Telecoached exercise program to boost brain connectivity after small vessel (lacunar) stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

TELECONNECT-SVD is a prospective, randomized, multicenter trial that will enroll 60 participants aged 60 or older with a prior lacunar stroke and low physical activity. Participants will be randomized 1:1 to a 24-week multicomponent exercise program delivered remotely twice weekly or to usual care, with outcome visits at baseline, 12, 24, and 48 weeks. The primary outcome is change in brain functional connectivity measured by high-density EEG, together with change in physical fitness measured by the Senior Fitness Test; secondary outcomes include activity levels, anthropometrics, and vital signs. The protocol excludes patients with uncontrolled hypertension, significant cardiac limitations, epilepsy, certain implants that interfere with EEG or exercise, cognitive impairment, or lack of reliable internet access.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥60 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 ≤26 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.

Where it's running

• UOC Neurologia e Stroke Unit
  Avezzano, L'Aquila, Italy Recruiting

Study contacts

• Study coordinator: Raffaele Ornello, MD, PhD
• Email: raffaele.ornello@univaq.it
• Phone: +390863499322

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.