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

Telecoached Exercise Intervention for Connectivity Enhancement in Small Vessel Disease (TELECONNECT-SVD): a Randomized Clinical Trial

This program will test whether a 24-week, twice-weekly telecoached exercise plan can improve brain connectivity and physical fitness in people aged 60+ who had a lacunar stroke and are currently not very active.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: University of L'Aquila (Academic / other)
• Locations: 1 site (Avezzano, L'Aquila)
• Trial ID: NCT06525987 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are people aged 60 or older with a lacunar stroke 3 months to 10 years ago, minimal residual disability (mRS 0–1), and under 150 minutes/week of moderate-to-vigorous activity.

Not a fit: Those with uncontrolled hypertension, heart conditions that preclude safe exercise, epilepsy, cognitive impairment, implants that interfere with EEG or exercise, or no reliable internet access may not benefit or may be ineligible.

Why it matters

Potential benefit: If successful, the intervention could improve brain network function and physical fitness after lacunar stroke, potentially reducing long-term disability risk.

How similar studies have performed: Prior exercise programs after stroke have improved fitness and some cognitive or functional outcomes, but telecoached interventions specifically targeting high-density EEG functional connectivity in small vessel disease are relatively novel and not yet well established.

Eligibility criteria

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 this trial is running

Avezzano, L'Aquila

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

Study contacts

• Study coordinator: Raffaele Ornello, MD, PhD

Conditions Lacunar Stroke; Small Vessel Cerebrovascular Disease