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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Small Vessel Cerebrovascular Disease; Lacunar Stroke
• Intervention / Treatment: Behavioral: Physical activity

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Raffaele Ornello, MD, PhD; Phone Number: +390863499322; Email: raffaele.ornello@univaq.it

Study Locations

• Italy
  • L'Aquila
    • Avezzano, L'Aquila, Italy, 67051
      • Recruiting
      • UOC Neurologia e Stroke Unit
      • Contact: Raffaele Ornello, MD, PhD; Phone Number: +390863499322; Email: raffaele.ornello@univaq.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate intervention; Participants will be allocated to physical activity intervention during the 24 weeks of follow-up.	Behavioral: Physical activity; Randomization to a 24-week physical exercise program; Other Names: Physical activity (delayed)
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.	Behavioral: Physical activity; Randomization to a 24-week physical exercise program; Other Names: Physical activity (delayed)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in International Physical Activity Questionnaire (IPAQ) score	Change in International Physical Activity Questionnaire (IPAQ) score from before to after the 24-week physical exercise intervention	24 weeks
Change in Body Mass Index	Change in Body Mass Index score from before to after the 24-week physical exercise intervention	24 weeks
Change in blood pressure	Change in blood pressure from before to after the 24-week physical exercise intervention	24 weeks
Change in heart rate	Change in heart rate from before to after the 24-week physical exercise intervention	24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in brain functional connectivity	Overall brain functional connectivity in the resting state assessed via high-density electroencephalogram	24 weeks

Collaborators and Investigators

• Sponsor: University of L'Aquila
• Collaborators: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 23, 2024
• First Submitted That Met QC Criteria: July 23, 2024
• First Posted (Actual): July 29, 2024

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Thrombotic Stroke; Ischemic Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Brain Infarction; Infarction; Necrosis; Ischemia; Stroke; Pathological Conditions, Signs and Symptoms; Cerebral Small Vessel Diseases; Stroke, Lacunar; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: Not yet determined

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will be available from the central contact person upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No