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โ† Trials
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Telecoached Exercise Intervention for Connectivity Enhancement in Small Vessel Disease (TELECONNECT-SVD)

RecruitingNAAges 60 Years - anyAllUniversity of L'Aquila
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In plain words

What the trial is, and whether it could suit you

The TELECONNECT-SVD study is a prospective, randomized, multicenter trial aimed at testing the efficacy of a remotely delivered exercise protocol on brain functional connectivity in patients with small vessel disease (SVD)-related ischemic stroke. The study will recruit patients aged โ‰ฅ60 with a history of lacunar stroke, minimal disability (modified Rankin Scale score 0-1), and low physical activity levels. The trial will include 60 participants randomized 1:1 to either a 24-week telecoached exercise intervention or usual care. The exercise program consists of multicomponent physical exercises delivered remotely twice a week. Assessments will be conducted at baseline, 12 weeks, 24 weeks, and 48 weeks. Primary outcomes include changes in brain functional connectivity assessed by high-density EEG and improvements in physical fitness measured by the Senior Fitness Test. Secondary outcomes

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ60 years; * History of lacunar stroke occurred between 3 months and 10 years from screening and confirmed by neuroimaging or clinical data by an expert stroke physician; * Modified Rankin Scale (mRS) score of 0-1, indicating no symptoms or no significant disability; * A level of physical activity below recommended targets, i.e. \<150 minutes per week of moderate-to-vigorous exercise (24); * Ability to sign informed consent. Exclusion Criteria: * Uncontrolled hypertension; * Heart disease impairing the possibility of safely following an exercise protocol at the discretion of the treating physician; * Primary or secondary epilepsy; * Prostheses, implants, and any device that might impair the performance of either high-density electroencephalogram or the exercise intervention; * Cognitive impairment (Mini Mental State Examination score โ‰ค26 at follow-up); * Lack of access to Internet-based facilities or poor technological alphabetization impairing the adherence to the trial protocol; * Any major physical or psychiatric comorbidity that in the judgement of the treating physician might compromise the ability to undergo an exercise intervention.
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What it tests

  • Physical activity
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Where

1 site
UOC Neurologia e Stroke Unit
Avezzano, Italy
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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