Lacunar StrokeTELECONNECTNCT06525987
Telecoached Exercise Intervention for Connectivity Enhancement in Small Vessel Disease (TELECONNECT-SVD)
A study testing Physical activity in people with Lacunar Stroke and Small Vessel Cerebrovascular Disease, run by University of L'Aquila at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Lacunar Stroke, Small Vessel Cerebrovascular Disease
- What is being tested?
- Physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 2 May 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
UOC Neurologia e Stroke Unit
Avezzano, L'Aquila, 67051
Raffaele Ornello, MD, PhD, +390863499322, raffaele.ornello@univaq.it
About this study
Official title: 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.
Read more
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.
- Being tested
- Physical activity
- Medical subject headings
- Stroke, Lacunar, Cerebral Small Vessel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
Also called Physical activity (delayed)
Randomization to a 24-week physical exercise program
| Study group | Role | What they receive |
|---|---|---|
| Immediate intervention | Experimental | Participants will be allocated to physical activity intervention during the 24 weeks of follow-up. Receives: Behavioral: Physical activity |
| 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. Receives: Behavioral: Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Senior Fitness Test score
Change in the Senior Fitness score from before to after the 24-week physical exercise intervention
Measured: 24 weeks
Secondary outcomes (4)
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
Measured: 24 weeks
Change in Body Mass Index
Change in Body Mass Index score from before to after the 24-week physical exercise intervention
Measured: 24 weeks
Change in blood pressure
Change in blood pressure from before to after the 24-week physical exercise intervention
Measured: 24 weeks
Change in heart rate
Change in heart rate from before to after the 24-week physical exercise intervention
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start2 May 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lacunar StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of L'Aquila
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simona Sacco, University of L'Aquila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525987
- Sponsor's protocol ID
- Not yet determined
- Acronym
- TELECONNECT
- Status last verified
- Nov 2025
- First submitted
- 23 Jul 2024
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be available from the central contact person upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telecoached Exercise Intervention for Connectivity Enhancement in Small Vessel Disease (TELECONNECT-SVD): a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06525987
- Acronym / sponsor ID
- TELECONNECT / Not yet determined
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of L'AquilaUniversity, hospital or other
- Collaborators
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study start
- 2 May 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Immediate intervention | Experimental | Behavioral: Physical activityParticipants will be allocated to physical activity intervention during the 24 weeks of follow-up. |
| Delayed intervention | Other | Behavioral: Physical activityParticipants 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activityAlso: Physical activity (delayed)Randomization to a 24-week physical exercise program | Behavioural | Delayed intervention, Immediate intervention |
Primary outcome
Change in Senior Fitness Test score
Time frame: 24 weeks
Change in the Senior Fitness score from before to after the 24-week physical exercise intervention
4 secondary outcomes
Change in International Physical Activity Questionnaire (IPAQ) score
Time frame: 24 weeks
Change in Body Mass Index
Time frame: 24 weeks
Change in blood pressure
Time frame: 24 weeks
Change in heart rate
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No. IPD will be available from the central contact person upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with Lacunar Stroke and Small Vessel Cerebrovascular Disease, run by University of L'Aquila at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raffaele Ornello, MD, PhD (+390863499322, raffaele.ornello@univaq.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Senior Fitness Test score (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.