Status:
RECRUITING
Telecoached Exercise Intervention for Connectivity Enhancement in Small Vessel Disease (TELECONNECT-SVD)
Lead Sponsor:
University of L'Aquila
Collaborating Sponsors:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Lacunar Stroke
Small Vessel Cerebrovascular Disease
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
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 smal...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06525987
Start Date
May 2 2025
End Date
December 31 2026
Last Update
December 2 2025
Active Locations (1)
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1
UOC Neurologia e Stroke Unit
Avezzano, L'Aquila, Italy, 67051