RecruitingNot ApplicableNCT06525987

Telecoached Exercise Intervention for Connectivity Enhancement in Small Vessel Disease (TELECONNECT-SVD)

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


Sponsor

University of L'Aquila

Enrollment

60 participants

Start Date

May 2, 2025

Study Type

INTERVENTIONAL

Conditions

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 small vessel disease (SVD)-related ischemic stroke. The study will recruit patients aged ≥60 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 encompass changes in physical activity levels, anthropometric measurements, and vital signs. The study employs a "wait list" design, where the control group receives the intervention after the initial 24-week period. This approach allows for assessment of the intervention's immediate effects and the retention of benefits after cessation. Key features of the protocol include: * Use of telecoaching to enhance adherence to the exercise program * Comprehensive assessment of brain connectivity using advanced EEG analysis techniques * Focus on patients with SVD, who may benefit significantly from exercise interventions * Evaluation of both neurophysiological and clinical outcomes The study aims to provide evidence for the potential benefits of exercise in enhancing brain connectivity and physical fitness in SVD patients, potentially informing future treatment guidelines and preventive strategies for this population.


Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called Physical activity for people with lacunar stroke and small vessel cerebrovascular disease. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALPhysical activity

Randomization to a 24-week physical exercise program


Locations(1)

UOC Neurologia e Stroke Unit

Avezzano, L'Aquila, Italy

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NCT06525987


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