Telecoached Exercise Intervention for Connectivity Enhancement in Small Vessel Disease (TELECONNECT-SVD)
NCT Number: NCT06525987
Acronym: TELECONNECT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lacunar Stroke|Small Vessel Cerebrovascular Disease
Interventions: BEHAVIORAL: Physical activity
Sponsor: University of L'Aquila
Collaborators: Policlinico Universitario "A. Gemelli" - Rome
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2026-11-30

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.

Primary Outcome Measures: 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: 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: Change in brain functional connectivity, Overall brain functional connectivity in the resting state assessed via high-density electroencephalogram, 24 weeks