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

NCT ID: NCT06525987

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-02
• Study Completion Date: 2026-12-31

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 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.

Conditions

Lacunar Stroke; Small Vessel Cerebrovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Immediate intervention

Participants will be allocated to physical activity intervention during the 24 weeks of follow-up.

Group Type: EXPERIMENTAL

Physical activity

Intervention Type: BEHAVIORAL

Randomization to a 24-week physical exercise program

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.

Group Type: OTHER

Physical activity

Intervention Type: BEHAVIORAL

Randomization to a 24-week physical exercise program

Interventions

Physical activity

Randomization to a 24-week physical exercise program

Intervention Type: BEHAVIORAL

Other Intervention Names

Physical activity (delayed)

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: collaborator

University of L'Aquila

OTHER

Sponsor Role: lead

Responsible Party

Simona Sacco

Full Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UOC Neurologia e Stroke Unit

Avezzano, L'Aquila, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Raffaele Ornello, MD, PhD

Role: CONTACT

raffaele.ornello@univaq.it

+390863499322

Facility Contacts

Raffaele Ornello, MD, PhD

Role: primary

raffaele.ornello@univaq.it

+390863499322

Other Identifiers

Not yet determined

Identifier Type: -

Identifier Source: org_study_id