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

NCT ID: NCT03045991

Last Updated: 2020-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2019-11-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stroke Patients With Cognitive Decline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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sequential training group (SEQ)

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.

Group Type EXPERIMENTAL

aerobic exercise training

Intervention Type BEHAVIORAL

The aerobic exercise program using progressive resistive stationary bicycle training which will contain warm-up, resistive physical exercise, and cool-down. The training resistance will increase with improvement of participants' performance.

cognitive training

Intervention Type BEHAVIORAL

The computerized cognitive training program will be implemented with the brainHQ to target abilities of visuospatial processing, attention, memory, and executive function. The level of the training program will become more difficult with progress in participants' targeted cognitive abilities.

control intervention group (CI)

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.

Group Type ACTIVE_COMPARATOR

control training

Intervention Type BEHAVIORAL

The control training program will receive 30 minutes non-aerobic exercise training, including stretching muscle skills, joint mobility exercises; in addition to one 30-minute session of unstructured mental activities, such as reading books or reading educational films.

Interventions

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aerobic exercise training

The aerobic exercise program using progressive resistive stationary bicycle training which will contain warm-up, resistive physical exercise, and cool-down. The training resistance will increase with improvement of participants' performance.

Intervention Type BEHAVIORAL

control training

The control training program will receive 30 minutes non-aerobic exercise training, including stretching muscle skills, joint mobility exercises; in addition to one 30-minute session of unstructured mental activities, such as reading books or reading educational films.

Intervention Type BEHAVIORAL

cognitive training

The computerized cognitive training program will be implemented with the brainHQ to target abilities of visuospatial processing, attention, memory, and executive function. The level of the training program will become more difficult with progress in participants' targeted cognitive abilities.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ching-Yi Wu, ScD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung University

Locations

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Chiayi Chang Gung Memorial Hospital

Chiayi City, , Taiwan

Site Status

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

Keeling Chang Gung Memorial Hospital

Keelung, , Taiwan

Site Status

Taipei Chang Gung Memorial Hospital

Taipei, , Taiwan

Site Status

Taoyuan Chang Gung Memorial Hospital

Taoyuan, , Taiwan

Site Status

Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status

Countries

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Taiwan

References

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Yeh TT, Chang KC, Wu CY. The Active Ingredient of Cognitive Restoration: A Multicenter Randomized Controlled Trial of Sequential Combination of Aerobic Exercise and Computer-Based Cognitive Training in Stroke Survivors With Cognitive Decline. Arch Phys Med Rehabil. 2019 May;100(5):821-827. doi: 10.1016/j.apmr.2018.12.020. Epub 2019 Jan 9.

Reference Type DERIVED
PMID: 30639273 (View on PubMed)

Other Identifiers

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201600871A3

Identifier Type: -

Identifier Source: org_study_id

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