How little is enough? The feasibility of conducting a dose-escalation study for exercise training in people with stroke.

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).

The Oxford Cognitive Screen for use with Australian people after stroke (OCS-AU): The adaptation process and determining cut scores for cognitive impairment using a cross-sectional normative study.

INTRODUCTION: Two parallel versions (A and B) of the Oxford Cognitive Screen (OCS) were developed in the United Kingdom (UK) as a stroke-specific screen of five key cognitive domains commonly affected post-stroke. We aimed to develop the Australian versions A and B (OCS-AU), including Australian cut-scores indicative of impairment. We hypothesised there to be no difference in performance between the UK and Australian normative data cohorts. METHODS: Our multidisciplinary expert panel used the UK pre-defined process to develop the OCS-AU versions A and B. We then conducted a cross-sectional normative study. We purposively recruited community-dwelling, Australian-born, and educated adults; with no known cognitive impairment; representative of age, sex, education level, and living location; at seven sites (four metropolitan, three regional) across four Australian states. Participants completed one or both OCS-AU versions in a randomised order. Australian cohorts were compared with the corresponding UK cohorts for demographics using Pearson's chi-squared test for sex and education, and Welch two-sample t test for age. For the cut-scores indicating cognitive impairment, the fifth (95th) percentiles and group mean performance score for each scored item were compared using Welch two-sample t tests. The pre-defined criteria for retaining OCS cut-scores had no statistically significant difference in either percentile or group mean scores for each scored item. RESULTS: Participants (n = 83) were recruited: fifty-eight completed version A [age (years) mean = 61,SD = 15; 62% female], 60 completed version B [age (years) mean = 62,SD = 13, 53% female], and 35 completed both [age (years) mean = 64,SD = 11, 54% female]. Education was different between the cohorts for version B (12 years, p = 0.002). Cut-scores for all 16 scored items for the OCS-AU version B and 15/16 for version A met our pre-defined criteria for retaining the OCS cut scores. CONCLUSIONS: The OCS-AU provides clinicians with an Australian-specific, first-line cognitive screening tool for people after stroke. Early screening can guide treatment and management.

Fit for purpose. Co-production of complex behavioural interventions. A practical guide and exemplar of co-producing a telehealth-delivered exercise intervention for people with stroke.

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.

Secondary Prevention of Stroke: Study Protocol for a Telehealth-Delivered Physical Activity and Diet Pilot Randomized Trial (ENAbLE-Pilot).

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.

Cardiorespiratory fitness and walking endurance improvements after 12 months of an individualised home and community-based exercise programme for people after stroke.

OBJECTIVE: To evaluate the immediate and longer-term effects of an individually tailored, home- and community-based exercise programme with ongoing remote support in people with stroke on cardiorespiratory fitness (CRF), ambulation and health-related quality of life (HRQoL). METHODS: Twenty people 5.3 ± 3.5 months post stroke completed the 12-week HowFITSS? exercise programme aimed at increasing CRF and daily physical activity. Support was provided by phone and email, which decreased in frequency over time. Participants were assessed at baseline, then at 3, 6 and 12 months after initiation of the intervention. CRF (VO2peak) was evaluated using a portable metabolic system during the 6-minute walk test (6MWT), the Shuttle Walk Test (SWT) and the cycle graded exercise test (cGXT). Walking speed, balance, body composition, fatigue, depression and HRQoL were also measured. RESULTS: CRF improved significantly from pre-intervention to 12-month follow-up on the 6MWT (Effect Size, ES = 0.87; p = 0.002) and cGXT (ES = 0.60; p < 0.001), with more modest improvements on the SWT (ES = 0.52; p = 0.251). From baseline to 12 months, significant within-participant improvements were found for self-selected walking speed, balance and HRQoL. Performances on the remaining tests were maintained over the post-intervention period. CONCLUSION: There may be health benefits of providing people with stroke an exercise intervention with long-term support that encourages increased regular physical activity.

Evaluating the feasibility and acceptability of the Mood Assessment Post-Stroke (MAPS) mood screening training.

Mood problems are common after stroke, and screening is recommended. Training may support staff knowledge and implementation of screening, but the feasibility of training programmes in the Australian healthcare system has not been formally established. This study aimed to assess the feasibility of a mood screening training for a multidisciplinary team (MDT) of stroke clinicians working in a post-acute inpatient rehabilitation service.Twelve staff from a rehabilitation service at a major hospital in Sydney, Australia participated in a 3-h interactive training session. The feasibility of running the course, assessment of knowledge gained via a consolidation exercise and quiz and acceptability of the training were assessed via focus groups.The in-person modality of the training hindered recruitment and assessment of participants' knowledge, though the actual measures themselves appeared appropriate. Nine participants provided feedback in two focus groups. Thematic analysis identified positive reactions to the training. However, low self-efficacy persisted and organisational/socio-cultural barriers to implementation emerged. Following training, the medical officers of the MDT had successfully implemented routine screening.Overall, the training appeared acceptable and to foster knowledge in staff. However, limitations to recruitment and administering evaluations were identified. The development of flexible online training may improve future evaluations of screening training programmes/pathways.

Look Before You Leap: Interventions Supervised via Telehealth Involving Activities in Weight-Bearing or Standing Positions for People After Stroke-A Scoping Review.

OBJECTIVE: The COVID-19 pandemic has seen a rapid shift to telehealth-delivered physical therapy services. Common impairments after stroke create unique challenges when providing rehabilitation via telehealth, particularly when it involves activities undertaken in weight-bearing or standing positions, including walking training. Our scoping review maps the evidence regarding safety, efficacy, and feasibility of remotely supervised telehealth interventions involving activities undertaken in weight-bearing or standing positions for people after stroke. METHODS: Searches of relevant databases for primary research studies were conducted using keywords relating to exercise and telehealth. Studies of stroke survivors undertaking interventions involving activities in weight-bearing or standing positions, supervised in real-time via telehealth were included. Two reviewers independently appraised all studies. Data were charted by one reviewer, checked by another, and results synthesized narratively. RESULTS: Seven studies (2 randomized trials, 1 mixed-methods, and 4 pre-post studies) were included, involving 179 participants. Some studies included stroke survivors with cognitive impairment, and 2 (29%) studies included only participants who walked independently. Adherence (reported in 3 studies) and satisfaction (reported in 4 studies) were good, and no serious adverse events (data from 4 studies) related to interventions were reported. Strategies to overcome technological barriers were used to optimize intervention safety and feasibility, along with physiological monitoring, caregiver assistance, and in-person exercise prescription. However, there is limited high-quality evidence of efficacy. CONCLUSIONS: We identified strategies used in research to date that can support current practice. However, urgent research is needed to ensure that stroke survivors are receiving evidence-based, effective services. IMPACT: The COVID-19 pandemic has necessitated a rapid shift to telerehabilitation services for people with stroke, but there is little evidence to guide best practice. Our review provides practical guidance and strategies to overcome barriers and optimize safety and adherence for telehealth interventions involving activities in weight-bearing or standing positions.

Trends in stroke attack rates and case fatality in the Hunter region, Australia 1996-2008.

BACKGROUND: The Hunter area in New South Wales, Australia, is a well-defined geographical area with a population of 578,486 (2006). This paper presents trends from 1996 to 2008 for prospectively registered hospital admissions of adults aged 20 years and above with acute stroke. METHOD: Crude, age-standardised and age-specific stroke attack rates per 100,000 population and case fatality rates at standard time points were calculated. A medical record audit of stroke and stroke mimics was undertaken to determine discharge coding accuracy. RESULTS: 9,796 acute stroke events were registered among 8,830 individuals at 14 public acute hospitals. Crude and age-standardised attack rates decreased consistently from 1996 to 2008. Crude rates fell from 184 to 176 per 100,000 population and age-standardised rates from 129 to 106 per 100,000 (attack rate reduction of 0.85% per year, p = 0.027; and 2.38% per year, p < 0.001, respectively). Annual attack rates for females were on average 27.70% (p < 0.001) lower than for males. Age-specific rates fell for each age bracket between 45 and 74 years. Case fatality rates remained constant. There was a 97.5% proportion of agreement between audit and coding. CONCLUSION: This study demonstrates falling stroke attack rates but stable case fatality over 13 years in a mixed urban and rural population of New South Wales, Australia. It suggests benefits from cardio- and cerebrovascular prevention strategies; however, it also indicates that stroke remains a major disease burden in this region.

The Feasibility of a Telehealth Exercise Program Aimed at Increasing Cardiorespiratory Fitness for People After Stroke.

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.

What Is the Dose-Response Relationship Between Exercise and Cardiorespiratory Fitness After Stroke? A Systematic Review.

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.

Evaluation of three measures of cardiorespiratory fitness in independently ambulant stroke survivors.

Measuring cardiorespiratory fitness (CRF) in the stroke population is challenging. Currently, the recommended method is a graded exercise test (GXT) on an ergometer such as a treadmill or cycle, which may not always be possible. We investigated whether walking tests such as the six-minute walk test (6MWT) and the shuttle walk test (SWT) may be appropriate indicators of CRF in the stroke population. Twenty-three independently ambulant stroke survivors (11 men, age 61.5 ± 18.4 years) within one-year post stroke performed the 6MWT, SWT, and cycle GXT, during which peak oxygen consumption (VO2peak) and heart rate (HRpeak) were recorded. There were no differences (p > 0.05) in mean VO2peak among the three tests (min-max: 17.08-18.09 mL kg-1 min-1). For individuals, small discrepancies in VO2peak between the 6MWT and other tests were greater with higher fitness levels. HRpeak was significantly (p = 0.005) lower during the 6MWT. Correlations between VO2peak and performance measures within each test were high (6MWT VO2peak and distance: r = 0.78, SWT VO2peak and shuttles: r = 0.73, cycle GXT VO2peak and workload: r = 0.77) suggesting the performance measures may be clinically useful as proxy measures of CRF. Common comorbidities, such as lower-limb joint pain and poor balance, and participant's fastest walking speed, should inform the choice of CRF test.

Independently ambulant, community-dwelling stroke survivors have reduced cardiorespiratory fitness, mobility and knee strength compared to an age- and gender-matched cohort.

BACKGROUND: Most exercise interventions for stroke survivors are designed for those who have substantial motor and functional disabilities. There remains a group of well-recovered stroke survivors who have yet to be investigated in terms of their physical capacity and fitness levels. OBJECTIVE: To assess and compare the physical capacities of independently ambulant, community-dwelling stroke survivors to age- and gender-matched comparison participants. METHODS: Data were obtained from 17 stroke survivors participating in the How FITSS? Trial, all with functional ambulatory category of ≥4 and a self-selected walking speed ≥0.8 m s-1. An additional 17 healthy control participants were recruited. Cardiorespiratory fitness (CRF) was measured using oxygen consumption (VO2peak), and additional measures of walking speed (m s-1), leg strength and body composition were also assessed. Differences between groups were assessed by matched pairs t-tests. Effect sizes were calculated using Cohen's d. RESULTS: There were no significant differences in age, BMI, muscle mass or body fat between groups (p > 0.05). Peak VO2 was lower in the stroke group for the shuttle walk test (p = 0.037) and progressive cycle test (p = 0.019), as were all CRF test performance measures (p < 0.05). Stroke survivors walked significantly (p < 0.001) slower at both self-selected and fast speeds. Effect sizes of group differences for all leg strength variables were medium to large, with peak torque lower in the stroke group for all trials. CONCLUSIONS: Despite being independently ambulant and community dwelling, the CRF, walking speed and leg strength of this group were reduced compared to non-stroke comparison participants. These patients may benefit from undertaking targeted exercise programmes.

Characteristics of exercise training interventions to improve cardiorespiratory fitness after stroke: a systematic review with meta-analysis.

BACKGROUND: Cardiorespiratory fitness is low after stroke. Improving fitness has the potential to improve function and reduce secondary cardiovascular events. OBJECTIVE: . This review with meta-analysis aims to identify characteristics and determine the effectiveness of interventions to improve cardiorespiratory fitness after stroke. METHODS: A systematic search and review with meta-analysis was undertaken. Key inclusion criteria were the following: peer-reviewed articles published in English, adult stroke survivors, an intervention with the potential to improve cardiorespiratory fitness, and peak oxygen consumption (VO2peak) assessed preintervention and postintervention via a progressive aerobic exercise test. RESULTS: From 3209 citations identified, 28 studies were included, reporting results for 920 participants. Studies typically included chronic, ambulant participants with mild to moderate deficits; used an aerobic or mixed (with an aerobic component) intervention; and prescribed 3 sessions per week for 30 to 60 minutes per session at a given intensity. Baseline VO2peak values were low (8-23 mL/kg/min). Meta-analysis of the 12 randomized controlled trials demonstrated overall improvements in VO2peak of 2.27 (95% confidence interval = 1.58, 2.95) mL/kg/min postintervention. A similar 10% to 15% improvement occurred with both aerobic and mixed interventions and in shorter (≤ 3 months) and longer (>3 months) length programs. Only 1 study calculated total dose received and only 1 included long-term follow-up. CONCLUSIONS: The results demonstrate that interventions with an aerobic component can improve cardiorespiratory fitness poststroke. Further investigation is required to determine effectiveness in those with greater impairment and comorbidities, optimal timing and dose of intervention, whether improvements can be maintained in the longer term, and whether improved fitness results in better function and reduced risk of subsequent cardiovascular events.

The rural Prehospital Acute Stroke Triage (PAST) trial protocol: a controlled trial for rapid facilitated transport of rural acute stroke patients to a regional stroke centre.

RATIONALE: Access to intravenous thrombolysis for acute ischaemic stroke is limited worldwide, particularly in regional and rural areas including in Australia. We are testing the effectiveness of a new rural Prehospital Acute Stroke Triage protocol that includes prehospital assessment and rapid transport of patients from a rural catchment to the major stroke centre in Newcastle, NSW, Australia. The local district hospitals within the rural catchment do not have the capability or infrastructure to deliver acute stroke thrombolysis. The trial has relevance to stroke clinicians, health service managers and planners responsible for rural populations. AIMS: To implement a system of rapid prehospital assessment and facilitated transport that will significantly increase stroke thrombolysis rates to 10% of ischaemic stroke cases in the rural catchment. Validate an eight-point modified National Institutes of Health Stroke Scale for use by paramedics in the prehospital setting to assess patients' potential eligibility for stroke thrombolysis. DESIGN: The joint project between the John Hunter Hospital Acute Stroke Team and the Ambulance Service of NSW will use a prospective cohort with an historical control group. Tools and protocols have been developed and education undertaken for ambulance field and operations centre personnel. These include a cut-down eight-item National Institutes of Health Stroke Scale (Hunter NIHSS-8) score to be used in the field by paramedics and a transport decision matrix to expedite transport for a suspected stroke patient (road or road plus air transport). OUTCOMES: The primary outcome measure will be the rate of intravenous tissue plasminogen activator delivery for those who suffer an ischaemic stroke following protocol implementation, in comparison with historical rates over a corresponding period prior to implementation, for residents within the catchment. Sixty cases are required in the postimplementation time epoch to demonstrate a statistically significant absolute increase in thrombolysis rates for ischaemic strokes from <1% to 10%, (power of 80%, α error of 0.05). The major secondary outcome will be inter-rater reliability of the Hunter NIHSS-8.