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Objective: High amounts of sedentary behavior increase the risk of cardiovascular disease. This study aimed to determine the preliminary effectiveness and feasibility of the RISE intervention to support community-dwelling people with stroke, who are highly sedentary, to reduce and interrupt sedentary time. Additionally, the added value of including participatory support was determined. Methods: A randomized, multiple-baseline study was conducted including 14 participants. All received the RISE intervention, a 15-week blended behavioral intervention in which a primary care physiotherapist provided personalized coaching in the home setting by using behavior-change techniques and the RISE eCoaching system, including an activity monitor and app to provide real time feedback. Half of the participants (randomly allocated) received participatory support from someone from their social network (e.g., partner or close friend) who joined them in the intervention. Preliminary effectiveness was determined with significant changes in total sedentary time and fragmentation (interruption) of sedentary time using a randomization test. Feasibility was assessed by adherence with the intervention protocol, safety, and satisfaction with the intervention. Results: Participants significantly reduced total sedentary time (p = 0.01) by 1.3 h on average and increased their fragmentation (p < 0.01). Subgroup analyses showed significant improvements in both outcomes only in the group with participatory support. Thirteen (92.9%) participants completed the intervention, no related adverse events occurred, and the reported participant satisfaction was sufficient. Conclusions: The RISE intervention appears promising to support people with stroke who are highly sedentary to reduce and interrupt their sedentary time. Participatory support appears to contribute to greater results. Trial registration: ISRCTN international trial registry, 10694741.
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BACKGROUND: In the context of expanding digital health tools, the health system is ready for Learning Health System (LHS) models. These models, with proper governance and stakeholder engagement, enable the integration of digital infrastructure to provide feedback to all relevant parties including clinicians and consumers on performance against best practice standards, as well as fostering innovation and aligning healthcare with patient needs. The LHS literature primarily includes opinion or consensus-based frameworks and lacks validation or evidence of benefit. Our aim was to outline a rigorously codesigned, evidence-based LHS framework and present a national case study of an LHS-aligned national stroke program that has delivered clinical benefit. MAIN TEXT: Current core components of a LHS involve capturing evidence from communities and stakeholders (quadrant 1), integrating evidence from research findings (quadrant 2), leveraging evidence from data and practice (quadrant 3), and generating evidence from implementation (quadrant 4) for iterative system-level improvement. The Australian Stroke program was selected as the case study as it provides an exemplar of how an iterative LHS works in practice at a national level encompassing and integrating evidence from all four LHS quadrants. Using this case study, we demonstrate how to apply evidence-based processes to healthcare improvement and embed real-world research for optimising healthcare improvement. We emphasize the transition from research as an endpoint, to research as an enabler and a solution for impact in healthcare improvement. CONCLUSIONS: The Australian Stroke program has nationally improved stroke care since 2007, showcasing the value of integrated LHS-aligned approaches for tangible impact on outcomes. This LHS case study is a practical example for other health conditions and settings to follow suit.
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Sistema de Aprendizagem em Saúde , Acidente Vascular Cerebral , Humanos , Acidente Vascular Cerebral/terapia , Austrália , Medicina Baseada em Evidências , Prática Clínica Baseada em Evidências/métodosRESUMO
OBJECTIVES: The COVID-19 pandemic necessitated rapid transition to telehealth. Telehealth presents challenges for rehabilitation of stroke survivors with moderate-to-severe physical disability, which traditionally relies on physical interactions. The objective was to co-design resources to support delivery of rehabilitation via telehealth for this cohort. DESIGN: Four-stage integrated knowledge translation co-design approach. Stage 1: Research team comprising researchers, clinicians and stroke survivors defined the research question and approach. Stage 2: Workshops and interviews were conducted with knowledge users (participants) to identify essential elements of the program. Stage 3: Resources developed by the research team. Stage 4: Resources reviewed by knowledge users and adapted. PARTICIPANTS: Twenty-one knowledge users (clinicians nâ¯=â¯11, stroke survivors nâ¯=â¯7, caregivers nâ¯=â¯3) RESULTS: All stakeholders emphasised the complexities of telehealth rehabilitation for stroke and the need for individualised programs. Shared decision-making was identified as critical. Potential risks and benefits of telehealth were acknowledged and strategies to ameliorate risks and deliver effective rehabilitation were identified. Four freely available online resources were co-designed; three resources to support clinicians with shared decision-making and risk management and a decision-aid to support stroke survivors and caregivers throughout the process. Over six months, 1129 users have viewed the webpage; clinician resources were downloaded 374 times and the decision-aid was downloaded 570 times. CONCLUSIONS: The co-design process identified key elements for delivery of telehealth rehabilitation to stroke survivors with moderate-to-severe physical disability and led to development of resources to support development of an individualised telehealth rehabilitation plan. Future research should evaluate the effectiveness of these resources. CONTRIBUTION OF PAPER.
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COVID-19 , Reabilitação do Acidente Vascular Cerebral , Telerreabilitação , Humanos , Reabilitação do Acidente Vascular Cerebral/métodos , Telerreabilitação/métodos , Feminino , Masculino , Cuidadores , Pessoa de Meia-Idade , Pessoas com Deficiência/reabilitação , SARS-CoV-2 , Telemedicina/métodos , IdosoRESUMO
PURPOSE: To identify Capabilities, Opportunities, and Motivational factors influencing movement behaviour throughout the day in people with stroke who are highly sedentary and inactive to enable intervention development. METHODS: A qualitative study was conducted using semistructured interviews with people with stroke. The interview guide was based on the Capabilities, Opportunities, and Motivation Behavioural model. RESULTS: Eleven interviews were conducted. Participants reported a lack of knowledge regarding healthy movement behaviour patterns, a lack of insight into their own movement behaviour, and some physical and cognitive limitations to engage in certain physical activities. Several social and environmental elements affecting movement behaviours were mentioned, their impact on movement behaviour varied among participants. Movement behaviour was mostly driven by habits and daily routine, without conscious regulation. CONCLUSION: Our findings show that people with stroke are unaware of their own movement behaviour or of the consequences of these behaviours on health. Movement behaviour is, for the most part, based on daily routine and personal habits. This indicates the need for a behaviour change intervention. Such interventions will need to include providing information about healthy movement behaviour, feedback on individual's movement behaviour and individualized support, taking into account the social and environmental context and personal capabilities.
There is a need to provide insight and feedback regarding individuals' movement behaviour and information about healthy movement behaviour to enable people with stroke who are highly sedentary and inactive to improve their movement behaviour.Movement behaviour is, for the most part, based on daily routine and personal habits.People need individualised support, and personal capabilities, the social and environmental context need to be taken into account to support sustainable movement behaviour change.These findings can be used in clinical practise and to inform intervention development to support movement behaviour change in people after stroke who are highly sedentary and inactive.
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People with neurological conditions may face barriers to meal preparation. Culinary nutrition interventions aim to facilitate the building of knowledge and skills for meal preparation. This scoping review aims to map the available evidence for culinary nutrition interventions for people with neurological conditions and evaluate the quality of these interventions based on program design, delivery and evaluation. After a systematic search of online databases (MEDLINE, CINAHL, Embase, Scopus and Proquest) and reference lists, a total of ten publications describing nine interventions were included. Most interventions were designed for people with stroke and/or Transient Ischemic Attack (n = 3) and Multiple Sclerosis (n = 3); others were for traumatic brain injury (n = 1), mild dementia (n = 1) and Parkinson's Disease (n = 1). Overall, the included culinary nutrition interventions had good program delivery (inclusion of motivational experiences, delivered by appropriate health providers) but needed improvements in program design (lack of consumer engagement and neurological symptom accommodations) and evaluation (lack of complete process, outcome and impact evaluations). In conclusion, the evidence base for culinary nutrition interventions for people with neurological conditions remains sparse. To bridge the gap between theory and practice, it is important to consider the following aspects in culinary nutrition intervention planning/improvement: (I) the involvement of consumers; (II) the accommodation/tailoring for post-condition effects; and (III) the coverage of all disease-specific culinary nutrition aspects.
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Doenças do Sistema Nervoso , Humanos , Doenças do Sistema Nervoso/dietoterapia , Doenças do Sistema Nervoso/terapia , Culinária , RefeiçõesRESUMO
ISSUES ADDRESSED: To (i) determine the prevalence of health risk factors (physical activity, diet, alcohol, smoking, blood pressure medication use and mental health) in community-dwelling stroke survivors; and (ii) examine how these health risk factors cluster, and identify associations with physical functioning, independent living, or sociodemographic factors. METHODS: A secondary analysis of data obtained during a national randomised controlled trial. Participants had experienced stroke and completed a baseline telephone survey on demographic and stroke characteristics, health risk factors, physical functioning and independence in activities of daily living. A latent class analysis was performed to determine health risk profiles. Univariate logistic regressions were performed to identify if participant characteristics were associated with resulting classes. RESULTS: Data analysed from 399 participants. Two classes of health risk factors were identified: Low Mood, Food & Moves Risk (16% of participants) and Alcohol Use Risk (84% of participants). The Low Mood, Food & Moves Risk group had poorer diet quality, lower physical activity levels and higher levels of depression and anxiety. Lower levels of independence and physical functioning were predictor variables for this group. In contrast, the Alcohol Use Risk group had better physical activity and diet scores, significantly lower probability of depression and anxiety, but a higher probability of risky drinking. CONCLUSIONS: We identified two distinct health risk factor groups in our population. SO WHAT?: Future interventions may benefit from targeting the specific needs and requirements of people who have experienced stroke based on their distinct risk group. Alcohol consumption in poststroke populations requires further attention.
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Atividades Cotidianas , Acidente Vascular Cerebral , Humanos , Análise de Classes Latentes , Austrália , Fatores de Risco , Acidente Vascular Cerebral/psicologia , SobreviventesRESUMO
RATIONALE: Fatigue affects almost half of all people living with stroke. Stroke survivors rank understanding fatigue and how to reduce it as one of the highest research priorities. METHODS: We convened an interdisciplinary, international group of clinical and pre-clinical researchers and lived experience experts. We identified four priority areas: (1) best measurement tools for research, (2) clinical identification of fatigue and potentially modifiable causes, (3) promising interventions and recommendations for future trials, and (4) possible biological mechanisms of fatigue. Cross-cutting themes were aphasia and the voice of people with lived experience. Working parties were formed and structured consensus building processes were followed. RESULTS: We present 20 recommendations covering outcome measures for research, development, and testing of new interventions and priority areas for future research on the biology of post-stroke fatigue. We developed and recommend the use of the Stroke Fatigue Clinical Assessment Tool. CONCLUSIONS: By synthesizing current knowledge in post-stroke fatigue across clinical and pre-clinical fields, our work provides a roadmap for future research into post-stroke fatigue.
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Reabilitação do Acidente Vascular Cerebral , Acidente Vascular Cerebral , Humanos , Acidente Vascular Cerebral/complicações , Acidente Vascular Cerebral/terapia , Consenso , Pesquisa de Reabilitação , Fadiga/etiologia , Fadiga/terapiaRESUMO
RATIONALE: Fatigue affects almost half of all people living with stroke. Stroke survivors rank understanding fatigue and how to reduce it as one of the highest research priorities. METHODS: We convened an interdisciplinary, international group of clinical and pre-clinical researchers and lived experience experts. We identified four priority areas: (1) best measurement tools for research, (2) clinical identification of fatigue and potentially modifiable causes, (3) promising interventions and recommendations for future trials, and (4) possible biological mechanisms of fatigue. Cross-cutting themes were aphasia and the voice of people with lived experience. Working parties were formed and structured consensus building processes were followed. RESULTS: We present 20 recommendations covering outcome measures for research, development, and testing of new interventions and priority areas for future research on the biology of post-stroke fatigue. We developed and recommend the use of the Stroke Fatigue Clinical Assessment Tool. CONCLUSIONS: By synthesizing current knowledge in post-stroke fatigue across clinical and pre-clinical fields, our work provides a roadmap for future research into post-stroke fatigue.
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Reabilitação do Acidente Vascular Cerebral , Acidente Vascular Cerebral , Humanos , Consenso , Acidente Vascular Cerebral/complicações , Pesquisa de Reabilitação , Fadiga/etiologia , Fadiga/terapiaRESUMO
BACKGROUND: Improving physical activity levels and diet quality are important for secondary stroke prevention. AIM: To test the feasibility and safety of 6-month, co-designed telehealth-delivered interventions to increase physical activity and improve diet quality. METHODS: A 2 × 2 factorial trial (physical activity (PA); diet (DIET); PA + DIET; control) randomized, open-label, blinded endpoint trial. Primary outcomes were feasibility and safety. Secondary outcomes included stroke risk factors (blood pressure, self-report PA (International Physical Activity Questionnaire (IPAQ)) and diet quality (Australian Recommended Food Score (ARFS)), and quality of life. Between-group differences were analyzed using linear-mixed models. RESULTS: Over 23 months, 99 people were screened for participation and 40 (40%) randomized (3 months to 10 years post-stroke, mean age 59 (16) years). Six participants withdrew, and an additional five were lost to follow-up. Fifteen serious adverse events were reported, but none were deemed definitely or probably related to the intervention. Median attendance was 32 (of 36) PA sessions and 9 (of 10) DIET sessions. The proportion of missing primary outcome data (blood pressure) was 3% at 3 months, 11% at 6 months, and 14% at 12 months. Between-group 95% confidence intervals showed promising, clinically relevant differences in support of the interventions across the range of PA, diet quality, and blood pressure outcomes. CONCLUSION: Our telehealth PA and diet interventions were safe and feasible and may have led to significant behavior change. TRIAL REGISTRATION: ACTRN12620000189921.
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Acidente Vascular Cerebral , Telemedicina , Humanos , Pessoa de Meia-Idade , Austrália , Dieta , Exercício Físico , Projetos Piloto , Qualidade de Vida , Prevenção Secundária , Acidente Vascular Cerebral/prevenção & controle , Adulto , IdosoRESUMO
INTRODUCTION: Diet quality is a marker of how closely eating patterns reflect dietary guidelines. The highest tertile for diet quality scores is associated with 40% lower odds of first stroke compared with the lowest tertile. Little is known about the diet of stroke survivors. We aimed to assess dietary intake and quality of Australian stroke survivors. METHODS: Stroke survivors enrolled in the ENAbLE pilot trial (2019/ETH11533, ACTRN12620000189921) and Food Choices after Stroke study (2020ETH/02264) completed the Australian Eating Survey Food Frequency Questionnaire (AES), a 120-item, semiquantitative questionnaire of habitual food intake over the previous 3-6 months. Diet quality was determined by calculating the Australian Recommended Food Score (ARFS): a higher score indicates higher diet quality. RESULTS: Eighty-nine adult, stroke survivors (female: n = 45, 51%) of mean age 59.5 years (±9.9) had a mean ARFS of 30.5 (±9.9) (low diet quality). Mean energy intake was similar to the Australian population: 34.1% from noncore (energy-dense/nutrient-poor) and 65.9% from core (healthy) foods. However, participants in the lowest tertile for diet quality (n = 31) had significantly lower intake of core (60.0%) and higher intake from noncore foods (40.0%). Most participants did not meet daily requirements for fiber, potassium, or omega 3 fatty acids (2%, 15%, and 18%), nutrients important to reduce stroke risk. CONCLUSION: The diet quality of stroke survivors was poor, with inadequate intake of nutrients important for reducing recurrent stroke risk. Further research is needed to develop effective interventions to improve diet quality.
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Dieta , Acidente Vascular Cerebral , Adulto , Feminino , Humanos , Pessoa de Meia-Idade , Austrália , Dieta/efeitos adversos , Ingestão de Energia , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/terapia , Sobreviventes , Masculino , IdosoRESUMO
BACKGROUND: Post-stroke fatigue (PSF) is a significant and highly prevalent symptom, whose mechanisms are poorly understood. The third Stroke Recovery and Rehabilitation Roundtable paper on PSF focussed primarily on defining and measuring PSF while mechanisms were briefly discussed. This companion paper to the main paper is aimed at elaborating possible mechanisms of PSF. METHODS: This paper reviews the available evidence that potentially explains the pathophysiology of PSF and draws parallels from fatigue literature in other conditions. We start by proposing a case for phenotyping PSF based on structural, functional, and behavioral characteristics of PSF. This is followed by discussion of a potentially significant role of early inflammation in the development of fatigue, specifically the impact of low-grade inflammation and its long-term systemic effects resulting in PSF. Of the many neurotransmitter systems in the brain, the dopaminergic systems have the most evidence for a role in PSF, along with a role in sensorimotor processing. Sensorimotor neural network dynamics are compromised as highlighted by evidence from both neurostimulation and neuromodulation studies. The double-edged sword effect of exercise on PSF provides further insight into how PSF might emerge and the importance of carefully titrating interventional paradigms. CONCLUSION: The paper concludes by synthesizing the presented evidence into a unifying model of fatigue which distinguishes between factors that pre-dispose, precipitate, and perpetuate PSF. This framework will help guide new research into the biological mechanisms of PSF which is a necessary prerequisite for developing treatments to mitigate the debilitating effects of post-stroke fatigue.
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Reabilitação do Acidente Vascular Cerebral , Acidente Vascular Cerebral , Humanos , Seguimentos , Depressão/diagnóstico , Acidente Vascular Cerebral/complicações , Inflamação , FadigaRESUMO
BACKGROUND: Adults with chronic health conditions need support to manage modifiable risk factors such as physical inactivity and poor diet. Disease-specific websites with health information on physical activity and diet quality may be effective in supporting adults in managing their chronic illnesses. OBJECTIVE: The primary aim of this review was to determine whether using websites with health information can lead to improvements in physical activity levels or diet quality in adults with chronic health conditions. METHODS: Randomized controlled trials evaluating the effectiveness of website use on levels of physical activity or diet quality in adults with chronic health conditions were included. MEDLINE, Embase, CINAHL, and the Physiotherapy Evidence Database were searched from the earliest available record until February 2023. Data for outcomes measuring physical activity levels; diet quality; and, where reported, self-efficacy and quality of life were independently extracted by 2 reviewers. The risk of bias was assessed using the Physiotherapy Evidence Database scale, and the overall certainty of evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation approach. Where values were presented as the same unit of measure, postintervention scores were pooled for meta-analysis to yield an overall mean difference (MD). A standardized MD (SMD) was calculated for the pooled data in which different units for the same outcome were used. Individual trial data were described in cases where the data of trials could not be pooled. RESULTS: A total of 29 trials (N=6418 participants) across 8 different disease groups with intervention periods ranging from 4 weeks to 12 months were included in the analysis. There was moderate-certainty evidence that using websites with health information increased levels of moderate to vigorous physical activity (MD=39 min/wk, 95% CI 18.60-58.47), quality of life (SMD=0.36, 95% CI 0.12-0.59), and self-efficacy (SMD=0.26, 95% CI 0.05-0.48) and high-certainty evidence for reduction in processed meat consumption (MD=1.1 portions/wk, 95% CI 0.70-1.58) when compared with usual care. No differences were detected in other measures of diet quality. There was no increased benefit for website users who were offered additional support. CONCLUSIONS: The use of websites for risk factor management has the potential to improve physical activity levels, quality of life, and self-efficacy as well as reduce processed meat consumption for adults living with chronic health conditions when compared with usual care. However, it remains unclear whether using websites leads to meaningful and long-lasting behavior change. TRIAL REGISTRATION: PROSPERO CRD42021283168; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=283168.
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Dieta , Qualidade de Vida , Adulto , Humanos , Doença Crônica , Exercício FísicoRESUMO
Secondary prevention is a major priority for those living with stroke and may be improved through the use of mobile Health (mHealth) interventions. While evidence for the effectiveness of mHealth interventions for secondary prevention of stroke is growing, little attention has been given to the translation of these interventions into real-world use. In this review, we aimed to provide an update on the effectiveness of mHealth interventions for secondary prevention of stroke, and investigate their translation into real-world use. Four electronic databases and the gray literature were searched for randomized controlled trials of mHealth interventions for secondary prevention of stroke published between 2010 and 2023. Qualitative and mixed-methods evaluations of the trials were also included. Data were extracted regarding study design, population, mHealth technology involved, the intervention, and outcomes. Principal researchers from these trials were also contacted to obtain further translational information. From 1151 records, 13 randomized controlled trials and 4 evaluations were identified; sample sizes varied widely (median, 56; range, 24-4298). Short message service messages (9/13) and smartphone applications (6/13) were the main technologies used to deliver interventions. Primary outcomes of feasibility of the intervention were achieved in 4 trials, and primary outcomes of changes in risk factors, lifestyle behaviors, and adherence to medication improved in 6 trials. Only 1 trial had a hard end point (ie, stroke recurrence) as a primary outcome, and no significant differences were observed between groups. There was evidence for only 1 intervention being successfully translated into real-world use. Further evidence is required on the clinical effectiveness of mHealth interventions for preventing recurrent stroke, and the associated delivery costs and cost-effectiveness, before adoption into real-world settings.
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Acidente Vascular Cerebral , Telemedicina , Envio de Mensagens de Texto , Humanos , Prevenção Secundária , Telemedicina/métodos , Acidente Vascular Cerebral/prevenção & controle , PolíticasRESUMO
PURPOSE: Post-stroke fatigue is a research priority for stroke survivors and health professionals but there is limited evidence to guide management. We aimed to explore (1) the experience of post-stroke fatigue from the perspective of stroke survivors and their caregivers and (2) fatigue management strategies that are used. MATERIALS AND METHODS: This was a qualitative study using semi-structured interviews. People with self-reported post-stroke fatigue and caregivers were recruited using maximum variation sampling. Analysis was done via the framework approach. RESULTS: We recruited 17 stroke survivors, nine male (53%), most under 65 years (n = 12, 76%), and greater than 1-year post-stroke (n = 16, 94%, range 10-months to 22-years). One-third of participants self-reported having aphasia (n = 5, 36%). We also recruited eight caregivers, most of whom were female (n = 7, 88%). We identified four themes: (1) fatigue is unexpected after stroke and symptoms vary; (2) the individual experience of fatigue is complex, influenced by multifactorial and biopsychosocial factors; (3) learning to adapt and accept fatigue; and (4) Strategies to manage fatigue and personal approaches to rest. CONCLUSIONS: Post-stroke fatigue experience varies presenting cognitively, physically, and psychologically according to a complex interplay of biopsychosocial factors and personal triggers. Self-management strategies are individualised and include organisation, medications, lifestyle modifications, and peer support.Implications for rehabilitationPost-stroke fatigue is a complex individual experience involving biopsychosocial factors, and stroke survivors need assistance to identify their triggers and support from family, peers, and the stroke community to live well with fatigue.Fatigue is not commonly discussed by health professionals and stroke survivors need simple, practical advice over the long-term to reduce fear and distress.There are a range of strategies that may be helpful. Stroke survivors may benefit from adopting problem-solving approaches, trial pacing, lifestyle modifications and planning, and find forms of rest that work for them.
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INTRODUCTION: Stroke survivors spend long periods of time engaging in sedentary behaviour (SB) even when their functional recovery is good. In the RECREATE programme, an intervention aimed at reducing SB ('Get Set Go') will be implemented and evaluated in a pragmatic external pilot cluster randomised controlled trial with embedded process and economic evaluations. We report the protocol for the process evaluation which will address the following objectives: (1) describe and clarify causal assumptions about the intervention, and its mechanisms of impact; (2) assess implementation fidelity; (3) explore views, perceptions and acceptability of the intervention to staff, stroke survivors and their carers; (4) establish the contextual factors that influence implementation, intervention mechanisms and outcomes. METHODS AND ANALYSIS: This pilot trial will be conducted in 15 UK-based National Health Service stroke services. This process evaluation study, underpinned by the Medical Research Council guidance, will be undertaken in six of the randomised services (four intervention, two control). Data collection includes the following: observations of staff training sessions, non-participant observations in inpatient and community settings, semi-structured interviews with staff, patients and carers, and documentary analysis of key intervention components. Additional quantitative implementation data will be collected in all sites. Training observations and documentary analysis data will be summarised, with other observational and interview data analysed using thematic analysis. Relevant theories will be used to interpret the findings, including the theoretical domains framework, normalisation process theory and the theoretical framework of acceptability. Anticipated outputs include the following: recommendations for intervention refinements (both content and implementation); a revised implementation plan and a refined logic model. ETHICS AND DISSEMINATION: The study was approved by Yorkshire & The Humber - Bradford Leeds Research Ethics Committee (REC reference: 19/YH/0403). Findings will be disseminated via peer review publications, and national and international conference presentations. TRIAL REGISTRATION NUMBER: ISRCTN82280581.
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Comportamento Sedentário , Acidente Vascular Cerebral , Humanos , Medicina Estatal , Técnicas de Observação do Comportamento , Análise Custo-Benefício , Acidente Vascular Cerebral/terapia , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
INTRODUCTION: Sedentary behaviour (sitting or lying during waking hours without being otherwise active) is strongly associated with adverse health outcomes, including all-cause, cancer and cardiovascular mortality in adults. Stroke survivors are consistently reported as being more sedentary than healthy age-matched controls, spending more hours sedentary daily and sustaining longer unbroken bouts of sedentary time. An evidence-based and clinically feasible intervention ('Get Set Go') was developed. A pragmatic definitive trial to evaluate Get Set Go was planned; however, due to the unprecedented effects of the COVID-19 pandemic on National Health Service (NHS) services this study was reduced in size and scope to become an external pilot trial. We report the protocol for this external pilot trial, which aims to undertake a preliminary exploration of whether Get Set Go is likely to improve ability to complete extended activities of daily living in the first year post-stroke and inform future trial designs in stroke rehabilitation. METHODS AND ANALYSIS: This study is a pragmatic, multicentre, two-arm, external pilot cluster randomised controlled trial with embedded process and economic evaluations. UK-based stroke services will be randomised 1:1 to the intervention (usual care plus Get Set Go) or control (usual care) arm. Fifteen stroke services will recruit 300-400 stroke inpatient and carer participants, with follow-up at 6, 12 and 24 months. The proposed primary endpoint is stroke survivor self-reported Nottingham Extended Activities of Daily Living scale at 12 months. Endpoint analyses will be exploratory and provide preliminary estimates of intervention effect. The process evaluation will provide valuable information on intervention fidelity, acceptability and how it can be optimised. ETHICS AND DISSEMINATION: The study has been approved by Yorkshire and The Humber - Bradford-Leeds Research Ethics Committee (Ref: 19/YH/0403). Results will be disseminated through journal publications and conference presentations. TRIAL REGISTRATION NUMBER: This trial was registered prospectively on 01 April 2020 (ISRCTN ref: ISRCTN82280581).
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COVID-19 , Acidente Vascular Cerebral , Adulto , Humanos , Comportamento Sedentário , Atividades Cotidianas , Análise Custo-Benefício , Medicina Estatal , Pandemias , Qualidade de Vida , COVID-19/complicações , Acidente Vascular Cerebral/complicações , Sobreviventes , Reino Unido , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Multicêntricos como AssuntoRESUMO
BACKGROUND: Physical activity is important for secondary stroke prevention. Currently, there is inconsistency of outcomes and tools used to measure physical activity following stroke. AIM: To establish internationally agreed recommendations to enable consistent measurement of post-stroke physical activity. METHODS: Stroke survivors and carers were surveyed online once regarding what is important in physical activity measurement. Three survey rounds with expert stroke researchers and clinicians were conducted using Keeney's Value-Focused Thinking Methodology. Survey 1 identified physical activity tools, outcomes, and measurement considerations which were ranked in Survey 2. Consensus recommendations on tools were then formulated by the consensus group based on survey responses. In Survey 3, participants reviewed ranked results and evidence gathered to determine their support for consensus recommendations. RESULTS: Twenty-five stroke survivors, 5 carers, 18 researchers, and 17 clinicians from 16 countries participated. Time in moderate-vigorous physical activity and step count were identified as the most important outcomes to measure. Key measurement considerations included the ability to measure across frequency, intensity, duration domains in real-world settings; user-friendliness, comfort, and ability to detect changes. Consensus recommendations included using the Actigraph, Actical, and Activ8 devices for physical activity intensity; ActivPAL for duration and Step Activity Monitor for frequency; and the IPAQ and PASE questionnaires. Survey 3 indicated 100% support for device and 96% for questionnaire recommendations. CONCLUSIONS: These consensus recommendations can guide selection of physical activity measurement tools and outcomes. Tool selection will depend on measurement purpose, user-knowledge, and resources. Comprehensive measurement requires the use of devices and questionnaires.
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Acidente Vascular Cerebral , Humanos , Acidente Vascular Cerebral/terapia , Consenso , Exercício Físico/fisiologia , Inquéritos e Questionários , CuidadoresRESUMO
QUESTION: Is it feasible and safe to conduct an exercise dose-finding study in people with stroke? Is it possible to determine a minimal dose of exercise required to see clinically meaningful improvements in cardiorespiratory fitness? METHODS: Dose-escalation study. Twenty people with stroke (n=5 per cohort) who were able to walk independently participated in home-based, telehealth-supervised aerobic exercise sessions 3 d/week at moderate-vigorous intensity for 8 weeks. Dose parameters of frequency (3 d/week), intensity (55-85% of heart rate peak) and program length (8 weeks) were kept constant. The duration of exercise sessions was increased by 5 min per session from Dose 1 (10 min/session) to Dose 4 (25 min/session). Doses were escalated if safe and tolerable (< 33% of a cohort reaching a dose-limiting threshold). Doses were efficacious if ≥ 67% of a cohort increased peak oxygen consumption ≥ 2mL/kg/min. RESULTS: Target exercise doses were well adhered to, and the intervention was safe (480 exercise sessions delivered; one fall resulting in minor laceration) and tolerable (no participants met the dose-limiting threshold). None of the exercise doses met our criterion for efficacy. CONCLUSIONS: It is possible to conduct a dose-escalation trial for people with stroke. The small cohort sizes may have limited the ability to determine an efficacious minimum dose of exercise. Providing supervised exercise session at these prescribed doses via telehealth was safe. REGISTRATION: The study was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12617000460303).