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

NCT ID: NCT04012866

Last Updated: 2020-09-09

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-30

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SEQ (sequential training group)

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.

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.

Computerized 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.

DUAL (dual training group)

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.

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.

Computerized 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.

CI (control intervention group)

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.

Group Type ACTIVE_COMPARATOR

Control training

Intervention Type BEHAVIORAL

The Control training will receive an intervention including combinations of non-aerobic physical activities and unstructured mental activities.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Computerized 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

Control training

The Control training will receive an intervention including combinations of non-aerobic physical activities and unstructured mental activities.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ching-yi Wu, ScD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kaohsiung Municipal Siaogang Hospital

Kaohsiung City, , Taiwan

Site Status RECRUITING

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status RECRUITING

Far Eastren Memorial Hospital

New Taipei City, , Taiwan

Site Status RECRUITING

Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ching-yi Wu, ScD

Role: CONTACT

#886-3-2118800 ext. 5761

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

107044-F

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.