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A randomised controlled trial evaluating family mediated exercise (FAME) therapy following stroke.

ABSTRACT: Stroke is a leading cause of disability among adults worldwide. Evidence suggests that increased duration of exercise therapy following stroke has a positive impact on functional outcome following stroke. The main objective of this randomised controlled trial is to evaluate the impact of additional family assisted exercise therapy in people with acute stroke.A prospective multi-centre single blind randomised controlled trial will be conducted. Forty patients with acute stroke will be randomised into either an experimental or control group. The experimental group will receive routine therapy and additional lower limb exercise therapy in the form of family assisted exercises. The control group will receive routine therapy with no additional formal input from their family members. Participants will be assessed at baseline, post intervention and followed up at three months using a series of standardised outcome measures. A secondary aim of the project is to evaluate the impact of the family mediated exercise programme on the person with stroke and the individual(s) assisting in the delivery of exercises using a qualitative methodology. The study has gained ethical approval from the Research Ethics Committees of each of the clinical sites involved in the study.This study will evaluate a structured programme of exercises that can be delivered to people with stroke by their 'family members/friends'. Given that the progressive increase in the population of older people is likely to lead to an increased prevalence of stroke in the future, it is important to reduce the burden of this illness on the individual, the family and society. Family mediated exercises can maximise the carry over outside formal physiotherapy sessions, giving patients the opportunity for informal practice.The protocol for this study is registered with the US NIH Clinical trials registry (NCT00666744).

SUBMITTER: Galvin R

PROVIDER: S-EPMC2447850 | biostudies-literature | 2008 Jun

REPOSITORIES: biostudies-literature

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A randomised controlled trial evaluating family mediated exercise (FAME) therapy following stroke.

Galvin Rose R Cusack Tara T Stokes Emma E

BMC neurology 20080620

<h4>Background</h4>Stroke is a leading cause of disability among adults worldwide. Evidence suggests that increased duration of exercise therapy following stroke has a positive impact on functional outcome following stroke. The main objective of this randomised controlled trial is to evaluate the impact of additional family assisted exercise therapy in people with acute stroke.<h4>Methods/design</h4>A prospective multi-centre single blind randomised controlled trial will be conducted. Forty pati ...[more]

PMID: 18570643

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Project description:BackgroundWhile existing psychological treatments for depression are effective for many, a significant proportion of depressed individuals do not respond to current approaches and few remain well over the long-term. Anhedonia (a loss of interest or pleasure) is a core symptom of depression which predicts a poor prognosis but has been neglected by existing treatments. Augmented Depression Therapy (ADepT) has been co-designed with service users to better target anhedonia alongside other features of depression. This mixed methods pilot trial aims to establish proof of concept for ADepT and to examine the feasibility and acceptability of a future definitive trial evaluating the clinical and cost-effectiveness of ADepT, compared to an evidence-based mainstream therapy (Cognitive Behavioural Therapy; CBT) in the acute treatment of depression, the prevention of subsequent depressive relapse, and the enhancement of wellbeing.MethodsWe aim to recruit 80 depressed participants and randomise them 1:1 to receive ADepT (15 weekly acute and 5 booster sessions in following year) or CBT (20 weekly acute sessions). Clinical and health economic assessments will take place at intake and at 6-, 12-, and 18-month follow-up. Reductions in PHQ-9 depression severity and increases in WEMWBS wellbeing at 6-month assessment (when acute treatment should be completed) are the co-primary outcomes. Quantitative and qualitative process evaluation will assess mechanism of action, implementation issues, and contextual moderating factors. To evaluate proof of concept, intake-post effect sizes and the proportion of individuals showing reliable and clinically significant change on outcome measures in each arm at each follow-up will be reported. To evaluate feasibility and acceptability, we will examine recruitment, retention, treatment completion, and data completeness rates and feedback from patients and therapists about their experience of study participation and therapy. Additionally, we will establish the cost of delivery of ADepT.DiscussionWe will proceed to definitive trial if any concerns about the safety, acceptability, feasibility, and proof of concept of ADepT and trial procedures can be rectified, and we recruit, retain, and collect follow-up data on at least 60% of the target sample.Trial registrationISCRTN85278228, registered 27/03/2017.

Project description:OBJECTIVE:The Pragmatic Ischaemic Thrombectomy Evaluation (PISTE) trial was a multicentre, randomised, controlled clinical trial comparing intravenous thrombolysis (IVT) alone with IVT and adjunctive intra-arterial mechanical thrombectomy (MT) in patients who had acute ischaemic stroke with large artery occlusive anterior circulation stroke confirmed on CT angiography (CTA). DESIGN:Eligible patients had IVT started within 4.5?hours of stroke symptom onset. Those randomised to additional MT underwent thrombectomy using any Conformité Européene (CE)-marked device, with target interval times for IVT start to arterial puncture of <90?min. The primary outcome was the proportion of patients achieving independence defined by a modified Rankin Scale (mRS) score of 0-2 at day 90. RESULTS:Ten UK centres enrolled 65 patients between April 2013 and April 2015. Median National Institutes of Health Stroke Scale score was 16 (IQR 13-21). Median stroke onset to IVT start was 120?min. In the intention-to-treat analysis, there was no significant difference in disability-free survival at day 90 with MT (absolute difference 11%, adjusted OR 2.12, 95% CI 0.65 to 6.94, p=0.20). Secondary analyses showed significantly greater likelihood of full neurological recovery (mRS 0-1) at day 90 (OR 7.6, 95% CI 1.6 to 37.2, p=0.010). In the per-protocol population (n=58), the primary and most secondary clinical outcomes significantly favoured MT (absolute difference in mRS 0-2 of 22% and adjusted OR 4.9, 95% CI 1.2 to 19.7, p=0.021). CONCLUSIONS:The trial did not find a significant difference between treatment groups for the primary end point. However, the effect size was consistent with published data and across primary and secondary end points. Proceeding as fast as possible to MT after CTA confirmation of large artery occlusion on a background of intravenous alteplase is safe, improves excellent clinical outcomes and, in the per-protocol population, improves disability-free survival. TRIAL REGISTRATION NUMBER:NCT01745692; Results.

Project description:BackgroundThere is increasing evidence of weight regain in patients after bariatric surgery (BS), generally occurring from 12 to 24 months postoperatively. Postoperative exercise has been suggested to ad long-term weight maintenance and to improve physical function in BS patients. However, there are a limited number of intervention studies investigating the possible benefits of exercise in this population. The aim of the current report is to provide a comprehensive CERT (Consensus on Exercise Reporting Template)-based description of the rationale and details of the exercise programme implemented in the EFIBAR Study (Ejercicio FÍsico tras cirugía BARiátrica), a randomised controlled trial investigating the effects of a 16-week supervised concurrent (aerobic and strength) exercise intervention program on weight loss (primary outcome), body composition, cardiometabolic risk, physical fitness, physical activity and quality of life (secondary outcomes) in patients with severe/morbid obesity following bariatric surgery.MethodsA total of 80 BS patients [60-80% expected women, aged 18 to 60 years, body mass index (BMI) ≥ 40 kg/m2 or ≥ 35 kg/m2 with comorbid conditions)] will be enrolled in the EFIBAR Randomized Control Trial (RCT). Participants allocated in the exercise group (n = 40) will undertake a 16-week supervised concurrent (strength and aerobic) exercise programme (three sessions/week, 60 min/session), starting 7 to 14 days after surgery. The rationale of the exercise programme will be described following the CERT criteria detailing the 16 key items. The study has been reviewed and approved by the Ethics Committee of the Torrecárdenas University Hospital (Almería, Spain) (ref. N° 76/2016).DiscussionThe present study details the exercise programme of the EFIBAR RCT, which may serve: 1) exercise professionals who would like to implement an evidence-based exercise programme for BS patients, and 2) as an example of the application of the CERT criteria.Trial registrationThe trial was prospectively registered at Clinicaltrials.gov NCT03497546 on April 13, 2018.

Project description:INTRODUCTION:Stroke is one of the primary causes of death and disability worldwide, leaving a considerable proportion of survivors with persistent cognitive and functional deficits. Despite the prevalence of poststroke cognitive impairment, there is no established treatment aimed at improving cognitive function following a stroke. Therefore, the aims of this systematic review are to identify psychological interventions intended to improve poststroke cognitive function and establish their efficacy. METHODS AND ANALYSIS:A systematic review of non-randomised controlled studies that investigated the efficacy of psychological interventions aimed at improving cognitive function in stroke survivors will be conducted. Electronic searches will be performed in the PubMed, Embase and PsycINFO databases, the search dating from the beginning of the index to February 2017. Reference lists of all identified relevant articles will be reviewed to identify additional studies not previously identified by the electronic search. Potential grey literature will be reviewed using Google Scholar. Titles and abstracts will be assessed for eligibility by one reviewer, with a random sample of 50% independently double-screened by second reviewers. Any discrepancies will be resolved through discussion, with referral to a third reviewer where necessary. Risk of bias will be assessed with the Risk of Bias in Non-randomized Studies of Interventions tool. Meta-analyses will be performed if studies are sufficiently homogeneous. This review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. The quality of the evidence regarding cognitive function will be assessed according to the Grading of Recommendations Assessment, Development and Evaluation. ETHICS AND DISSEMINATION:This systematic review will collect secondary data only and as such ethical approval is not required. Findings will be disseminated through presentations and peer-reviewed publication. This review will provide information on the effectiveness of psychological interventions for poststroke cognitive impairment, identifying which psychological interventions are effective for improving poststroke cognitive function. PROSPERO REGISTRATION NUMBER:CRD42017069714.

Project description:After experiencing a stroke, most individuals also suffer from cardiac disease, are immobile and thus have low endurance for exercise. Aerobic capacity is seriously reduced in these individuals and does not reach reasonable levels after conventional rehabilitation programmes. Cardiovascular exercise is beneficial for improvement of aerobic capacity in mild to moderate stroke. However, less is known about its impact on aerobic capacity, motor recovery, and quality-of-life in severely impaired individuals. The aim of this pilot study is to explore the clinical efficacy and feasibility of cardiovascular exercise with regard to aerobic capacity, motor recovery, and quality-of-life using feedback-controlled robotics-assisted treadmill exercise in non-ambulatory individuals soon after experiencing a stroke.This will be a single-centred single blind, randomised control trial with a pre-post intervention design. Subjects will be recruited early after their first stroke (?20 weeks) at a neurological rehabilitation clinic and will be randomly allocated to an inpatient cardiovascular exercise programme that uses feedback-controlled robotics-assisted treadmill exercise (experimental) or to conventional robotics-assisted treadmill exercise (control). Intervention duration depends on the duration of each subject's inpatient rehabilitation period. Aerobic capacity, as the primary outcome measure, will be assessed using feedback-controlled robotics-assisted treadmill-based cardiopulmonary exercise testing. Secondary outcome measures will include gait speed, walking endurance, standing function, and quality-of-life. Outcome assessment will be conducted at baseline, after each 4-week intervention period, and before clinical discharge. Ethical approval has been obtained.Whether cardiovascular exercise in non-ambulatory individuals early after stroke has an impact on aerobic capacity, motor recovery, and quality-of-life is not yet known. Feedback-controlled robotics-assisted treadmill exercise is a relatively recent intervention method and might be used to train and evaluate aerobic capacity in this population. The present pilot trial is expected to provide new insights into the implementation of early cardiovascular exercise for individuals with severe motor impairment. The findings of this study may guide future research to explore the effects of early cardiovascular activation after severe neurological events.This trial is registered with the Clinical Trials.gov Registry (NCT01679600).

Project description:IntroductionThe STRoke Interactive Virtual thErapy (STRIVE) intervention provides community-dwelling stroke survivors access to individualised, remotely supervised progressive exercise training via an online platform. This trial aims to determine the clinical efficacy of the STRIVE intervention and its effect on brain activity in community-dwelling stroke survivors.Methods and analysisIn a multisite, assessor-blinded randomised controlled trial, 60 stroke survivors >3 months poststroke with mild-to-moderate upper extremity impairment will be recruited and equally randomised by location (Melbourne, Victoria or Launceston, Tasmania) to receive 8 weeks of virtual therapy (VT) at a local exercise training facility or usual care. Participants allocated to VT will perform 3-5 upper limb exercises individualised to their impairment severity and preference, while participants allocated to usual care will be asked to maintain their usual daily activities. The primary outcome measures will be upper limb motor function and impairment, which will be assessed using the Action Research Arm Test and Upper Extremity Fugl-Meyer, respectively. Secondary outcome measures include upper extremity function and spasticity, as measured by the box and block test and Modified AshworthScale, respectively, and task-related changes in bilateral sensorimotor cortex haemodynamics during hand reaching and wrist extension movements as measured by functional near-infrared spectroscopy. Quality of life will be measured using the Euro-Quality of Life-5 Dimension-5 Level Scale, and the Motor Activity Log-28 will be used to measure use of the hemiparetic arm. All measures will be assessed at baseline and immediately postintervention.Ethics and disseminationThe study was approved by the Deakin University Human Research Ethics Committee in May 2017 (No. 2017-087). The results will be disseminated in peer-reviewed journals and presented at major international stroke meetings.Trial registration numberACTRN12617000745347; Pre-results.

Project description:INTRODUCTION:Children with cerebral palsy (CP) and other neurodevelopmental disabilities often receive a home programme of exercises to assist in reaching their therapy goals. Adherence to exercise programmes is necessary to attain the level of practice required to achieve goals; however, adherence can be difficult to accomplish. In this paper, we describe the protocol for a randomised controlled trial to evaluate the effectiveness of delivering a home exercise programme to school-age children with disabilities using Physitrack, an online exercise prescription tool with a website or app interface. METHODS AND ANALYSIS:Participants aged 6-17 years, with CP or other neurodevelopmental disabilities, receiving community physiotherapy services in Western Australia, will be recruited. Participants will be stratified by age and functional mobility and randomised to either the intervention group, who will complete an 8-week home exercise programme using Physitrack, or the control group, who will complete an 8-week exercise programme without Physitrack. Researcher blinding to group allocation, and participant blinding to outcome, will be maintained. The primary outcome measures are adherence to the home exercise programme with weekly collection of home exercise logs; achievement of individualised goals by phone interview before and after intervention; and correctness of exercise performance by collection and analysis of videos of participants performing home exercises. Secondary outcome measures include enjoyment of physical activity, confidence to complete exercise programme, preferred method of delivery of programme and usability of Physitrack. A sample size of 58 participants will be necessary to see an effect on home programme adherence. Data will be analysed using the intention-to-treat principle. ETHICS AND DISSEMINATION:Ethical approval was obtained from Curtin University Human Research Ethics Committee in July 2016 (10391). Outcomes will be disseminated through publication in peer-reviewed journals and presentations at scientific conferences. TRIAL REGISTRATION NUMBER:ACTRN12616000743460; Pre-results.

Project description:BackgroundIt is still unclear, which physiotherapeutic approaches are most effective in stroke recovery. Vojta therapy is a type of physiotherapy that was originally developed for children and adolescents with cerebral palsy. Vojta therapy has been reported to improve automatic control of body posture. Because acute stroke patients are characterised by a disturbance in the ability to adapt to changes in body position, requiring automatic postural adjustment, we decided to investigate Vojta therapy in the early rehabilitation of stroke patients. Aim of the trial was to test the hypothesis that Vojta therapy - as a new physiotherapeutic approach in early stroke recovery - improves postural control and motor function in patients with acute ischaemic stroke (AIS) or intracerebral haemorrhage (ICH).MethodsThis prospective, randomised controlled trial included patients with imaging-confirmed AIS or ICH, severe hemiparesis and randomly assigned them to Vojta therapy or standard physiotherapy within 72 h after stroke onset. Main exclusion criterion was restricted ability to communicate. Primary endpoint was the improvement of postural control measured by the Trunk Control Test (TCT) on day 9 after admission. Secondary endpoint among others was improvement of arm function (measured with Motor Evaluation Scale for Upper Extremity in Stroke Patients [MESUPES]).ResultsForty patients (20 per group) were randomised into the trial. Median age was 75 (66-80) years, 50% were women. The median improvement in TCT within 9 days was 25.5 points (=25.5%) (interquartile range [IQR] 12.5-42.5) in the Vojta group and 0 (IQR 0-13) in the control group (p = 0.001). Patients treated with Vojta therapy achieved a greater improvement in the MESUPES than patients in the control group (20% vs 10%, p = 0.006).ConclusionThis first randomised controlled trial of Vojta therapy in acute stroke patients demonstrates improvement of postural control through Vojta therapy compared to standard physiotherapy. Although this trial has some methodical weaknesses, Vojta therapy might be a promising approach in early stroke rehabilitation and should be studied in larger trials.Trial registrationClinicalTrials.gov; Unique identifier: NCT03035968. Registered 30 January 2017 - Retrospectively registered; http://www.clinicaltrials.gov.

Dataset Information

A randomised controlled trial evaluating family mediated exercise (FAME) therapy following stroke.

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A randomised controlled trial evaluating family mediated exercise (FAME) therapy following stroke.

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