Secondary prevention of stroke. A telehealth-delivered physical activity and diet pilot randomized trial (ENAbLE-pilot).

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.

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.

Using an integrated knowledge translation or other research partnership approach in trainee-led research: a scoping review protocol.

INTRODUCTION: Collaborative research approaches, such as co-production, co-design, engaged scholarship and integrated knowledge translation (IKT), aim to bridge the evidence to practice and policy gap. There are multiple benefits of collaborative research approaches, but studies report many challenges with establishing and maintaining research partnerships. Researchers often do not have the opportunity to learn how to build collaborative relationships, and most graduate students do not receive formal training in research partnerships. We are unlikely to make meaningful progress in strengthening graduate and postgraduate training on working collaboratively with the health system until we have a better understanding of how students are currently engaging in research partnership approaches. In response, this scoping review aims to map and characterise the evidence related to using an IKT or other research partnership approach from the perspective of health research trainees. METHODS AND ANALYSIS: We will employ methods described by the Joanna Briggs Institute and Arksey and O'Malley's framework for conducting scoping reviews. The reporting will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for scoping reviews checklist. We will include both published and unpublished grey literature and search the following databases: MEDLINE, Embase, CINAHL, PsycINFO, ProQuest Dissertations & Theses Global databases, Google Scholar and websites from professional bodies and other organisations. Two reviewers will independently screen the articles and extract data using a standardised data collection form. We will narratively describe quantitative data and conduct a thematic analysis of qualitative data. We will map the IKT and other research partnership activities onto the Knowledge to Action cycle and IAP2 Levels of Engagement Framework. ETHICS AND DISSEMINATION: No ethical approval is required for this study. We will share the results in a peer-reviewed, open access publication, conference presentation and stakeholder communications.

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.

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.

Supervised exercise delivered via telehealth in real time to manage chronic conditions in adults: a protocol for a scoping review to inform future research in stroke survivors.

INTRODUCTION: Increasing physical activity reduces secondary stroke risk factors, but many stroke survivors have low levels of physical activity. Supervised exercise delivered via telehealth has the potential to overcome barriers to increased physical activity in stroke survivors. Our scoping review will examine the emerging field of supervised exercise delivered via telehealth to map the available evidence in relation to its efficacy, acceptability, safety and feasibility in chronic conditions to inform future research into its ability to increase physical activity. METHODS AND ANALYSIS: The methodological framework of Arksey and O'Malley will be applied to our scoping review. A systematic search of Medline, CINAHL, Scopus, Cochrane, Pedro and Embase; hand searching of pertinent studies' reference lists; and consultation with experts in the field will identify relevant papers. Studies involving participants with a chronic condition who undertake supervised exercise delivered by a health professional via telehealth targeted at improving secondary stroke risk factors or involving lower limb weight-bearing exercise will be included. Study selection and critical appraisal of individual studies will be carried out independently by two authors with discrepancies resolved by a third author. Quantitative and qualitative data will be charted using a standardised form. Results will be tabulated and narratively summarised to highlight findings relevant to the review's research questions and to inform recommendations for future research. ETHICS AND DISSEMINATION: Our review will significantly contribute to the knowledge base of exercise and rehabilitation delivered via telehealth and its application in chronic conditions, including stroke. Findings will be relevant to researchers, healthcare workers and policy-makers and will be disseminated through publication and presentations. Only secondary deidentified data will be included, therefore ethics approval will not be sought. This protocol is not registered as PROSPERO currently excludes scoping reviews.

Changes in balance and walking from stroke rehabilitation to the community: a follow-up observational study.

OBJECTIVES: To investigate (1) whether clinical test scores at discharge predict falls or limited community mobility after discharge from inpatient stroke rehabilitation; and (2) how walking and dynamic standing balance change after discharge. DESIGN: Follow-up observational study between 6 and 36 months after discharge. SETTING: Rehabilitation setting. PARTICIPANTS: Community-dwelling stroke survivors (N=30) who could walk unassisted when discharged from inpatient rehabilitation. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Six-minute walk test (6MWT), Four Square Step Test (FSST), Step Test (ST), Environmental Analysis of Mobility Questionnaire (EAMQ), Falls Efficacy Scale-International (FES-I), and self-reported falls. RESULTS: Follow-up occurred at a median of 14.5 months postdischarge. Significant improvements occurred between discharge and follow-up for the 6MWT (mean difference [MD]=110.1m; 95% confidence interval [CI], 70.8-149.4; P<.001), ST (MD=1.8 steps; 95% CI, 0.3-3.4; P=.03), and FSST (MD=4.3s; 95% CI, -10.3 to 1.6; P=.05). Despite this, 40% of participants reported falling. The group who fell had lower clinical test scores at discharge and follow-up than nonfallers. Specific cutoff scores for the clinical tests accurately classified falls history in 70% to 78% of participants. The cutoff scores were <250m for the 6MWT, <10 steps on the ST, and a failure or ≥15 seconds to complete the FSST. Participants performing under the cutoff scores reported lower levels of community mobility (EAMQ, P<.04). Concern about falling was only higher for those classified at risk by the FSST (FES-I, P=.008). CONCLUSIONS: The FSST, ST, and 6MWT scores at discharge had good falls prediction. People classified at risk of falls avoided more tasks in their home and community than those not classified at risk.