Telecoached Exercise Intervention for Connectivity Enhancement in Small Vessel Disease (TELECONNECT-SVD): a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Senior Fitness Test score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes will be assessed by investigators blinded to participants' allocation.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in Senior Fitness Test score
时间窗: 24 weeks
Change in the Senior Fitness score from before to after the 24-week physical exercise intervention
次要结局
- Change in Body Mass Index(24 weeks)
- Change in heart rate(24 weeks)
- Change in International Physical Activity Questionnaire (IPAQ) score(24 weeks)
- Change in blood pressure(24 weeks)
研究者
Simona Sacco
Full Professor of Neurology
University of L'Aquila