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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
UOC Neurologia e Stroke Unit
RECRUITING
Avezzano
Contact Information
Primary
Raffaele Ornello, MD, PhD
raffaele.ornello@univaq.it
+390863499322
Time Frame
Start Date: 2025-05-02
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 60
Treatments
Experimental: Immediate intervention
Participants will be allocated to physical activity intervention during the 24 weeks of follow-up.
Other: Delayed intervention
Participants will not be randomized to physical activity intervention during the first 24 weeks of follow-up. They will be randomized after the 24 weeks of follow-up.
Related Therapeutic Areas
Sponsors
Leads: University of L'Aquila
Collaborators: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

This content was sourced from clinicaltrials.gov