Ignite Creation Date:
2024-10-25 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06525987
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
Telecoached Exercise Intervention for Connectivity Enhancement in Small Vessel Disease TELECONNECT-SVD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Telecoached Exercise Intervention for Connectivity Enhancement in Small Vessel Disease TELECONNECT-SVD a Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TELECONNECT
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 11 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 interventions 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
The trial will include 60 participants randomized 11 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 interventions 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None