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| Name | Class |
|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate intervention | Experimental | Participants will be allocated to physical activity intervention during the 24 weeks of follow-up. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical activity | Behavioral | Randomization to a 24-week physical exercise program |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in brain functional connectivity | Overall brain functional connectivity in the resting state assessed via high-density electroencephalogram | 24 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raffaele Ornello, MD, PhD | Contact | +390863499322 | raffaele.ornello@univaq.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UOC Neurologia e Stroke Unit | Recruiting | Avezzano | L'Aquila | 67051 | Italy |
IPD will be available from the central contact person upon reasonable request.
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| ID | Term |
|---|---|
| D059409 | Stroke, Lacunar |
| D059345 | Cerebral Small Vessel Diseases |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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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.
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Outcomes will be assessed by investigators blinded to participants' allocation.
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 |
| D000083244 | Thrombotic Stroke |
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020520 | Brain Infarction |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |