AzTrials
AzTrials

Stroke Patients With Cognitive DeclineNCT03230253

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

A study testing Sequential training and Dual training in people with Stroke Patients With Cognitive Decline, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Stroke Patients With Cognitive Decline
What is being tested?
Sequential training and Dual training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteTaiwan
Study dates
19 Apr 2018to 31 Jul 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Stroke occurring at least 6 months prior to enrollment
  • Age range from 20 to 80 years
  • MMSE score < 28 or MoCA<25
  • Able to follow the study instruction
  • Adequate cardiopulmonary function to perform aerobic exercise
  • Able to walk with or without assistive devices

Who cannot join

  • Unstable medical history (e.g., recent myocardial infarction) that might limit participation
  • Concomitant with other neurological disorders (e.g., Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis)
  • Current participation in another interventional trial
  • Any contraindication to MRI (metallic implants, claustrophobia, seizure, pacemakers, et al)
  • Pregnant woman

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Kaohsiung Municipal Siaogang Hospital

    Kaohsiung City, 812

Other trials in Taiwan

About this study

Official title: 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.

Read the 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.

Being tested
Sequential training, Dual training, Control training

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sequential trainingBehavioural

    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.

  • Dual trainingBehavioural

    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.

  • Control trainingBehavioural

    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).

Study groups in NCT03230253
Study groupRoleWhat they receive
Sequential training groupExperimentalExercise training for 30 minutes followed by 30 minutes of cognitive-based intervention
Receives: Behavioral: Sequential training
Dual training groupExperimentalExercise training simultaneously combined cognitive-based intervention for 60 minutes
Receives: Behavioral: Dual training
Control training groupActive comparatornon-aerobic exercise (e.g., stretch, range of motion exercise...) and unstructured cognitive rehabilitation programs (e.g., reading newspapers, playing board games...) for 60 minutes
Receives: Behavioral: Control training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. fMRI (change is being assessed)

    Resting-state functional connectivity and neural activation in the frontal, parietal and occipital lobes

    Measured: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months).

Secondary outcomes (22)

  1. Serum BDNF level

    Up-regulation of neurotrophic and vascular growth factors

    Measured: Baseline, posttest (an expected average of 3 months)

  2. Antioxidative marker

    Antioxidative markers will be used to reflect the changes on oxidative stress. In particular, we will be analyzing the total antioxidant capacity (TAC).

    Measured: Baseline, posttest (an expected average of 3 months)]

  3. Glucose indicator

    HbA1C level will be tested to investigate the relationships between blood glucose level and aerobic exercise

    Measured: Baseline, posttest (an expected average of 3 months)

  4. Plasma lipid level

    The cholesterol ratio (total cholesterol divided by high-density lipid) will be evaluated to reflect the lipid level in the blood

    Measured: Baseline, posttest (an expected average of 3 months)

  5. Montreal Cognitive Assessment (MoCA)

    The MoCA will be used to assess general cognitive functions. It examines several cognitive domains with a total score of 30

    Measured: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

  6. Wechsler Memory Scale - Third Edition (WMS-III)

    The WMS-III is a standardized and reliable neuropsychological examination tool designed to evaluate visuospatial and memory functions

    Measured: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

  7. Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)

    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

    Measured: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

  8. Useful Field of View (UFOV)

    The UFOV assessment is a computer-based visual test containing three subtests: visuomotor processing speed, divided attention, and selective attention.

    Measured: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

  9. Stroop Color-Word test

    The Stroop Color-Word assesses the abilities of selective attention, inhibition and executive function. The participants will be tested under congruent and incongruent conditions.

    Measured: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

  10. Dual-task test

    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.

    Measured: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

  11. Time up and go test (TUG)

    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.

    Measured: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

  12. Six-minute walk test (6MWT)

    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.

    Measured: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

  13. International Physical Activity Questionnaires (IPAQ)

    The IPAQ is an international measure of health-related physical activity.

    Measured: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

  14. Fugl-Meyer Assessment (FMA)

    The 33-item upper limb subscale of the FMA will be used to assess motor impairments.

    Measured: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

  15. Rivermead Mobility Index (RMI)

    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.

    Measured: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

  16. Muscle strength

    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.

    Measured: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

  17. Mobility level

    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.

    Measured: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

  18. Functional Independence Measure (FIM)

    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.

    Measured: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

  19. Lawton Instrumental Activities of Daily Living Scale (Lawton LADL)

    The Lawton IADL scale assesses independent living skills, such as shopping or managing finances.

    Measured: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

  20. Stroke Impact Scale (SIS)

    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.

    Measured: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

  21. Caregiver Burden Scale (CB scale)

    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.

    Measured: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

  22. EuroQol-5D questionnaire (EQ-5D)

    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.

    Measured: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2017
  2. Study start19 Apr 2018
  3. Primary completion3 Jul 2020
  4. Study completion31 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03230253
Sponsor's protocol ID
KMUHIRB-F(II)-20170040
Status last verified
Sep 2020
First submitted
18 Jul 2017
Last updated
26 Oct 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Yeh TT, Chang KC, Wang JJ, Lin WC, Wu CY. Neuroplastic Changes Associated With Hybrid Exercise-Cognitive Training in Stroke Survivors With Mild Cognitive Decline: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2023 Sep;37(9):662-673. doi: 10.1177/15459683231200220.

    PubMed 37750660

  • Gibson E, Koh CL, Eames S, Bennett S, Scott AM, Hoffmann TC. Occupational therapy for cognitive impairment in stroke patients. Cochrane Database Syst Rev. 2022 Mar 29;3(3):CD006430. doi: 10.1002/14651858.CD006430.pub3.

    PubMed 35349186

Questions about this trial

What is this clinical trial studying?

A study testing Sequential training and Dual training in people with Stroke Patients With Cognitive Decline, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

fMRI (change is being assessed) (time frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03230253, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in