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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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Accidente Cerebrovascular , Telemedicina , Humanos , Persona de Mediana Edad , Australia , Dieta , Ejercicio Físico , Proyectos Piloto , Calidad de Vida , Prevención Secundaria , Accidente Cerebrovascular/prevención & control , Adulto , AncianoRESUMEN
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 , Accidente Cerebrovascular , Adulto , Femenino , Humanos , Persona de Mediana Edad , Australia , Dieta/efectos adversos , Ingestión de Energía , Accidente Cerebrovascular/diagnóstico , Accidente Cerebrovascular/terapia , Sobrevivientes , Masculino , AncianoRESUMEN
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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Background: Sixty percent of people have non-functional arms 6 months after stroke. More effective treatments are needed. Cochrane Reviews show low-quality evidence that task-specific training improves upper limb function. Our feasibility trial showed 56 h of task-specific training over 6 weeks resulted in an increase of a median 6 points on the Action Research Arm test (ARAT), demonstrating the need for more definitive evidence from a larger randomised controlled trial. Task-AT Home is a two-arm, assessor-blinded, multicentre randomised, controlled study, conducted in the home setting. Aim: The objective is to determine whether task-specific training is a more effective treatment than usual care, for improving upper limb function, amount of upper limb use, and health related quality of life at 6 weeks and 6 months after intervention commencement. Our primary hypothesis is that upper limb function will achieve a ≥ 5 point improvement on the ARAT in the task-specific training group compared to the usual care group, after 6 weeks of intervention. Methods: Participants living at home, with remaining upper limb deficit, are recruited at 3 months after stroke from sites in NSW and Victoria, Australia. Following baseline assessment, participants are randomised to 6 weeks of either task-specific or usual care intervention, stratified for upper limb function based on the ARAT score. The task-specific group receive 14 h of therapist-led task-specific training plus 42 h of guided self-practice. The primary outcome measure is the ARAT at 6 weeks. Secondary measures include the Motor Activity Log (MAL) at 6 weeks and the ARAT, MAL and EQ5D-5 L at 6 months. Assessments occur at baseline, after 6 weeks of intervention, and at 6 months after intervention commencement. Analysis will be intention to treat using a generalised linear mixed model to report estimated mean differences in scores between the two groups at each timepoint with 95% confidence interval and value of p. Discussion: If the task-specific home-based training programme is more effective than usual care in improving arm function, implementation of the programme into clinical practice would potentially lead to improvements in upper limb function and quality of life for people with stroke. Clinical Trial Registration: ANZCTR.org.au/ACTRN12617001631392p.aspx.
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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).
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Rehabilitación de Accidente Cerebrovascular , Accidente Cerebrovascular , Humanos , Estudios de Factibilidad , Australia , Accidente Cerebrovascular/diagnóstico , Accidente Cerebrovascular/terapia , Ejercicio Físico , Rehabilitación de Accidente Cerebrovascular/efectos adversos , Terapia por Ejercicio/efectos adversosRESUMEN
PURPOSE: Evidence for post-stroke fatigue management is limited. We aimed to explore how Australian health professionals assess and assist fatigue management. Our objectives were to identify fatigue assessment tools and interventions used, explore clinician's confidence managing fatigue and explore whether management of post-stroke fatigue differs from management of fatigue related to other conditions. MATERIALS AND METHODS: An online cross-sectional survey was completed by Australian health professionals (n = 60) providing services to people with fatigue. Analysis of open-ended questions identified common interventions and descriptive statistics were calculated for closed and dichotomized questions. RESULTS: Routine use of formal fatigue assessment tools was low (17%, n = 10). Most respondents reporting use of the Fatigue Impact Scale, Fatigue Assessment Scale and Fatigue Severity Scale. To address fatigue, respondents reported providing energy optimization strategies, education, and exercise interventions in clinical practice. Less frequently reported interventions were strategies to adapt tasks, sleep hygiene, psychology, nutrition, and pharmacology interventions. Respondents were "moderately" confident managing post-stroke fatigue. Respondents did not report differences between how they manage post-stroke fatigue and fatigue present in other conditions. CONCLUSIONS: Few Australian health professionals formally assess post-stroke fatigue. Management is multidisciplinary and based on evidence from fatigue management in other conditions.Implications for rehabilitationMost health professionals are not routinely using formal assessment tools for fatigue, possibly due to a lack of consensus on best practice in research.Common strategies recommended by health professionals include energy optimisation strategies, education and exercise.Comprehensive guidelines for post-stroke fatigue management are yet to be established.Health professionals should assess post-stroke fatigue using a validated tool to ensure an individualised approach to management based on the current available clinical guidelines.
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Personal de Salud , Accidente Cerebrovascular , Humanos , Australia , Estudios Transversales , Encuestas y Cuestionarios , Accidente Cerebrovascular/complicaciones , Fatiga/etiología , Fatiga/terapiaRESUMEN
BACKGROUND: Careful development of interventions using principles of co-production is now recognized as an important step for clinical trial development, but practical guidance on how to do this in practice is lacking. This paper aims (1) provide practical guidance for researchers to co-produce interventions ready for clinical trial by describing the 4-stage process we followed, the challenges experienced and practical tips for researchers wanting to co-produce an intervention for a clinical trial; (2) describe, as an exemplar, the development of our intervention package. METHOD: We used an Integrated Knowledge Translation (IKT) approach to co-produce a telehealth-delivered exercise program for people with stroke. The 4-stage process comprised of (1) a start-up planning phase with the co-production team. (2) Content development with knowledge user informants. (3) Design of an intervention protocol. (4) Protocol refinement. RESULTS AND REFLECTIONS: The four stages of intervention development involved an 11-member co-production team and 32 knowledge user informants. Challenges faced included balancing conflicting demands of different knowledge user informant groups, achieving shared power and collaborative decision making, and optimising knowledge user input. Components incorporated into the telehealth-delivered exercise program through working with knowledge user informants included: increased training for intervention therapists; increased options to tailor the intervention to participant's needs and preferences; and re-naming of the program. Key practical tips include ways to minimise the power differential between researchers and consumers, and ensure adequate preparation of the co-production team. CONCLUSION: Careful planning and a structured process can facilitate co-production of complex interventions ready for clinical trial.
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Accidente Cerebrovascular , Telemedicina , Atención a la Salud , Terapia por Ejercicio , Humanos , Accidente Cerebrovascular/terapia , Ciencia Traslacional BiomédicaRESUMEN
BACKGROUND: Increasing physical activity (PA) and improving diet quality are opportunities to improve secondary stroke prevention, but access to appropriate services is limited. Interventions co-designed with stroke survivors and delivered by telehealth are a potential solution. AIM: The aim of this study is to test the feasibility, safety, and potential efficacy of a 6-month, telehealth-delivered PA and/or dietary (DIET) intervention. METHODS: Pilot randomized trial. 80 adults with previous stroke who are living at home with Internet access and able to exercise will be randomized in a 2 × 2 factorial (4-arm) pilot randomized, open-label, blinded outcome assessment trial to receive PA, DIET, PA + DIET, or control interventions via telehealth. The PA intervention aims to support participants to meet the minimum recommended levels of PA (150 min/week moderate exercise), and the DIET intervention aims to support participants to follow the AusMed (Mediterranean-style) diet. The control group receives usual care plus education about PA and healthy eating. The co-primary outcomes are feasibility (proportion and characteristics of eligible participants enrolled and proportion of scheduled intervention sessions attended) and safety (adverse events) at 6 months. The secondary outcomes include recurrent stroke risk factors (blood pressure, physical activity levels, and diet quality), fatigue, mood, and quality of life. Outcomes are measured at 3, 6, and 12 months. CONCLUSION: This trial will produce evidence for the feasibility, safety, and potential effect of telehealth-delivered PA and DIET interventions for people with stroke. Results will inform development of an appropriately powered trial to test effectiveness to reduce major risk factors for recurrent stroke. TRIAL REGISTRATION: ACTRN12620000189921.
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Dieta Saludable , Dieta Mediterránea , Ejercicio Físico , Conducta de Reducción del Riesgo , Prevención Secundaria , Accidente Cerebrovascular/prevención & control , Telemedicina , Estudios de Factibilidad , Conductas Relacionadas con la Salud , Conocimientos, Actitudes y Práctica en Salud , Humanos , Nueva Gales del Sur , Valor Nutritivo , Proyectos Piloto , Estudios Prospectivos , Ensayos Clínicos Controlados Aleatorios como Asunto , Recurrencia , Accidente Cerebrovascular/diagnóstico , Accidente Cerebrovascular/fisiopatología , Accidente Cerebrovascular/psicología , Factores de Tiempo , Resultado del TratamientoRESUMEN
Lifestyle interventions to reduce second stroke risk are complex. For effective translation into practice, interventions must be specific to end-user needs and described in detail for replication. This study used an Integrated Knowledge Translation (IKT) approach and the Template for Intervention Description and Replication (TIDieR) checklist to co-design and describe a telehealth-delivered diet program for stroke survivors. Stroke survivors and carers (n = 6), specialist dietitians (n = 6) and an IKT research team (n = 8) participated in a 4-phase co-design process. Phase 1: the IKT team developed the research questions, and identified essential program elements and workshop strategies for effective co-design. Phase 2: Participant co-design workshops used persona and journey mapping to create user profiles to identify barriers and essential program elements. Phase 3: The IKT team mapped Phase 2 data to the TIDieR checklist and developed the intervention prototype. Phase 4: Co-design workshops were conducted to refine the prototype for trial. Rigorous IKT co-design fundamentally influenced intervention development. Modifications to the protocol based on participant input included ensuring that all resources were accessible to people with aphasia, an additional support framework and resources specific to outcome of stroke. The feasibility and safety of this intervention is currently being pilot tested (randomised controlled trial; 2019/ETH11533, ACTRN12620000189921).
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Dieta Mediterránea , Proyectos de Investigación , Rehabilitación de Accidente Cerebrovascular/métodos , Telemedicina/métodos , Humanos , Investigación Biomédica TraslacionalRESUMEN
While neuro-recovery is maximized through active engagement, it has been suggested that the use of robotic exoskeletons in neuro-rehabilitation provides passive therapy. Using oxygen consumption (VO2) as an indicator of energy expenditure, we investigated the metabolic requirements of completing exercises in a free-standing robotic exoskeleton, with 20 healthy and 12 neurologically impaired participants (six with stroke, and six with multiple sclerosis (MS)). Neurological participants were evaluated pre- and post- 12 weeks of twice weekly robotic therapy. Healthy participants were evaluated in, and out of, the exoskeleton. Both groups increased their VO2 level from baseline during exoskeleton-assisted exercise (Healthy: mean change in VO2 = 2.10 ± 1.61 ml/kg/min, p =< 0.001; Neurological: 1.38 ± 1.22, p = 0.002), with a lower predicted mean in the neurological sample (-1.08, 95%CI -2.02, -0.14, p = 0.02). Healthy participants exercised harder out of the exoskeleton than in it (difference in VO2 = 3.50, 95%CI 2.62, 4.38, p =< 0.001). There was no difference in neurological participants' predicted mean VO2 pre- and post- 12 weeks of robotic therapy 0.45, 95%CI -0.20, 1.11, p = 0.15), although subgroup analysis revealed a greater change after 12 weeks of robotic therapy in those with stroke (MS: -0.06, 95%CI -0.78, 0.66, p = 0.85; stroke: 1.00, 95%CI 0.3, 1.69, p = 0.01; difference = 1.06, p = 0.04). Exercise in a free-standing robotic exoskeleton is not passive in healthy or neurologically impaired people, and those with stroke may derive more benefit than those with MS.
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Dispositivo Exoesqueleto , Robótica , Accidente Cerebrovascular , Terapia por Ejercicio , Humanos , Consumo de OxígenoRESUMEN
BACKGROUND: Exercise after stroke improves cardiorespiratory fitness and walking capacity; however, the effect of altering exercise dose (via frequency, intensity, time, and type) on fitness or walking capacity is unclear. PURPOSE: The purpose of this study was to synthesize the current evidence for the effects of different doses of exercise on cardiorespiratory fitness and walking capacity in people after stroke. DATA SOURCES: Seven relevant electronic databases were searched using keywords relating to stroke and cardiorespiratory fitness. STUDY SELECTION: Trials that compared more than 1 dose of exercise for people (≥ 18 years old) after stroke and measured peak oxygen consumption or 6-minute walk test distance as an outcome were included. Two reviewers independently appraised all trials. DATA EXTRACTION: Two reviewers independently extracted data from included articles. Intervention variables were extracted in accordance with the Template for Intervention Description and Replication checklist. DATA SYNTHESIS: Data were synthesized narratively. Nine trials involving 279 participants were included. Three of 5 trials comparing exercise intensity showed that higher-intensity training was associated with greater improvements in cardiorespiratory fitness. The effects of other exercise dose components (frequency, time, and type) on fitness were not determined. Overall, walking capacity improved as program length increased. LIMITATIONS: All trials had a high risk of bias, and most had a high rate of attrition. Most trials included people more than 6 months after stroke and who walked independently, limiting the generalizability of the findings. CONCLUSIONS: Exercising at an intensity greater than 70% of heart rate reserve can be more effective in increasing cardiorespiratory fitness after stroke than exercising at lower intensities. More trials that compare exercise doses by manipulating only 1 dose parameter at a time for people after stroke are needed.
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Capacidad Cardiovascular , Terapia por Ejercicio , Rehabilitación de Accidente Cerebrovascular , HumanosRESUMEN
Background: Accessing suitable fitness programs post-stroke is difficult for many. The feasibility of telehealth delivery has not been previously reported. Objectives: To assess the feasibility of, and level of satisfaction with home-based telehealth-supervised aerobic exercise training post-stroke. Methods: Twenty-one ambulant participants (≥ 3 months post-stroke) participated in a home-based telehealth-supervised aerobic exercise program (3 d/week, moderate-vigorous intensity, 8-weeks) and provided feedback via questionnaire post-intervention. Session details, technical issues, and adverse events were also recorded. Results: Feasibility was high (83% of volunteers met telehealth eligibility criteria, 85% of sessions were conducted by telehealth, and 95% of participants rated usability favourably). Ninety-five percent enjoyed telehealth exercise sessions and would recommend them to others. The preferred telehealth exercise program parameters were: frequency 3 d/week, duration 20-30 min/session, program length 6-12 weeks. Conclusion: The telehealth delivery of exercise sessions to people after stroke appears feasible and may be considered as a viable alternative delivery means for providing supervised exercise post-stroke.