Effects and Mechanism of Two Hybrid Exercise-cognitive Trainings in Mild Ischemic Stroke With Cognitive Decline
Condition: Stroke Patients With Cognitive Decline
MeSH terms: Stroke; Ischemic Stroke; Cognitive Dysfunction
Study type: Interventional

Summary: 
      The purposes are to: (1) examine and compare the effects of two hybrid interventions on brain
      plasticity, physiological biomarkers and behavioral outcomes, including cognitive and
      physical functions, from pre- to post-training; (2) understand the neural mechanisms of
      cognitive recovery following two hybrid interventions using the functional magnetic resonance
      imaging (fMRI); (3) examine the long-term benefits of the two hybrid therapies; (4) to
      identify the correlations between brain activity, biomarkers and behavioral measures.
    

Detailed description: 
      Cognitive decline after stroke is highly associated with functional disability. Empirical
      evidence shows that exercise combined cognitive training may induce neuroplastic changes that
      modulate cognitive function. However, it is unclear whether hybridized exercise-cognitive
      trainings can facilitate cortical activity and physiological outcome measures and further
      influence on the cognitive function after stroke. We aim to investigate the effects of two
      hybridized exercise-cognitive trainings on brain plasticity, physiological biomarkers and
      behavioral outcomes in stroke survivors with cognitive decline. This study is a single-blind
      randomized controlled trial. A target sample size of 75 participants will be recruited.
      Stroke survivors with mild cognitive decline will be stratified by Mini-Mental State
      Examination scores and then randomized 1:1:1 to sequential exercise-cognitive training,
      dual-task exercise-cognitive training or control groups. All groups will undergo trainings 60
      min/day, 3 days/week, for a total of 12 weeks. The primary outcome is the resting-state
      functional connectivity and neural activation in the frontal, parietal and occipital lobes in
      functional magnetic resonance imaging. Secondary outcomes include physiological biomarkers,
      cognitive functions, physical function, daily functions and quality of life.

      This study may differentiate the effects of two hybridized trainings on cognitive function
      and health-related conditions and detect appropriate neurological and physiological indices
      to predict training effects. This study capitalizes on the groundwork for non-pharmacological
      intervention of cognitive decline after stroke.
    

Intervention name(s): Sequential training; Dual training; Control training
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The participant will cycle on a stationary bike for 30 minutes, which includes a 3-min warm-up phase followed by the aerobic training components (25 minutes), then a 2-min cool-down phase. The target heart rate during the aerobic training phase will be 40 to 70% of maximal heart rate (HRmax). After cycling, the participant will engage in a 30-minute of computer-based cognitive training program using BrainHQ (Posit Science Inc., San Francisco, CA, USA). The following are the areas of training: visuospatial processing, attention, memory, language, and logical thinking.; The dual-task training group will cycling concurrently with the computer-based cognitive training. The training principle of cycling and cognitive training is similar to the SEQ group; however, the training intensity will be adjusted according to each participant's ability.; The control participants will receive 60 minutes of health-related rehabilitation programs which involves non-aerobic physical exercise (e.g., muscle stretching, range of motion exercises, relaxation techniques) and unstructured cognitive related rehabilitation programs (e.g., watch health-related videos or read newspapers or magazines and then answer the content-related questions raised by the therapist).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment