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Impact of physical activity in vascular cognitive impairment (AFIVASC): study protocol for a randomised controlled trial.

ABSTRACT: BACKGROUND:Cognitive impairment and cerebrovascular pathology are both frequent with ageing. Cognitive impairment due to vascular pathology of the brain, termed vascular cognitive impairment (VCI), is one of the most frequent causes of cognitive impairment in elderly subjects. Thus far, VCI has no specific pharmacological treatment. Recent observational studies have suggested a protective effect of physical activity in cognition, but adequate randomised controlled trials (RCT) are lacking. METHODS:AFIVASC is a multi-centre randomised controlled trial, with a 6-month intervention treatment and an additional follow-up of 6 months, that aims to estimate the impact of 6 months of moderate intensity physical activity on cognition (the primary outcome) at 6 and 12?months in subjects with VCI. Participants are community dwellers with criteria for VCI without dementia or who have had previous stroke or transient ischaemic attack (TIA). Patients may be self-referred or referred from a medical appointment. After confirming the inclusion criteria, a run-in period of 1?month is conducted to access adherence; only after that are subjects randomly assigned (using a computerised program blinded to clinical details) to two groups (intervention group and best practice usual care group). The intervention consists of three physical activity sessions of 60?min each (two supervised and one unsupervised) per week. The primary outcome is measured by the presence or absence of decline in cognitive status. Secondary outcomes include changes in neuro-cognitive measures, quality of life, and functional and motor status. Primary and secondary outcomes are evaluated at 6 and 12?months by investigators blinded to both intervention and randomisation. A required sample size of 280 subjects was estimated. Statistical analyses will include regression analysis with repeated measures. The study was approved by the Ethics Committee for Health of Centro Hospitalar de Lisboa Norte (ref. no. 1063/13) and by the Ethics Committee for Health of Centro Hospitalar do Porto CHP (ref. no. 2016.055(049-DEFI/048-CES)). DISCUSSION:We aim to show whether or not moderate physical activity has a beneficial impact on cognition, quality of life, motor, and functional status in people with vascular cognitive impairment, and to generate new insights on the applicability of implementing physical activity in this specific population. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03578614 July 6, 2018.

SUBMITTER: Verdelho A

PROVIDER: S-EPMC6371566 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Impact of physical activity in vascular cognitive impairment (AFIVASC): study protocol for a randomised controlled trial.

Verdelho Ana A Madureira Sofia S Correia Manuel M Ferro José Manuel JM Rodrigues Mário M Gonçalves-Pereira Manuel M Gonçalves Mafalda M Santos Ana Catarina AC Vilela Pedro P Bárrios Helena H Borges Mariana M Santa-Clara Helena H

Trials 20190211 1

<h4>Background</h4>Cognitive impairment and cerebrovascular pathology are both frequent with ageing. Cognitive impairment due to vascular pathology of the brain, termed vascular cognitive impairment (VCI), is one of the most frequent causes of cognitive impairment in elderly subjects. Thus far, VCI has no specific pharmacological treatment. Recent observational studies have suggested a protective effect of physical activity in cognition, but adequate randomised controlled trials (RCT) are lackin ...[more]

PMID: 30744681

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Project description:IntroductionBeing physically active is associated with a wide range of health benefits in patients. However, many patients do not engage in the recommended levels of physical activity (PA). To date, interventions promoting PA in patients mainly rely on providing knowledge about the benefits associated with PA to develop their motivation to be active. Yet, these interventions focusing on changing patients' conscious goals have proven to be rather ineffective in changing behaviours. Recent research on automatic factors (eg, automatic approach tendencies) may provide additional targets for interventions. However, the implementation and evaluation of intervention designed to change these automatic bases of PA are rare. Consequently, little is known about whether and how interventions that target automatically activated processes towards PA can be effective in changing PA behaviours. The Improving Physical Activity (IMPACT) trial proposes to fill this knowledge gap by investigating the effect of a cognitive-bias modification intervention aiming to modify the automatic approach towards exercise-related stimuli on PA among patients.Methods and analysisThe IMPACT trial is a single-centre, placebo (sham controlled), triple-blinded, phase 3 randomised controlled trial that will recruit 308 patients enrolled in a rehabilitation programme in the Division of General Medical Rehabilitation at the University Hospital of Geneva (Switzerland) and intends to follow up them for up to 1 year after intervention. Immediately after starting a rehabilitation programme, patients will be randomised (1:1 ratio) to receive either the cognitive-bias modification intervention consisting of a 12-session training programme performed over 3 weeks or a control condition (placebo). The cognitive-bias modification intervention aims to improve PA levels through a change in automatic approach tendencies towards PA and sedentary behaviours. The primary outcome is the sum of accelerometer-based time spent in light-intensity, moderate-intensity and vigorous-intensity PA over 1 week after the cognitive-bias modification intervention (in minutes per week). Secondary outcomes are related to changes in (1) automatic approach tendencies and self-reported motivation to be active, (2) physical health and (3) mental health. Sedentary behaviours and self-reported PA will also be examined. The main time point of the analysis will be the week after the end of the intervention. These outcomes will also be assessed during the rehabilitation programme, as well as 1, 3, 6 and 12 months after the intervention for secondary analyses.Ethics and disseminationThe study will be conducted in accordance with the Declaration of Helsinki. This trial was approved by the Ethics Committee of Geneva Canton, Switzerland (reference number: CCER2019-02257). All participants will give an informed consent to participate in the study. Results will be published in relevant scientific journals and be disseminated in international conferences.Trial registration detailsThe clinical trial was registered at the German clinical trials register (reference number: DRKS00023617); Pre-results.

Project description:BackgroundFrail older adults have reduced functional and physiological reserves, rendering them more vulnerable to the effects of hospitalization, which frequently results in failure to recover from the pre-hospitalization functional loss, new disability or even continued functional decline. Alternative care models with an emphasis on multidisciplinary and continuing care units are currently being developed. Their main objective, other than the recovery of the condition that caused admission, is the prevention of functional decline. Many studies on functional decline have discussed the available evidence regarding the effectiveness of acute geriatric units. Despite the theoretical support for the idea that mobility improvement in the hospitalized patient carries multiple benefits, this idea has not been fully translated into clinical practice.Methods/designThis study is a randomized clinical trial conducted in the Department of Geriatrics of a tertiary public hospital with 35 beds allocated. Hospitalized patients who meet the inclusion criteria will be randomly assigned to the intervention or control group. The intervention will consist of a multicomponent exercise training programme, which will be composed of supervised progressive resistance exercise training, balance-training, and walking for 5-7 consecutive days. During the training period, patients will be trained in 20 min sessions twice a day (morning and evening).DiscussionFunctional and cognitive impairment after and during acute hospitalization in older adults is a major determinant of the later need for health resources. If our hypothesis is correct and shows that a multicomponent, individualized and progressive exercise programme provides effective therapy for improving the functional capacity of acute elderly patients hospitalized for medical pathology versus conventional care, a change of the current system of hospitalization of elderly patients with medical conditions may be justified.Trial registrationClinicalTrials.gov Identifier: NCT02300896 (Date of registration 19 November 2014).

Project description:ObjectiveTo assess the efficacy of a progressive aerobic exercise training program on cognitive and everyday function among adults with mild subcortical ischemic vascular cognitive impairment (SIVCI).MethodsThis was a proof-of-concept single-blind randomized controlled trial comparing a 6-month, thrice-weekly, progressive aerobic exercise training program (AT) with usual care plus education on cognitive and everyday function with a follow-up assessment 6 months after the formal cessation of aerobic exercise training. Primary outcomes assessed were general cognitive function (Alzheimer's Disease Assessment Scale-Cognitive subscale [ADAS-Cog]), executive functions (Executive Interview [EXIT-25]), and activities of daily living (Alzheimer's Disease Cooperative Study-Activities of Daily Living [ADCS-ADL]).ResultsSeventy adults randomized to aerobic exercise training or usual care were included in intention-to-treat analyses (mean age 74 years, 51% female, n = 35 per group). At the end of the intervention, the aerobic exercise training group had significantly improved ADAS-Cog performance compared with the usual care plus education group (-1.71 point difference, 95% confidence interval [CI] -3.15 to -0.26, p = 0.02); however, this difference was not significant at the 6-month follow-up (-0.63 point difference, 95% CI -2.34 to 1.07, p = 0.46). There were no significant between-group differences at intervention completion and at the 6-month follow-up in EXIT-25 or ADCS-ADL performance. Examination of secondary measures showed between-group differences at intervention completion favoring the AT group in 6-minute walk distance (30.35 meter difference, 95% CI 5.82 to 54.86, p = 0.02) and in diastolic blood pressure (-6.89 mm Hg difference, 95% CI -12.52 to -1.26, p = 0.02).ConclusionsThis study provides preliminary evidence for the efficacy of 6 months of thrice-weekly progressive aerobic training in community-dwelling adults with mild SIVCI, relative to usual care plus education.Clinicaltrialsgov identifierNCT01027858.Classification of evidenceThis study provides Class II evidence that for adults with mild SIVCI, an aerobic exercise program for 6 months results in a small, significant improvement in ADAS-Cog performance.

Project description:IntroductionPhysical inactivity and excessive sedentary behaviours are major preventable causes in both the development and the treatment of obesity and type 2 diabetes mellitus (T2DM). Nevertheless, current programmes struggle to engage and sustain physical activity (PA) of patients over long periods of time. To overcome these limitations, the Digital Intervention Promoting Physical Activity among Obese people randomised controlled trial (RCT) aims to evaluate the effectiveness of a group-based digital intervention grounded on gamification strategies, enhanced by social features and informed by the tenets of the self-determination theory and the social identity approach.Methods and analysisThis trial is a two-arm parallel RCT testing the effectiveness of the Kiplin digital intervention on obese and patients with T2DM in comparison to the usual supervised PA programme of the University Hospital of Clermont-Ferrand, France. A total of 50 patients will be randomised to one of the two interventions and will follow a 3-month programme with a 6-month follow-up postintervention. The primary outcome of the study is the daily step count change between the baseline assessment and the end of the intervention. Accelerometer data, self-reported PA, body composition and physical capacities will also be evaluated. To advance our understanding of complex interventions like gamified and group-based ones, we will explore several psychological mediators relative to motivation, enjoyment, in-group identification or perceived weight stigma. Finally, to assess a potential superior economic efficiency compared with the current treatment, we will conduct a cost-utility analysis between the two conditions. A mixed-model approach will be used to analyse the change in outcomes over time.Ethics and disseminationThe research protocol has been reviewed and approved by the Local Human Protection Committee (CPP Ile de France XI, No 21 004-65219). Results will inform the Kiplin app development, be published in scientific journals and disseminated in international conferences.Trial registration numberNCT04887077.

Project description:INTRODUCTION:Mild cognitive impairment (MCI) is common in older adults and represents a high-risk group for progression to Alzheimer's disease (AD). Medication trials in MCI have generally failed, but new discoveries with brain plasticity in ageing have led to the study of cognitive training as a potential treatment to improve cognitive abilities. Computerised cognitive training (CCT) involves computerised cognitive exercises that target specific cognitive abilities and neural networks to potentially improve cognitive functioning through neuroplasticity. METHODS AND ANALYSIS:In a two-site study (New York State Psychiatric Institute/Columbia University Medical Center and Duke University Medical Center), we will randomise 100 patients with MCI (Wechsler Memory Scale-III Logical Memory II score 0-11; Folstein Mini Mental State Examination ?23) to home-based CCT (suite of exercises: memory, matching, spatial recognition, processing speed) or a home-based active control condition (computerised crossword puzzle training (CPT)) with 12 weeks of intensive training followed by regular booster sessions up to 78 weeks. All patients will receive standard neuropsychological and functional assessments in clinic as well as structural/functional brain MRI scans at study entry and endpoint. We will test if CCT, versus CPT, leads to improved cognitive functioning, transfers to functional ability and tasks of everyday life and impacts hippocampal volume changes and changes in the default mode network of the brain measured by resting-state functional MRI. ETHICS AND DISSEMINATION:The study will be conducted following ethics approval and written informed consent will be obtained from all subjects. Study results will be disseminated via publication, clinicaltrials.gov, media and conference presentations. This will be the first controlled long-term trial to evaluate the effects of home-based CCT versus computerised CPT on cognitive abilities and functional measures and neural outcomes as determined by MRI indices in patients with MCI. Positive results from trial may support further development of home-based CCT. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov identifier (NCT03205709).

Project description:IntroductionCerebral small vessel disease (cSVD) accounts for 20%-25% of strokes and is the most common cause of vascular cognitive impairment (VCI). In an animal VCI model, inducing brief periods of limb ischaemia-reperfusion reduces subsequent ischaemic brain injury with remote and local protective effects, with hindlimb remote ischaemic conditioning (RIC) improving cerebral blood flow, decreasing white-matter injury and improving cognition. Small human trials suggest RIC is safe and may prevent recurrent strokes. It remains unclear what doses of chronic daily RIC are tolerable and safe, whether effects persist after treatment cessation, and what parameters are optimal for treatment response.Methods and analysisThis prospective, open-label, randomised controlled trial (RCT) with blinded end point assessment and run-in period, will recruit 24 participants, randomised to one of two RIC intensity groups: one arm treated once daily or one arm twice daily for 30 consecutive days. RIC will consistent of 4 cycles of blood pressure cuff inflation to 200 mm Hg for 5 min followed by 5 min deflation (total 35 min). Selection criteria include: age 60-85 years, evidence of cSVD on brain CT/MRI, Montreal Cognitive Assessment (MoCA) score 13-24 and preserved basic activities of living. Outcomes will be assessed at 30 days and 90 days (60 days after ceasing treatment). The primary outcome is adherence (completing ≥80% of sessions). Secondary safety/tolerability outcomes include the per cent of sessions completed and pain/discomfort scores from patient diaries. Efficacy outcomes include changes in cerebral blood flow (per arterial spin-label MRI), white-matter hyperintensity volume, diffusion tensor imaging, MoCA and Trail-Making tests.Ethics and disseminationResearch Ethics Board approval has been obtained. The results will provide information on feasibility, dose, adherence, tolerability and outcome measures that will help design a phase IIb RCT of RIC, with the potential to prevent VCI. Results will be disseminated through peer-reviewed publications, organisations and meetings.Trial registration numberNCT04109963.

Project description:BackgroundAs life expectancy increases and the number of older people, particularly those aged 85 years and over, expands there is an increase in demand for long-term care. A large proportion of people in a care home setting spend most of their time sedentary, and this is one of the leading preventable causes of death. Encouraging residents to engage in more physical activity could deliver benefits in terms of physical and psychological health, and quality of life. This study is the final stage of a programme of research to develop and preliminarily test an evidence-based intervention designed to enhance opportunities for movement amongst care home residents, thereby increasing levels of physical activity.Methods/designThis is a cluster randomised feasibility trial, aiming to recruit at least 8-12 residents at each of 12 residential care homes across Yorkshire, UK. Care homes will be randomly allocated on a 1:1 basis to receive either the intervention alongside usual care, or to continue to provide usual care alone. Assessment will be undertaken with participating residents at baseline (prior to care home randomisation) and at 3, 6, and 9 months post-randomisation. Data relating to changes in physical activity, physical function, level of cognitive impairment, mood, perceived health and wellbeing, and quality of life will be collected. Data at the level of the home will also be collected and will include staff experience of care, and changes in the numbers and types of adverse events residents experience (for example, hospital admissions, falls). Details of National Health Service (NHS) usage will be collected to inform the economic analysis. An embedded process evaluation will obtain information to test out the theory of change underpinning the intervention and its acceptability to staff and residents.DiscussionThis feasibility trial with embedded process evaluation and collection of health economic data will allow us to undertake detailed feasibility work to inform a future large-scale trial. It will provide valuable information to inform research procedures in this important but challenging area.Trial registrationISRCTN registry, ISRCTN16076575 . Registered on 25 June 2015.

Dataset Information

Impact of physical activity in vascular cognitive impairment (AFIVASC): study protocol for a randomised controlled trial.

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Impact of physical activity in vascular cognitive impairment (AFIVASC): study protocol for a randomised controlled trial.

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