NCT06525987 Telecoached Exercise Intervention for Connectivity Enhancement in Small Vessel Disease (TELECONNECT-SVD)
| NCT ID | NCT06525987 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of L'Aquila |
| Condition | Lacunar Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-05-02 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-05-02 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06525987 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Lacunar Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06525987 currently recruiting?
Yes, NCT06525987 is actively recruiting participants. Contact the research team at raffaele.ornello@univaq.it for enrollment information.
Where is the NCT06525987 trial being conducted?
This trial is being conducted at Avezzano, Italy.
Who is sponsoring the NCT06525987 clinical trial?
NCT06525987 is sponsored by University of L'Aquila. The trial plans to enroll 60 participants.
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