Effects of Combined Therapies of Physical Exercise, Mindfulness and Cognitive Stimulation on Cognition and Neuroplasticity in Chronic Stroke Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- Change in verbal memory after receiving treatment
研究概览
简要总结
The main objective of MindFit Project is to develop an evidence-based multimodal investigation of combined non-pharmacological strategies in chronic stroke patients and clarify the neuroplasticity mechanisms underlying the benefits of physical exercise and mindfulness strategies combined with cognitive training on post-stroke recovery. The investigators have adopted a multidisciplinary and multimodal approach to provide a more integrative perspective using cognitive, social-psychological, biochemical, and neuroimaging measurements.
详细描述
The MindFit Project is a multicentric, prospective, parallel, single-blinded, randomized controlled trial with a sample of 141 participants at 3 to 60 months after stroke. Participants are randomly allocated to one of three arms (through a simple randomizing procedure with a 1:1:1 ratio created with a random sequence generator software).
The first group (n=47) receives computer-based cognitive training (CCT) combined with a multicomponent physical exercise program. The second group (n=47) receives CCT combined with mindfulness-based stress reduction therapy. Finally, the third group (n=47), as an active control group, receives only CCT. All interventions last 12 weeks.
Within two weeks before the start of the interventions, and again at 3 months after completing the interventions, medical, cognitive, and physical assessments, neuroimaging, and biological samples collection are performed.
The objectives of this project are:
- To examine the effects of multimodal interventions in a population of chronic stroke patients on various domains: cognition, emotion, physical health, and quality of life.
- To examine specific plasticity effects of each of the three interventions regarding structural and functional magnetic resonance imaging (MRI) and how these changes may contribute to cognitive and emotional benefits.
- To study the molecular mechanisms by which the different types of interventions influence cognitive, emotional and brain benefits.
- To study interventions-induced microbiome changes and to explain how these changes may induce inflammatory and immune responses that may contribute to cognitive, emotional and brain benefits.
- To determine the demographic, clinical and genetic factors that may modulate cognitive, emotional and brain changes: baseline cognitive status; baseline cerebral status (atrophy, total intracranial volume); sex; age, educational level, intelligence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The randomization sequence is concealed (blinded) from research personnel, so that the investigators are not aware of whether a particular subject has been randomized to one of the intervention groups or to the active control group.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 18-80 years old
- •Ischemic or hemorrhagic stroke
- •Stroke diagnoses between 3-60 months ago
- •To have consent from a physician to engage in an exercise intervention
- •Fluency in Catalan or Spanish (I.e., able to understand and speak)
- •Accept to take part in the study and sign the informed consent according to the Declaration of Helsinki.
排除标准
- •Cognitive impairment (MMSE > 23)
- •Severe aphasia (item 9 of the NIHSS scale ≥ 2)
- •Severe sensory problems
- •Other neurological conditions apart from stroke
- •Severe pre-stroke psychiatric disorders (e.g., bipolar disorder, schizophrenia)
- •History of alcohol or other toxic abuse
- •Exclusion criteria only for MRI examination:
- •Claustrophobia
- •Medical device (e.g., pacemaker implants, stents)
- •Other metal objects in the body
结局指标
主要结局
Change in verbal memory after receiving treatment
时间窗: 3 months (at baseline, 3 months from baseline)
Rey Auditory Learning Test
Change in executive function, inhibition after receiving treatment
时间窗: 3 months (at baseline, 3 months from baseline)
Stroop Test
Change in executive function, set-switching task after receiving treatment
时间窗: 3 months (at baseline, 3 months from baseline)
Trail Making Test
Change in immediate verbal attention after receiving treatment
时间窗: 3 months (at baseline, 3 months from baseline)
Forward Digit Span (WAIS III)
Change in verbal digit working memory after receiving treatment
时间窗: 3 months (at baseline, 3 months from baseline)
Backward Digit Span (WAIS III)
Change in executive function, verbal fluency after receiving treatment
时间窗: 3 months (at baseline, 3 months from baseline)
Phonetic Fluency is measured using the Controlled Oral Word Association Test, spanish adaptation, and semantic fluency test using the category Animal
Change in visual memory after receiving treatment
时间窗: 3 months (at baseline, 3 months from baseline)
Rey's Complex Figure Test
Change in language, naming after receiving treatment
时间窗: 3 months (at baseline, 3 months from baseline)
Boston naming Test
次要结局
- Changes in wellbeing(3 months (at baseline, 3 months from baseline))
- Changes in Resting-state connectivity(3 months (at baseline, 3 months from baseline))
- Changes in psychological distress(3 months (at baseline, 3 months from baseline))
- Changes in depression and anxiety(3 months (at baseline, 3 months from baseline))
- Changes in Fitness(3 months (at baseline, 3 months from baseline))
- Changes in Mindfulness(3 months (at baseline, 3 months from baseline))
- Changes in White matter integrity(3 months (at baseline, 3 months from baseline))
- Changes in brain volumetry(3 months (at baseline, 3 months from baseline))
- Changes in Microbiota data(3 months (at baseline, 3 months from baseline))
- Changes in physical activity:(3 months (at baseline, 3 months from baseline))
- Molecular changes: growth factors (BDNF, SDF1-a, VEGF-A, IGF-1, and NGF), cortisol, protein C reactive, IL-6 and homocysteine levels(3 months (at baseline, 3 months from baseline))
- Changes in Sleep(3 months (at baseline, 3 months from baseline))
- Changes in stroke specific quality of life(3 months (at baseline, 3 months from baseline))
- Changes in quality of life(3 months (at baseline, 3 months from baseline))
- Changes in mental fatigue(3 months (at baseline, 3 months from baseline))
研究者
Maria Mataro Serrat
Professor
University of Barcelona