Effects and Mechanism of the Sequential Combination of Exercise and Cognitive Training in Stroke Patients

Chang Gung Medical Foundation

Status: Completed

Conditions: Stroke Patients With Cognitive Decline

Treatments: Behavioral: cognitive training; Behavioral: control training; Behavioral: aerobic exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT03045991

201600871A3

Details and patient eligibility

About

The purpose of this study is to determine the treatment effects of sequential combination of aerobic exercise and cognitive training on cognitive function, physiological markers, daily function, physical function, social participation and quality of life in stroke patients with cognitive decline.

Full description

Cognitive decline after stroke is a common sequela and is highly associated with functional disability. Empirical evidence shows that exercise combined cognitive training may induce neuroplastic changes that modulate cognitive function. However, evidence about the effects of combined exercise-cognitive trainings on physiological biomarkers, cognitive and physical functions in stroke patients with cognitive decline is still less. The present study aim to investigate the effects of sequential combination of exercise-cognitive trainings on cognitive, physical, and daily function. In addition, the physiological mechanism of the combination training on cognitive function by several biomarkers including the brain-derived neurotrophic factor (BDNF), antioxidative marker, HbA1c, and plasma lipid level will be investigated. This study is a single-blind randomized controlled trial. Participants will be randomly assigned to SEQ group in which sequentially perform physical exercise and cognitive training or to CI group of control intervention.

Enrollment: 2 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Ischemic or hemorrhagic stroke occurring at least 6 months prior to enrollment
2. MMSE score ≥ 19,MoCA<26,able to follow the study instruction
3. Self- or informant-reported memory or cognitive complaints or CDR scale ≤ 0.5
4. Adequate cardiopulmonary function to perform aerobic exercise
5. 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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2 participants in 2 patient groups

sequential training group (SEQ)

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, three days per week for 12 weeks, a total of 36 training sessions. Before and after the treatment, a total of 2 evaluations were conducted, including clinical assessments and blood test (each 18c.c.). A saliva sample (2 mL) will only be collected once from each subject. A follow-up assessment of clinical outcomes will be conducted at six month after the end of the course of treatment.

Treatment:

Behavioral: aerobic exercise training

Behavioral: cognitive training

control intervention group (CI)

Active Comparator group

Description:

The control intervention group (CI) will receive a control training session for 60 minutes per day, three days per week for 12 weeks, a total of 36 training sessions. Before and after the treatment, a total of 2 evaluations were conducted, including clinical assessments and blood test (each 18c.c.). A saliva sample (2 mL) will only be collected once from each subject. A follow-up assessment of clinical outcomes will be conducted at six month after the end of the course of treatment.

Treatment:

Behavioral: control training