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

October 22, 2020 updated by: Chang Gung Memorial Hospital

Effects and Mechanism of Two Hybrid Exercise-cognitive Trainings in Mild Ischemic Stroke With Cognitive Decline: fMRI for Brain Plasticity, and Biomarker and Behavioral Analysis

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 812
        • Kaohsiung Municipal Siaogang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sequential training group
Exercise training for 30 minutes followed by 30 minutes of cognitive-based intervention
Behavioral: Sequential training
The participant will cycle on a stationary bike for 30 minutes, which includes a 3-min warm-up phase followed by the aerobic training components (25 minutes), then a 2-min cool-down phase. The target heart rate during the aerobic training phase will be 40 to 70% of maximal heart rate (HRmax). After cycling, the participant will engage in a 30-minute of computer-based cognitive training program using BrainHQ (Posit Science Inc., San Francisco, CA, USA). The following are the areas of training: visuospatial processing, attention, memory, language, and logical thinking.
Experimental: Dual training group
Exercise training simultaneously combined cognitive-based intervention for 60 minutes
Behavioral: Dual training
The dual-task training group will cycling concurrently with the computer-based cognitive training. The training principle of cycling and cognitive training is similar to the SEQ group; however, the training intensity will be adjusted according to each participant's ability.
Active Comparator: Control training group
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
Behavioral: Control training
The control participants will receive 60 minutes of health-related rehabilitation programs which involves non-aerobic physical exercise (e.g., muscle stretching, range of motion exercises, relaxation techniques) and unstructured cognitive related rehabilitation programs (e.g., watch health-related videos or read newspapers or magazines and then answer the content-related questions raised by the therapist).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
fMRI (change is being assessed)
Time Frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months).
Resting-state functional connectivity and neural activation in the frontal, parietal and occipital lobes
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serum BDNF level
Time Frame: Baseline, posttest (an expected average of 3 months)
Up-regulation of neurotrophic and vascular growth factors
Baseline, posttest (an expected average of 3 months)
Antioxidative marker
Time Frame: Baseline, posttest (an expected average of 3 months)]
Antioxidative markers will be used to reflect the changes on oxidative stress. In particular, we will be analyzing the total antioxidant capacity (TAC).
Baseline, posttest (an expected average of 3 months)]
Glucose indicator
Time Frame: Baseline, posttest (an expected average of 3 months)
HbA1C level will be tested to investigate the relationships between blood glucose level and aerobic exercise
Baseline, posttest (an expected average of 3 months)
Plasma lipid level
Time Frame: Baseline, posttest (an expected average of 3 months)
The cholesterol ratio (total cholesterol divided by high-density lipid) will be evaluated to reflect the lipid level in the blood
Baseline, posttest (an expected average of 3 months)
Montreal Cognitive Assessment (MoCA)
Time Frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
The MoCA will be used to assess general cognitive functions. It examines several cognitive domains with a total score of 30
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Wechsler Memory Scale - Third Edition (WMS-III)
Time Frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
The WMS-III is a standardized and reliable neuropsychological examination tool designed to evaluate visuospatial and memory functions
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)
Time Frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
The WAIS-III is developed to measure an individual's intelligence level. It includes tests that evaluate cognitive functions in verbal comprehension, working memory, perceptual organization, and processing speed
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Useful Field of View (UFOV)
Time Frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
The UFOV assessment is a computer-based visual test containing three subtests: visuomotor processing speed, divided attention, and selective attention.
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Stroop Color-Word test
Time Frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
The Stroop Color-Word assesses the abilities of selective attention, inhibition and executive function. The participants will be tested under congruent and incongruent conditions.
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Dual-task test
Time Frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
The dual-task test evaluates the ability to shift attention between one task and another. Participants will perform the box and block test (BBT) while doing secondary cognitive tasks while sitting. Participants will perform BBT by affected and less affected hand.
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Time up and go test (TUG)
Time Frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
The TUG assesses the dynamic balance ability and mobility. The participants will be required to stand up from a chair, walk 3 meters, turn around, walk back to the chair, and sit down.
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Six-minute walk test (6MWT)
Time Frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
The 6MWT measures the maximum distance walked over 6 minutes, which assess the endurance and mobility level of the participants. The participants could rest as needed during the course of the test.
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
International Physical Activity Questionnaires (IPAQ)
Time Frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
The IPAQ is an international measure of health-related physical activity.
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Fugl-Meyer Assessment (FMA)
Time Frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
The 33-item upper limb subscale of the FMA will be used to assess motor impairments.
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Rivermead Mobility Index (RMI)
Time Frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
The RMI evaluates the participant's bed mobility, postural transfers and walking ability. It contains a 15-item scale which includes 14 questions and one direct observation, with a total of score of 15.
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Muscle strength
Time Frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Accelerometers will be used to provide an objective measure of the amount of arm movements in real-life situations. The participants will be asked to wear an Actigraphy activity monitor.
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Mobility level
Time Frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Accelerometers will be used to provide an objective measure of the amount of arm movements in real-life situations. The participants will be asked to wear an Actigraphy activity monitor.
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Functional Independence Measure (FIM)
Time Frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
The FIM assesses the dependence level of individuals with stroke to perform 18 activities (13 motor and five cognitive tasks) in daily living. The score ranges from 18 to 126 and higher scores demonstrate greater independent participation in daily activities.
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Lawton Instrumental Activities of Daily Living Scale (Lawton LADL)
Time Frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
The Lawton IADL scale assesses independent living skills, such as shopping or managing finances.
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Stroke Impact Scale (SIS)
Time Frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
The SIS 3.0 will be used to evaluate health-related quality of life for patients with stroke. The SIS assesses eight domains (strength, hand function, ADL/IADL, mobility, communication, emotion, memory and thinking, and participation/role function) with 59 test items.
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Caregiver Burden Scale (CB scale)
Time Frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
B scale evaluates the burden of the primary caregiver of the participants. Lessening the burden of caregivers after the intervention may significantly improve the quality of life for patients with stroke and their family.
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
EuroQol-5D questionnaire (EQ-5D)
Time Frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
The quality of life will be assessed by the EQ-5D questionnaire which comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chang Gung Memorial Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ching-yi Wu, ScD, Chang Gung University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 19, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 3, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 26, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 26, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KMUHIRB-F(II)-20170040

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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