Clinical trial NCT06525987: Telecoached Exercise Intervention for Connectivity Enhancement in Small Vessel Disease (TELECONNECT-SVD)
Official title: Telecoached Exercise Intervention for Connectivity Enhancement in Small Vessel Disease (TELECONNECT-SVD): a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lacunar Stroke
Small Vessel Cerebrovascular Disease
Lead sponsor: University of L'Aquila
Sponsor class: OTHER
Collaborators: name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
First posted: 2024-07-29
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in Senior Fitness Test score
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in International Physical Activity Questionnaire (IPAQ) score
timeFrame: 24 weeks
measure: Change in Body Mass Index
timeFrame: 24 weeks
measure: Change in blood pressure
timeFrame: 24 weeks
measure: Change in heart rate
timeFrame: 24 weeks
Other outcomes:
measure: Change in brain functional connectivity
timeFrame: 24 weeks
Locations:
Study officials:
References: