six days may be more effective than placebo in terms of global treatment success at six days. Based upon moderate quality evidence from one trial, LLLT plus exercise for eight weeks may be more effective than exercise alone in terms of pain up to four weeks, and function up to four months. It is unclear whether PEMF is more or less effective than placebo, or whether other electrotherapy modalities are an effective adjunct to exercise. Further high quality randomised controlled trials are needed to establish the benefits and harms of physical therapy interventions (that comprise electrotherapy modalities, manual therapy and exercise, and are reflective of clinical practice) compared to interventions with evidence of benefit (for example glucocorticoid injection or arthrographic joint distension).

Bias due to selective inclusion and reporting of outcomes and analyses in systematic reviews of randomised trials of healthcare interventions.

BACKGROUND: Systematic reviews may be compromised by selective inclusion and reporting of outcomes and analyses. Selective inclusion occurs when there are multiple effect estimates in a trial report that could be included in a particular meta-analysis (e.g. from multiple measurement scales and time points) and the choice of effect estimate to include in the meta-analysis is based on the results (e.g. statistical significance, magnitude or direction of effect). Selective reporting occurs when the reporting of a subset of outcomes and analyses in the systematic review is based on the results (e.g. a protocol-defined outcome is omitted from the published systematic review). OBJECTIVES: To summarise the characteristics and synthesise the results of empirical studies that have investigated the prevalence of selective inclusion or reporting in systematic reviews of randomised controlled trials (RCTs), investigated the factors (e.g. statistical significance or direction of effect) associated with the prevalence and quantified the bias. SEARCH METHODS: We searched the Cochrane Methodology Register (to July 2012), Ovid MEDLINE, Ovid EMBASE, Ovid PsycINFO and ISI Web of Science (each up to May 2013), and the US Agency for Healthcare Research and Quality (AHRQ) Effective Healthcare Program's Scientific Resource Center (SRC) Methods Library (to June 2013). We also searched the abstract books of the 2011 and 2012 Cochrane Colloquia and the article alerts for methodological work in research synthesis published from 2009 to 2011 and compiled in Research Synthesis Methods. SELECTION CRITERIA: We included both published and unpublished empirical studies that investigated the prevalence and factors associated with selective inclusion or reporting, or both, in systematic reviews of RCTs of healthcare interventions. We included empirical studies assessing any type of selective inclusion or reporting, such as investigations of how frequently RCT outcome data is selectively included in systematic reviews based on the results, outcomes and analyses are discrepant between protocol and published review or non-significant outcomes are partially reported in the full text or summary within systematic reviews. DATA COLLECTION AND ANALYSIS: Two review authors independently selected empirical studies for inclusion, extracted the data and performed a risk of bias assessment. A third review author resolved any disagreements about inclusion or exclusion of empirical studies, data extraction and risk of bias. We contacted authors of included studies for additional unpublished data. Primary outcomes included overall prevalence of selective inclusion or reporting, association between selective inclusion or reporting and the statistical significance of the effect estimate, and association between selective inclusion or reporting and the direction of the effect estimate. We combined prevalence estimates and risk ratios (RRs) using a random-effects meta-analysis model. MAIN RESULTS: Seven studies met the inclusion criteria. No studies had investigated selective inclusion of results in systematic reviews, or discrepancies in outcomes and analyses between systematic review registry entries and published systematic reviews. Based on a meta-analysis of four studies (including 485 Cochrane Reviews), 38% (95% confidence interval (CI) 23% to 54%) of systematic reviews added, omitted, upgraded or downgraded at least one outcome between the protocol and published systematic review. The association between statistical significance and discrepant outcome reporting between protocol and published systematic review was uncertain. The meta-analytic estimate suggested an increased risk of adding or upgrading (i.e. changing a secondary outcome to primary) when the outcome was statistically significant, although the 95% CI included no association and a decreased risk as plausible estimates (RR 1.43, 95% CI 0.71 to 2.85; two studies, n = 552 meta-analyses). Also, the meta-analytic estimate suggested an increased risk of downgrading (i.e. changing a primary outcome to secondary) when the outcome was statistically significant, although the 95% CI included no association and a decreased risk as plausible estimates (RR 1.26, 95% CI 0.60 to 2.62; two studies, n = 484 meta-analyses). None of the included studies had investigated whether the association between statistical significance and adding, upgrading or downgrading of outcomes was modified by the type of comparison, direction of effect or type of outcome; or whether there is an association between direction of the effect estimate and discrepant outcome reporting.Several secondary outcomes were reported in the included studies. Two studies found that reasons for discrepant outcome reporting were infrequently reported in published systematic reviews (6% in one study and 22% in the other). One study (including 62 Cochrane Reviews) found that 32% (95% CI 21% to 45%) of systematic reviews did not report all primary outcomes in the abstract. Another study (including 64 Cochrane and 118 non-Cochrane reviews) found that statistically significant primary outcomes were more likely to be completely reported in the systematic review abstract than non-significant primary outcomes (RR 2.66, 95% CI 1.81 to 3.90). None of the studies included systematic reviews published after 2009 when reporting standards for systematic reviews (Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) Statement, and Methodological Expectations of Cochrane Intervention Reviews (MECIR)) were disseminated, so the results might not be generalisable to more recent systematic reviews. AUTHORS' CONCLUSIONS: Discrepant outcome reporting between the protocol and published systematic review is fairly common, although the association between statistical significance and discrepant outcome reporting is uncertain. Complete reporting of outcomes in systematic review abstracts is associated with statistical significance of the results for those outcomes. Systematic review outcomes and analysis plans should be specified prior to seeing the results of included studies to minimise post-hoc decisions that may be based on the observed results. Modifications that occur once the review has commenced, along with their justification, should be clearly reported. Effect estimates and CIs should be reported for all systematic review outcomes regardless of the results. The lack of research on selective inclusion of results in systematic reviews needs to be addressed and studies that avoid the methodological weaknesses of existing research are also needed.

Manual therapy and exercise for adhesive capsulitis (frozen shoulder).

BACKGROUND: Adhesive capsulitis (also termed frozen shoulder) is commonly treated by manual therapy and exercise, usually delivered together as components of a physical therapy intervention. This review is one of a series of reviews that form an update of the Cochrane review, 'Physiotherapy interventions for shoulder pain.' OBJECTIVES: To synthesise available evidence regarding the benefits and harms of manual therapy and exercise, alone or in combination, for the treatment of patients with adhesive capsulitis. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CINAHL Plus, ClinicalTrials.gov and the WHO ICTRP clinical trials registries up to May 2013, unrestricted by language, and reviewed the reference lists of review articles and retrieved trials, to identify potentially relevant trials. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-randomised trials, including adults with adhesive capsulitis, and comparing any manual therapy or exercise intervention versus placebo, no intervention, a different type of manual therapy or exercise or any other intervention. Interventions included mobilisation, manipulation and supervised or home exercise, delivered alone or in combination. Trials investigating the primary or adjunct effect of a combination of manual therapy and exercise were the main comparisons of interest. Main outcomes of interest were participant-reported pain relief of 30% or greater, overall pain (mean or mean change), function, global assessment of treatment success, active shoulder abduction, quality of life and the number of participants experiencing adverse events. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials for inclusion, extracted the data, performed a risk of bias assessment and assessed the quality of the body of evidence for the main outcomes using the GRADE approach. MAIN RESULTS: We included 32 trials (1836 participants). No trial compared a combination of manual therapy and exercise versus placebo or no intervention. Seven trials compared a combination of manual therapy and exercise versus other interventions but were clinically heterogeneous, so opportunities for meta-analysis were limited. The overall impression gained from these trials is that the few outcome differences between interventions that were clinically important were detected only up to seven weeks. Evidence of moderate quality shows that a combination of manual therapy and exercise for six weeks probably results in less improvement at seven weeks but a similar number of adverse events compared with glucocorticoid injection. The mean change in pain with glucocorticoid injection was 58 points on a 100-point scale, and 32 points with manual therapy and exercise (mean difference (MD) 26 points, 95% confidence interval (CI) 15 points to 37 points; one RCT, 107 participants), for an absolute difference of 26% (15% to 37%). Mean change in function with glucocorticoid injection was 39 points on a 100-point scale, and 14 points with manual therapy and exercise (MD 25 points, 95% CI 35 points to 15 points; one RCT, 107 participants), for an absolute difference of 25% (15% to 35%). Forty-six per cent (26/56) of participants reported treatment success with manual therapy and exercise compared with 77% (40/52) of participants receiving glucocorticoid injection (risk ratio (RR) 0.6, 95% CI 0.44 to 0.83; one RCT, 108 participants), with an absolute risk difference of 30% (13% to 48%). The number reporting adverse events did not differ between groups: 56% (32/57) reported events with manual therapy and exercise, and 53% (30/57) with glucocorticoid injection (RR 1.07, 95% CI 0.76 to 1.49; one RCT, 114 participants), with an absolute risk difference of 4% (-15% to 22%). Group differences in improvement in overall pain and function at six months and 12 months were not clinically important.We are uncertain of the effect of other combinations of manual therapy and exercise, as most evidence is of low quality. Meta-analysis of two trials (86 participants) suggested no clinically important differences between a combination of manual therapy, exercise, and electrotherapy for four weeks and placebo injection compared with glucocorticoid injection alone or placebo injection alone in terms of overall pain, function, active range of motion and quality of life at six weeks, six months and 12 months (though the 95% CI suggested function may be better with glucocorticoid injection at six weeks). The same two trials found that adding a combination of manual therapy, exercise and electrotherapy for four weeks to glucocorticoid injection did not confer clinically important benefits over glucocorticoid injection alone at each time point. Based on one high quality trial (148 participants), following arthrographic joint distension with glucocorticoid and saline, a combination of manual therapy and supervised exercise for six weeks conferred similar effects to those of sham ultrasound in terms of overall pain, function and quality of life at six weeks and at six months, but provided greater patient-reported treatment success and active shoulder abduction at six weeks. One trial (119 participants) found that a combination of manual therapy, exercise, electrotherapy and oral non-steroidal anti-inflammatory drug (NSAID) for three weeks did not confer clinically important benefits over oral NSAID alone in terms of function and patient-reported treatment success at three weeks.On the basis of 25 clinically heterogeneous trials, we are uncertain of the effect of manual therapy or exercise when not delivered together, or one type of manual therapy or exercise versus another, as most reported differences between groups were not clinically or statistically significant, and the evidence is mostly of low quality. AUTHORS' CONCLUSIONS: The best available data show that a combination of manual therapy and exercise may not be as effective as glucocorticoid injection in the short-term. It is unclear whether a combination of manual therapy, exercise and electrotherapy is an effective adjunct to glucocorticoid injection or oral NSAID. Following arthrographic joint distension with glucocorticoid and saline, manual therapy and exercise may confer effects similar to those of sham ultrasound in terms of overall pain, function and quality of life, but may provide greater patient-reported treatment success and active range of motion. High-quality RCTs are needed to establish the benefits and harms of manual therapy and exercise interventions that reflect actual practice, compared with placebo, no intervention and active interventions with evidence of benefit (e.g. glucocorticoid injection).

Delivery of Allied Health Interventions Using Telehealth Modalities: A Rapid Systematic Review of Randomized Controlled Trials.

Objectives: To determine whether allied health interventions delivered using telehealth provide similar or better outcomes for patients compared with traditional face-to-face delivery modes. Study design: A rapid systematic review using the Cochrane methodology to extract eligible randomized trials. Eligible trials: Trials were eligible for inclusion if they compared a comparable dose of face-to-face to telehealth interventions delivered by a neuropsychologist, occupational therapist, physiotherapist, podiatrist, psychologist, and/or speech pathologist; reported patient-level outcomes; and included adult participants. Data sources: MEDLINE, CENTRAL, CINAHL, and EMBASE databases were first searched from inception for systematic reviews and eligible trials were extracted from these systematic reviews. These databases were then searched for randomized clinical trials published after the date of the most recent systematic review search in each discipline (2017). The reference lists of included trials were also hand-searched to identify potentially missed trials. The risk of bias was assessed using the Cochrane Risk of Bias Tool Version 1. Data Synthesis: Fifty-two trials (62 reports, n = 4470) met the inclusion criteria. Populations included adults with musculoskeletal conditions, stroke, post-traumatic stress disorder, depression, and/or pain. Synchronous and asynchronous telehealth approaches were used with varied modalities that included telephone, videoconferencing, apps, web portals, and remote monitoring, Overall, telehealth delivered similar improvements to face-to-face interventions for knee range, Health-Related Quality of Life, pain, language function, depression, anxiety, and Post-Traumatic Stress Disorder. This meta-analysis was limited for some outcomes and disciplines such as occupational therapy and speech pathology. Telehealth was safe and similar levels of satisfaction and adherence were found across modes of delivery and disciplines compared to face-to-face interventions. Conclusions: Many allied health interventions are equally as effective as face-to-face when delivered via telehealth. Incorporating telehealth into models of care may afford greater access to allied health professionals, however further comparative research is still required. In particular, significant gaps exist in our understanding of the efficacy of telehealth from podiatrists, occupational therapists, speech pathologists, and neuropsychologists. Protocol Registration Number: PROSPERO (CRD42020203128).