Effects of Combined Cognitive Training With Aerobic Exercise in Stroke Patients With MCI

Chang Gung Medical Foundation

Status: Unknown

Conditions: Stroke

Treatments: Behavioral: Computerized cognitive training; Behavioral: Control training; Behavioral: Aerobic exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT04012866

107044-F

Details and patient eligibility

About

Cognitive impairments have severe impact on functional recovery and quality of life after stroke. Current evidence indicated that combining exercise and cognitive training may provide additional benefits on cognition in stroke. This study aims to investigate the effects and mechanisms of two combined methods of computer-based cognitive training with physical exercise in stroke patients with cognitive impairments.

Full description

Cognitive impairment is not uncommon after stroke. Stroke patients with cognitive decline may experience difficulties in learning motor tasks, functional disability, and poor quality of life. Interventions for cognitive impairment remain under development and pharmaceutical intervention is not yet optimal at present. Targeted cognitive treatments or aerobic exercise training provided potential benefits to enhance cognitive function for stroke patients with cognitive decline. Recent studies demonstrate that combining exercise and cognitive training may provide additional benefits on cognition than single type of training. However, physical exercise training and cognitive-based intervention can be combined either sequentially or simultaneously. It remains unclear whether the two combination methods induce similar or differential effects in brain plasticity, physiological modulation, and behavioral outcomes for individuals with stroke. It is important to examine the potential effects, comparative effects and the neural mechanism of two combined interventions that can possibly maximize benefits for stroke survivors with cognitive impairments.

The purposes of the present study are to: (1) examine and compare the effects of two combined interventions on brain plasticity, physiological biomarkers and behavioral outcomes, including cognitive, physical, and daily functions, and quality of life, from pre- to post-training; (2) understand the neural mechanisms of cognitive recovery following two combined interventions using the electroencephalography (EEG); (3) examine the long-term benefits following the two combined interventions; (4) to identify the correlations between brain activity, biomarkers and behavioral measures.

Enrollment: 75 estimated patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Ischemic or hemorrhagic stroke occurring at least 6 months prior to enrollment
2. Age range from 20 to 90 years
3. MMSE score < 28, or MoCA score < 25
4. Self- or informant-reported memory or cognitive complaints or Clinical dementia rating (CDR) scale ≤ 0.5
5. Able to follow the study instruction
6. Adequate cardiopulmonary function to perform aerobic exercise
7. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 3 patient groups

SEQ (sequential training group)

Experimental group

Description:

The sequential training group (SEQ) will first receive 30-minutes aerobic exercise training followed by 30-minutes computerized cognitive training. All participants will receive a training session for 60 minutes per day, two or three days per week for 12-18 weeks, a total of 36 training sessions.

Treatment:

Behavioral: Computerized cognitive training

Behavioral: Aerobic exercise training

DUAL (dual training group)

Experimental group

Description:

The dual training group (DUAL) will receive aerobic exercise training and computerized cognitive training simultaneously. All participants will receive a training session for 60 minutes per day, two or three days per week for 12-18 weeks, a total of 36 training sessions.

Treatment:

Behavioral: Computerized cognitive training

Behavioral: Aerobic exercise training

CI (control intervention group)

Active Comparator group

Description:

The control intervention group (CI) will receive a control training session for 60 minutes per day, two or three days per week for 12-18 weeks, a total of 36 training sessions.

Treatment:

Behavioral: Control training