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

Chang Gung Medical Foundation logo

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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