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Stroke Prevention Rehabilitation Intervention Trial of Exercise (SPRITE) - a randomised feasibility study.

ABSTRACT: BACKGROUND:The value of cardiac rehabilitation (CR) after a transient ischaemic attack (TIA) or minor stroke is untested despite these conditions sharing similar pathology and risk factors to coronary heart disease. We aimed to evaluate the feasibility of conducting a trial of an adapted home-based CR programme, 'The Healthy Brain Rehabilitation Manual', for patients following a TIA/minor stroke, participants' views on the intervention and, to identify the behaviour change techniques (BCTs) used. METHODS:Clinicians were asked to identify patients attending the Ulster Hospital, Belfast within 4 weeks of a first TIA or minor stroke. Those who agreed to participate underwent assessments of physical fitness, cardiovascular risk, quality of life and mental health, before random allocation to: Group (1) standard/usual care; (2) rehabilitation manual or (3) manual plus pedometer. All participants received telephone support at 1 and 4 weeks, reassessment at 6 weeks and an invitation to a focus group exploring views regarding the study. Two trained review authors independently assessed the manual to identify the BCTs used. RESULTS:Twenty-eight patients were invited to participate, with 15 (10 men, 5 women; 9 TIA, 6 minor stroke; mean age 69 years) consenting and completing the study. Mean time to enrolment from the TIA/stroke was 20.5 days. Participants completed all assessment measures except VO2max testing, which all declined. The manual and telephone contact were viewed positively, as credible sources of advice. Pedometers were valued highly, particularly for goal-setting. Overall, 36 individual BCTs were used, the commonest being centred around setting goals and planning as well as social support. CONCLUSION:Recruitment and retention rates suggest that a trial to evaluate the effectiveness of a novel home-based CR programme, implemented within 4 weeks of a first TIA/minor stroke is feasible. The commonest BCTs used within the manual revolve around goals, planning and social support, in keeping with UK national guidelines. The findings from this feasibility work have been used to further refine the next stage of the intervention's development, a pilot study. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT02712385 . This study was registered prospectively on 18/03/2016.

SUBMITTER: Heron N

PROVIDER: S-EPMC5727948 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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Stroke Prevention Rehabilitation Intervention Trial of Exercise (SPRITE) - a randomised feasibility study.

Heron Neil N Kee Frank F Mant Jonathan J Reilly Philip M PM Cupples Margaret M Tully Mark M Donnelly Michael M

BMC cardiovascular disorders 20171212 1

<h4>Background</h4>The value of cardiac rehabilitation (CR) after a transient ischaemic attack (TIA) or minor stroke is untested despite these conditions sharing similar pathology and risk factors to coronary heart disease. We aimed to evaluate the feasibility of conducting a trial of an adapted home-based CR programme, 'The Healthy Brain Rehabilitation Manual', for patients following a TIA/minor stroke, participants' views on the intervention and, to identify the behaviour change techniques (BC ...[more]

PMID: 29233087

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Project description:IntroductionEffective interventions to promote upper-limb recovery poststroke are characterised by intensive and repetitive movements. However, the repetitive nature of practice may adversely impact on adherence. Therefore, the development of rehabilitation devices that can be used safely and easily at home, and are motivating, enjoyable and affordable is essential to the health and well-being of stroke survivors.The Neurofenix platform is a non-immersive virtual reality device for poststroke upper-limb rehabilitation. The platform uses a hand controller (a NeuroBall) or arm bands (NeuroBands) that facilitate upper-limb exercise via games displayed on a tablet. The Rehabilitation via HOMe Based gaming exercise for the Upper-limb post Stroke trial aims to determine the safety, feasibility and acceptability of the Neurofenix platform for home-based rehabilitation of the upper-limb poststroke.Methods and analysisThirty people poststroke will be provided with a Neurofenix platform, consisting of a NeuroBall or NeuroBands (dependent on impairment level), seven specially designed games, a tablet and handbook to independently exercise their upper limb for 7 weeks. Training commences with a home visit from a research therapist to teach the participant how to safely use the device. Outcomes assessed at baseline and 8 weeks and 12 weeks are gross level of disability, pain, objectively measured arm function and impairment, self-reported arm function, passive range of movement, spasticity, fatigue, participation, quality of life (QOL) and health service use. A parallel process evaluation will assess feasibility, acceptability and safety of the intervention through assessment of fidelity to the intervention measured objectively through the Neurofenix platform, a postintervention questionnaire and semistructured interviews exploring participants' experiences of the intervention. The feasibility of conducting an economic evaluation will be determined by collecting data on QOL and resource use.Ethics and disseminationEthics approval granted from Brunel University London (10249-MHR-Mar/2018-12322-2). Trial results will be submitted for publication in journals, presented at national and international conferences and distributed to people with stroke.Trial registration numberISRCTN60291412; Pre-results.

Project description:In 2011, more than half of the patients with stroke in Australian hospitals were not assessed for the need for rehabilitation. Further, there were no recommended criteria to guide rehabilitation assessment decisions. Subsequently, a decision-making tool called the Assessment for Rehabilitation Tool (ART) was developed. The ART was designed to assist Australian hospital clinicians to identify the rehabilitation needs of patients with stroke using evidence-based criteria. The ART was released and made freely available for use in 2012. This study evaluated the effectiveness of an education-only intervention (1 onsite education session and distribution of the ART) and a multifaceted intervention (2 or more onsite education sessions, distribution of the ART, audit and feedback, barrier identification, site-specific strategy development, promotion of interdisciplinary teamwork, opinion leaders and reminders) for improving assessments of rehabilitation needs after stroke.Ten hospitals in 2 states of Australia were randomly assigned to an education-only or a multifaceted intervention. Medical records were audited by assessors blinded to group allocation before and after the implementation period. Difference in the proportion of patients assessed for rehabilitation before and after the intervention was analysed using mixed-effects logistic regression analysis, with time period as the dependent variable, an interaction between intervention type and time included to test for differences between the interventions, and hospital included as the random effect to account for patient clustering.Data from 586 patients (284 pre-intervention; 302 post-intervention; age 76 years, 59 % male) showed that the multifaceted intervention was not more effective than education-only in improving the proportion of patients whose rehabilitation needs were assessed (reference category education-only; odds ratio 1.29, 95 % confidence interval 0.63-2.67, p = 0.483). Post-intervention, the odds of a patient's rehabilitation needs being assessed was 3.69 times greater than pre-intervention (95 % confidence interval 2.57-5.30, p < 0.001). Evidence-based criteria were not consistently used when patients were deemed to have no rehabilitation needs.A multifaceted intervention was not more effective than education-only in improving the assessment of rehabilitation needs of patients with stroke. Further interventions are required to ensure that all patients are assessed for the need for rehabilitation using evidence-based criteria.ANZCTR (Australian New Zealand Clinical Trials Registry), ACTRN12616000340437.

Project description:BACKGROUND:While cardiac rehabilitation has been shown to be effective at improving coronary heart disease (CHD), participation is generally poor. Attempts to increase uptake and adherence often fail. Use of a Facebook intervention for this population may be a unique opportunity to support self-determined motivation and affect adherence. OBJECTIVE:To evaluate the impact of a Facebook intervention on motivation for exercise and adherence to cardiac rehabilitation in patients with CHD during a 12-week, Phase II cardiac rehabilitation program. METHODS:A prospective, randomized controlled pilot study, grounded in Self-Determination Theory, will be conducted. Participants will be recruited from inpatient, or the intake visit to outpatient, cardiac rehabilitation, and then randomly assigned to the intervention or comparison group. Participants in the intervention group will take part in a private Facebook group. Weekly posts will be designed to support self-determined motivation, measured at baseline and postcardiac rehabilitation by the Behavioral Regulation in Exercise Questionnaire-3 (BREQ-3). The Psychological Need Satisfaction for Exercise (PNSE) scale will measure fulfillment of needs that affect motivation. Participants in the comparison group will be given the same materials, but these will be supplied via handouts and email. The number of sessions attended will be tallied and analyzed using t tests. Overall motivation will be evaluated using analysis of covariance (ANCOVA) models. Multivariate analysis of variance models will be used to evaluate differences in the change across motivation subtypes. If significant, ANCOVA models for each subtype will be fit. ANCOVA models will be used to compare changes in needs satisfaction, overall and separately among the three subscales, between groups. Engagement in the Facebook group will be measured by number of "likes" and self-report of weekly visits to the group. RESULTS:This project was funded in July 2017 and recruitment is currently underway. The recruitment goal is 60 cardiac rehabilitation patients. Data collection is anticipated to be complete by July 2018. CONCLUSIONS:This pilot study will be the first to examine the effect of a Facebook intervention on patient adherence and motivation for exercise in a cardiac rehabilitation setting. Engagement in the Facebook group and participation in the study will help to determine the feasibility of using Facebook to affect adherence and motivation in cardiac rehabilitation patients, potentially improving outcomes through the use of a unique intervention. TRIAL REGISTRATION:ClinicalTrials.gov NCT02971813; https://clinicaltrials.gov/ct2/show/NCT02971813 (Archived by WebCite at http://www.webcitation.org/6sRsz8Zpa).

Project description:BackgroundThe adherence to cardiac rehabilitation is low. Social media has been used to improve motivation and cardiac rehabilitation completion, but the authors did not find Facebook interventions for these purposes in the literature.ObjectiveThe purpose of this study was to determine the feasibility of the Cardiac Rehabilitation Facebook Intervention (Chat) for affecting changes in exercise motivation and need satisfaction and adherence to cardiac rehabilitation.MethodsThe Behavioral Regulation in Exercise Questionnaire-3 and Psychological Need Satisfaction for Exercise were used to measure motivation and need satisfaction (competence, autonomy, and relatedness) before and after the Chat intervention. To support need satisfaction, the intervention included educational posts, supportive posts, and interaction with peers. The feasibility measures included recruitment, engagement, and acceptability. Groups were compared using analysis of variance and Kruskal-Wallis tests. Paired t tests were used to assess motivation and need satisfaction change, and Pearson or Spearman correlations were used for continuous variables.ResultsA total of 32 participants were lost to follow-up and 22 were included in the analysis. Higher motivation at intake (relative autonomy index 0.53, 95% CI 0.14-0.78; P=.01) and change in need satisfaction-autonomy (relative autonomy index 0.61, 95% CI 0.09-0.87; P=.02) were associated with more completed sessions. No between-group differences were found. Engagement included "likes" (n=210) and "hits" (n=157). For acceptability, mean scores on a 1 (not at all) to 5 (quite a bit) Likert scale for feeling supported and in touch with providers were 4.6 and 4.4, respectively.ConclusionsAcceptability of the Chat group was high; however, intervention feasibility could not be determined due to the small sample size. Those with greater motivation at intake completed more sessions, indicating its importance in cardiac rehabilitation completion. Despite challenges with recruitment and engagement, important lessons were learned.Trial registrationClinicalTrials.gov NCT02971813; https://clinicaltrials.gov/ct2/show/NCT02971813.International registered report identifier (irrid)RR2-10.2196/resprot.7554.

Project description:BackgroundHigh levels of childhood obesity have been observed globally over the last three decades. Preschools are promising settings to implement obesity prevention interventions in the early years. The aim of this study was to test the feasibility of a cluster randomised controlled trial of the ToyBox-Scotland preschool obesity prevention intervention.MethodsSix preschools in predominantly deprived areas of Glasgow, UK, were randomised to either the ToyBox intervention (n = 3) or usual curriculum control group (n = 3). The intervention ran for 18 weeks from March-June 2018, and consisted of practitioner-led physical activity and sedentary behaviour sessions in preschools, with an additional interactive home component. Primary outcome measures were intervention fidelity, recruitment rates, attrition rates, and compliance with trial procedures. Secondary outcomes were body mass index (BMI) z-score, bioelectrical impedance analysis (BIA), objectively measured physical activity and sedentary time via activPAL accelerometer, and parent-reported home eating, snacking, and water consumption.ResultsThe preschool component of the intervention was implemented with high fidelity (64%), while the home component was implemented with low fidelity (41%). A cluster-level recruitment rate of 10% was achieved, and the individual-level recruitment rate was 18% (42/233 children, mean age 4.4 years; 17 girls). The attrition rate was 14%, and compliance rates varied considerably by the outcome. Compliance was highest for BMI (86%), while 19% of the sample returned valid accelerometer data for both baseline and follow-up and the parental questionnaire response rate was 23%. Both intervention and control groups showed small increases in BMI z-scores at follow-up of 0.02 and 0.06, respectively. Both groups had small decreases in physical activity and increases in sedentary time at follow-up.ConclusionsBefore progression to an effectiveness trial, additional procedures should be considered to improve recruitment rates, compliance with outcome measures, and implementation of the home-based component of the ToyBox-Scotland intervention.Trial registrationISRCTN12831555.

Project description:BackgroundThere is a dearth of research to support the treatment of people with postural tachycardia syndrome (PoTS). Despite expert consensus suggesting exercise is recommended for this patient group, there are no randomised control trials examining this rigorously. The aim was to co-create a feasibility trial protocol and a rehabilitation intervention for people living with PoTS.MethodsThe intervention and feasibility trial design were co-created as part of the PostUraL tachycardia Syndrome Exercise (PULSE) study. We used the 'three co's framework' of co-define, co-design and co-refine. Recruitment included key national charities and National Health Service Trusts treating people living with PoTS in the UK. Eighteen patient and public involvement members attended the co-define session, and 16 co-creators with a mix of expertise attended the subsequent co-design and co-refine sessions. Seven intervention practitioners were trained in the rehabilitation intervention, providing feedback for further co-refinement.ResultsThe final co-created intervention comprises online physical activity, and lifestyle and behaviour change support sessions. It is based on functional movement activities using a patient-centred approach tailored to individual needs. Physical activity intensity is guided by individuals' perception of effort rather than by objective measures. Recumbent bikes are provided for home use. Patients deemed randomisation to be acceptable because research in this area was considered important.ConclusionsAn innovative approach was used to co-create the PULSE intervention and feasibility trial protocol to meet the evidence-based and logistical needs of people living with PoTS, clinicians, service deliverers, third-sector organisations, academics and funders. This can be used as a successful example and template for future research internationally. People living with PoTS were recognised as experts and involved in every aspect of conceptualisation, design and refinement. This complex rehabilitation intervention is currently being tested in a randomised feasibility trial comparing the PULSE intervention with best-practice usual care for people living with PoTS.Trial registrationISRCTN45323485 was registered on April 7, 2020.

Project description:IntroductionReducing length of hospital stay for stroke survivors often creates a shift in the responsibility of care towards informal carers. Adjustment to the caregiving process is experienced by many carers as overwhelming, complex and demanding and can have a detrimental impact on mental and physical health and well-being. National policy guidelines recommend that carers' needs are considered and addressed; despite this, few interventions have been developed and empirically evaluated. We developed a biopsychosocial intervention in collaboration with carers of stroke survivors. Our aim is to determine whether the intervention can be delivered in a group setting and evaluated using a randomised controlled trial (RCT).Methods and analysisFeasibility RCT and nested qualitative interview study. We aim to recruit up to 40 stroke carers within 1 year of the stroke onset. Carers are randomised to usual care or usual care plus biopsychosocial intervention. Each intervention group will consist of five stroke carers. The intervention will focus on: psychoeducation, psychological adjustment to stroke, strategies for reducing unwanted negative thoughts and emotions and problem-solving strategies. The main outcome is the feasibility of conducting an RCT. Carer outcomes at 6 months include: anxiety and depression, quality of life and carer strain. Data are also collected from stroke survivors at baseline and 6 months including: level of disability, anxiety and depression, and quality of life.Ethics and disseminationFavourable ethical opinion was provided by East Midlands - Nottingham2 Research Ethics Committee (14/EMI/1264). This study will determine whether delivery of the biopsychosocial intervention is feasible and acceptable to stroke carers within a group format. It will also determine whether it is feasible to evaluate the effects of the biopsychosocial intervention in an RCT. We will disseminate our findings through peer-reviewed publications and presentations at national and international conferences.Trial registration numberISRCTN15643456; Pre-results.

Dataset Information

Stroke Prevention Rehabilitation Intervention Trial of Exercise (SPRITE) - a randomised feasibility study.

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Stroke Prevention Rehabilitation Intervention Trial of Exercise (SPRITE) - a randomised feasibility study.

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