Effects and Mechanism of Two Hybrid Exercise-cognitive Trainings in Mild Ischemic Stroke With Cognitive Decline

Chang Gung Medical Foundation

Status: Completed

Conditions: Stroke Patients With Cognitive Decline

Treatments: Behavioral: Control training; Behavioral: Sequential training; Behavioral: Dual training

Study type: Interventional

Funder types: Other

Identifiers

NCT03230253

KMUHIRB-F(II)-20170040

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Stroke occurring at least 6 months prior to enrollment
2. Age range from 20 to 80 years
3. MMSE score < 28 or MoCA<25
4. Able to follow the study instruction
5. Adequate cardiopulmonary function to perform aerobic exercise
6. Able to walk with or without assistive devices

Exclusion criteria

1. Unstable medical history (e.g., recent myocardial infarction) that might limit participation
2. Concomitant with other neurological disorders (e.g., Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis)
3. Current participation in another interventional trial
4. Any contraindication to MRI (metallic implants, claustrophobia, seizure, pacemakers, et al)
5. Pregnant woman

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 3 patient groups

Sequential training group

Experimental group

Description:

Exercise training for 30 minutes followed by 30 minutes of cognitive-based intervention

Treatment:

Behavioral: Sequential training

Dual training group

Experimental group

Description:

Exercise training simultaneously combined cognitive-based intervention for 60 minutes

Treatment:

Behavioral: Dual training

Control training group

Active Comparator group

Description:

non-aerobic exercise (e.g., stretch, range of motion exercise...) and unstructured cognitive rehabilitation programs (e.g., reading newspapers, playing board games...) for 60 minutes

Treatment:

Behavioral: Control training