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Home-based physical activity incentive and education program in subacute phase of stroke recovery (Ticaa'dom): study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Stroke causes functional decline, psychological disorders and cognitive impairments that affect activities of daily living and quality of life. Although physical activity (PA) is beneficial in stroke recovery, PA recommendations are rarely met after hospital discharge. There is presently no standard strategy for monitoring and inciting PA at home during the subacute phase of stroke recovery. The main aim of this study is to evaluate the effects of a home-based physical activity incentive and education program (Ticaa'dom) on functional capacity in subacute stroke patients. METHODS:This study is a comparative prospective, observer-blinded, monocentric, parallel, randomized controlled clinical trial. This study will include 84 patients: 42 patients in the home-based physical activity incentive group (HB-PAI) and 42 in the control group (CG). The intervention group will follow the HB-PAI program over 6 months: their PA will be monitored with an accelerometer during the day at home while they record their subjective perception of PA on a chart; they will observe a weekly telephone call and a home visit every three weeks. The CG will receive traditional medical care over 12 months. The main study outcome will be the distance on a 6-minute walk test. Secondary outcomes will include measurements of lower limb strength, independence level, body composition, cardiac analysis, fatigue and depression state. DISCUSSION:The results of this trial will demonstrate the value of implementing the Ticaa'dom program during the subacute phase of stroke recovery. TRIAL REGISTRATION:ClinicalTrials.gov, NCT01822938 . Registered on 25 March 2013.

SUBMITTER: Chaparro D

PROVIDER: S-EPMC5785899 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

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Home-based physical activity incentive and education program in subacute phase of stroke recovery (Ticaa'dom): study protocol for a randomized controlled trial.

Chaparro David D Daviet Jean-Christophe JC Borel Benoit B Kammoun Benjamin B Salle Jean-Yves JY Tchalla Achille A Mandigout Stéphane S

Trials 20180125 1

<h4>Background</h4>Stroke causes functional decline, psychological disorders and cognitive impairments that affect activities of daily living and quality of life. Although physical activity (PA) is beneficial in stroke recovery, PA recommendations are rarely met after hospital discharge. There is presently no standard strategy for monitoring and inciting PA at home during the subacute phase of stroke recovery. The main aim of this study is to evaluate the effects of a home-based physical activit ...[more]

PMID: 29370824

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Project description:BACKGROUND:Given the rising number of strokes worldwide, and the large number of individuals left with disabilities after stroke, novel strategies to reduce disability, increase functions in the motor and the cognitive domains, and improve quality of life are of major importance. Physical activity is a promising intervention to address these challenges but, as yet, there is no study demonstrating definite outcomes. Our objective is to assess whether additional treatment in the form of physical fitness-based training for patients early after stroke will provide benefits in terms of functional outcomes, in particular gait speed and the Barthel Index (co-primary outcome measures) reflecting activities of daily living (ADL). We will gather secondary functional outcomes as well as mechanistic parameters in an exploratory approach. METHODS/DESIGN:Our phase III randomised controlled trial will recruit 215 adults with moderate to severe limitations of walking and ADL 5 to 45 days after stroke onset. Participants will be stratified for the prognostic variables of "centre", "age", and "stroke severity", and randomly assigned to one of two groups. The interventional group receives physical fitness training delivered as supported or unsupported treadmill training (cardiovascular active aerobic training; five times per week, over 4 weeks; each session 50 minutes; total of 20 additional physical fitness training sessions) in addition to standard rehabilitation treatment. The control intervention consists of relaxation sessions (non-cardiovascular active; five times per week week, over 4 weeks; each session 50 minutes) in addition to standard rehabilitation treatment. Co-primary efficacy endpoints will be gait speed (in m/s, 10 m walk) and the Barthel Index (100 points total) at 3 months post-stroke, compared to baseline measurements. Secondary outcomes include standard measures of quality of life, sleep and mood, cognition, arm function, maximal oxygen uptake, and cardiovascular risk factors including blood pressure, pulse, waist-to-hip ratio, markers of inflammation, immunity and the insulin-glucose pathway, lipid profile, and others. DISCUSSION:The goal of this endpoint-blinded, phase III randomised controlled trial is to provide evidence to guide post-stroke physical fitness-based rehabilitation programmes, and to elucidate the mechanisms underlying this intervention. TRIAL REGISTRATION:Registered in ClinicalTrials.gov with the Identifier NCT01953549.

Project description:IntroductionMany patients with stroke have moderate to severe long-term sensorimotor impairments, often including inability to execute movements of the affected arm or hand. Limited recovery from stroke may be partly caused by imbalanced interaction between the cerebral hemispheres, with reduced excitability of the ipsilesional motor cortex while excitability of the contralesional motor cortex is increased. Non-invasive brain stimulation with inhibitory repetitive transcranial magnetic stimulation (rTMS) of the contralesional hemisphere may aid in relieving a post-stroke interhemispheric excitability imbalance, which could improve functional recovery. There are encouraging effects of theta burst stimulation (TBS), a form of TMS, in patients with chronic stroke, but evidence on efficacy and long-term effects on arm function of contralesional TBS in patients with subacute hemiparetic stroke is lacking.Methods and analysisIn a randomised clinical trial, we will assign 60 patients with a first-ever ischaemic stroke in the previous 7-14 days and a persistent paresis of one arm to 10 sessions of real stimulation with TBS of the contralesional primary motor cortex or to sham stimulation over a period of 2?weeks. Both types of stimulation will be followed by upper limb training. A subset of patients will undergo five MRI sessions to assess post-stroke brain reorganisation. The primary outcome measure will be the upper limb function score, assessed from grasp, grip, pinch and gross movements in the action research arm test, measured at 3?months after stroke. Patients will be blinded to treatment allocation. The primary outcome at 3?months will also be assessed in a blinded fashion.Ethics and disseminationThe study has been approved by the Medical Research Ethics Committee of the University Medical Center Utrecht, The Netherlands. The results will be disseminated through (open access) peer-reviewed publications, networks of scientists, professionals and the public, and presented at conferences.Trial registration numberNTR6133.

Project description:BackgroundIndividuals requiring greater physical assistance to practice walking complete fewer steps in physical therapy during subacute stroke rehabilitation. Powered exoskeletons have been developed to allow repetitious overground gait training for individuals with lower limb weakness. The objective of this study was to determine the efficacy of exoskeleton-based physical therapy training during subacute rehabilitation for walking recovery in non-ambulatory patients with stroke.MethodsAn assessor-blinded randomized controlled trial was conducted at 3 inpatient rehabilitation hospitals. Patients with subacute stroke (< 3 months) who were unable to walk without substantial assistance (Functional Ambulation Category rating of 0 or 1) were randomly assigned to receive exoskeleton-based or standard physical therapy during rehabilitation, until discharge or a maximum of 8 weeks. The experimental protocol replaced 75% of standard physical therapy sessions with individualized exoskeleton-based sessions to increase standing and stepping repetition, with the possibility of weaning off the device. The primary outcome was walking ability, measured using the Functional Ambulation Category. Secondary outcomes were gait speed, distance walked on the 6-Minute Walk Test, days to achieve unassisted gait, lower extremity motor function (Fugl-Meyer Assessment), Berg Balance Scale, Patient Health Questionnaire, Montreal Cognitive Assessment, and 36-Item Short Form Survey, measured post-intervention and after 6 months.ResultsThirty-six patients with stroke (mean 39 days post-stroke) were randomized (Exoskeleton = 19, Usual Care = 17). On intention-to-treat analysis, no significant between-group differences were found in the primary or secondary outcomes at post-intervention or after 6 months. Five participants randomized to the Exoskeleton group did not receive the protocol as planned and thus exploratory as-treated and per-protocol analyses were undertaken. The as-treated analysis found that those adhering to exoskeleton-based physical therapy regained independent walking earlier (p = 0.03) and had greater gait speed (p = 0.04) and 6MWT (p = 0.03) at 6 months; however, these differences were not significant in the per-protocol analysis. No serious adverse events were reported.ConclusionsThis study found that exoskeleton-based physical therapy does not result in greater improvements in walking independence than standard care but can be safely administered at no detriment to patient outcomes. Clinical Trial Registration The Exoskeleton for post-Stroke Recovery of Ambulation (ExStRA) trial was registered at ClinicalTrials.gov (NCT02995265, first registered: December 16, 2016).

Project description:Cerebral ischemia/reperfusion injury (CI/RI), including neurological behavior deficits, cerebral infarction, blood-brain barrier (BBB) dysfunction, and neuroinflammation, et al. is a severe challenge in treatment of ischemic stroke. Traditional Chinese medicine (TCM) with the characteristics of multi-components and multi-functions for multiple targets/pathways has been historically used in the treatment of stroke and post stroke recovery in China. QiShenYiQi (QSYQ), a representative component-based Chinese medicine, is capable of reducing organ injury caused by ischemia/reperfusion via multiple mechanisms. Recently, we have previously reported that the positive action of QSYQ against the acute phase of CI/RI is partly via modulation of neuroinflammatory response. However, the effects and underlying mechanisms of QSYQ on subacute phase of CI/RI remain unknown, which are aimed to investigate in present study. The pharmacological action of QSYQ treatment on brain damage was estimated in the experimental stroke rats underwent 90 min ischemia and 8 days reperfusion by assessing the neurological and locomotor deficits, cerebral infarction, brain edema, and BBB integrity. Furthermore, we used TMT-based quantitative proteomics technology to identify significantly differentially expressed proteins following QSYQ treatment, which could give important clues for revealing the possible mechanism underlying the positive role of QSYQ in CI/RI. Besides, immunohistochemistry, western blot analysis, RT-qPCR, and rat ELISA kits were executed to further verify the accuracy of proteomics analysis results. As a consequence, we found that treatment with QSYQ (600mg/kg) for 7 days obviously improved neurological and behavioral impairment, attenuated infarct volume and brain edema, and alleviated BBB breakdown in stroke rats. Bioinformatics analysis suggested that differentially expressed protein galectin-3 mediated inflammatory response was closely related to the beneficial effect of QSYQ. Results of immunohistochemistry, western blot analysis and RT-qPCR showed that the model rats treated with QSYQ (600mg/kg) markedly downregulated the mRNA and protein expression level of galectin-3 in brain tissues compared to the untreated stroke rats. In addition, the decrease of mRNA level in brain tissues and contents in serum of TNF-α and IL-6 following QSYQ treatment were also observed. These interesting finding manifested that the effective action of QSYQ against subacute phase of CI/RI was partly via regulating galectin-3 mediated inflammatory reaction.

Project description:IntroductionStroke rehabilitation guidelines suggest a high-frequency task-oriented training at high intensity. A targeted and self-paced daily training with intermittent supervision is recommended to improve patients' self-management and functional output. So far, there is conflicting evidence concerning the most effective home-training delivery method.Methods and analysisThe purpose of this pilot study is to compare the feasibility and preliminary effects of task-oriented home-exercises in patients in the subacute stage after stroke. Twenty-four patients will be randomised (1:1) to a Video group (a) or Paper group (b) of an individualised, task-oriented home-training (50 min, 6×/week, for 4 weeks) based on Wulf and Lewthwaite's Optimizing Performance Through Intrinsic Motivation and Attention for Learning theory of motor learning. Patient-relevant goals will be identified using Goal Attainment Scaling and exercises progressively adapted. Semistructured interviews and a logbook will be used to monitor adherence, arm use and acceptability. Primary outcome will be the feasibility of the methods and a full-scale trial employing predefined feasibility criteria (recruitment, retention and adherence rates, patients' satisfaction with the home-exercise programme and their progress, affected hand use and acceptance of the intervention). Assessed at baseline, post intervention and 4-week follow-up, secondary outcomes include self-perceived hand and arm use, actual upper extremity function and dexterity, hand strength, independence in activities of daily living and health-related quality of life. Interview data will be analysed using qualitative content analysis. Medians (ranges) will be reported for ordinal data, means (SD) for continuous and frequency (percentage) for nominal data.Ethics and disseminationThis study follows the Standard Protocol Items: Recommendations for Interventional Trials-Patient-Reported Outcome (PRO) Extension guideline. Ethical approval was received from the Ethics Committee of the Medical University of Innsbruck, Austria (1304/2020). Written informed consent will be obtained from all participants prior to data collection. Study results will be disseminated to participating patients, patient organisations, via the clinic's homepage, relevant conferences and peer-reviewed journals.Trial registration numberDRKS-ID: DRKS00023395.Study protocol, second revision, 5 December 2021.

Project description:Post-stroke depression and cognitive impairment are common conditions affecting patients after stroke. Serotonin is a neurotransmitter involved in modulating, among others, mood, cognition, learning, and memory. Sub-optimal serotonin activity may be in part responsible for cognitive deficits seen in depression. In this pilot study serotonin levels were evaluated in 29 patients with sub-acute stroke before and after a rehabilitation treatment (consisting of a program of upper limb robotic rehabilitation in addition to conventional physical therapy treatment). We employed the Back Depression Inventory scale to evaluate symptoms of depression, and specific tools to evaluate cognitive functions. We found a significant reduction of the serotonin levels after rehabilitation in the whole group (T0: 85.9 ± 92.4 ng/mL; T1: 61.9 ± 58.4 ng/mL; p = 0.0018), as well as in the subgroup of patients untreated with Selective Serotonin Reuptake Inhibitors (SRRI), (mean serotonin at T0: 154.0 ± 102.3 ng/mL; mean serotonin at T1: 92.9. ± 68.7 ng/mL at T1; p = 0.005). We also found a correlation with cognitive assessment: in particular, the change from baseline of the serotonin (ΔSerotonin) was correlated with the changes from baseline of the Rey's Figure (ΔROCF) (r = 0.535; p < 0.05), the Tower of London (ΔToL) (subscore point: r = 0.621; p < 0.005; subscore time: r = -0.619; p < 0.005) meaning that a serotonin levels decrease is associated with a worsening of cognitive functions. Considering patients treated and untreated with SSRIs separately, in patients treated with SSRIs (n = 16) we found only a positive correlation between ∆Serotonin and ∆ToL (subscore point: r= 0.587; p = 0.045), whereas in patients untreated with SSRIs (n = 13) we found a positive correlations between ΔSerotonin and ΔROCF (r = 0.700; p = 0.036), ∆Stroop (subscore time: r = 0.750; p = 0.020) and ∆Tol (subscore point: r = 0.740; p = 0.023) and a negative correlation between ΔSerotonin and ∆Tol (subscore time: r= -0.833; p = 0.005). These results suggest that variation of serotonin levels should be monitored in patients during a rehabilitation program, not only for their relationship with depression symptoms, but also for the correlation with cognitive performance.

Project description:ObjectiveTo determine the safety and efficacy of aerobic exercise on activities of daily living in the subacute phase after stroke.DesignMulticentre, randomised controlled, endpoint blinded trial.SettingSeven inpatient rehabilitation sites in Germany (2013-17).Participants200 adults with subacute stroke (days 5-45 after stroke) with a median National Institutes of Health stroke scale (NIHSS, range 0-42 points, higher values indicating more severe strokes) score of 8 (interquartile range 5-12) were randomly assigned (1:1) to aerobic physical fitness training (n=105) or relaxation sessions (n=95, control group) in addition to standard care.InterventionParticipants received either aerobic, bodyweight supported, treadmill based physical fitness training or relaxation sessions, each for 25 minutes, five times weekly for four weeks, in addition to standard rehabilitation therapy. Investigators and endpoint assessors were masked to treatment assignment.Main outcome measuresThe primary outcomes were change in maximal walking speed (m/s) in the 10 m walking test and change in Barthel index scores (range 0-100 points, higher scores indicating less disability) three months after stroke compared with baseline. Safety outcomes were recurrent cardiovascular events, including stroke, hospital readmissions, and death within three months after stroke. Efficacy was tested with analysis of covariance for each primary outcome in the full analysis set. Multiple imputation was used to account for missing values.ResultsCompared with relaxation, aerobic physical fitness training did not result in a significantly higher mean change in maximal walking speed (adjusted treatment effect 0.1 m/s (95% confidence interval 0.0 to 0.2 m/s), P=0.23) or mean change in Barthel index score (0 (-5 to 5), P=0.99) at three months after stroke. A higher rate of serious adverse events was observed in the aerobic group compared with relaxation group (incidence rate ratio 1.81, 95% confidence interval 0.97 to 3.36).ConclusionsAmong moderately to severely affected adults with subacute stroke, aerobic bodyweight supported, treadmill based physical fitness training was not superior to relaxation sessions for maximal walking speed and Barthel index score but did suggest higher rates of adverse events. These results do not appear to support the use of aerobic bodyweight supported fitness training in people with subacute stroke to improve activities of daily living or maximal walking speed and should be considered in future guidelines.Trial registrationClinicalTrials.gov NCT01953549.

Dataset Information

Home-based physical activity incentive and education program in subacute phase of stroke recovery (Ticaa'dom): study protocol for a randomized controlled trial.

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Home-based physical activity incentive and education program in subacute phase of stroke recovery (Ticaa'dom): study protocol for a randomized controlled trial.

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