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

NCT06525987 | Recruiting

• 1 other identifier: Not yet determined
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Senior Fitness Test score

  Change in the Senior Fitness score from before to after the 24-week physical exercise intervention

  24 weeks

Secondary Outcomes (4)

• Change in International Physical Activity Questionnaire (IPAQ) score

  24 weeks

• Change in Body Mass Index

  24 weeks

• Change in blood pressure

  24 weeks

• Change in heart rate

  24 weeks

Other Outcomes (1)

• Change in brain functional connectivity

  24 weeks

Study Arms (2)

Immediate intervention

EXPERIMENTAL

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

Behavioral: Physical activity

Delayed intervention

OTHER

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.

Behavioral: Physical activity

Interventions

Physical activity BEHAVIORAL

Randomization to a 24-week physical exercise program

Also known as: Physical activity (delayed)

Delayed intervention; Immediate intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of L'Aquila: lead
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: collaborator

Study Sites (1)

UOC Neurologia e Stroke Unit

Avezzano, L'Aquila, 67051, Italy

RECRUITING

MeSH Terms

Conditions

Stroke, Lacunar; Cerebral Small Vessel Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Thrombotic Stroke; Ischemic Stroke; Stroke; Vascular Diseases; Cardiovascular Diseases; Brain Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Raffaele Ornello, MD, PhD

CONTACT

+390863499322; raffaele.ornello@univaq.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes will be assessed by investigators blinded to participants' allocation.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Neurology

Model Details: The trial will adopt a "wait list" delish in which one group will be randomized to immediate intervention while the other group will be randomized to delayed intervention.

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: July 29, 2024
• Study Start: May 2, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)