Stroke Patients With Cognitive DeclineNCT02550990
Synergistic Effects of Aerobic Exercise and Cognitive Training on Cognition in Stroke Patients With Cognitive Decline
A study testing Cognitive training, Aerobic exercise training and Sequential combination of aerobic exercise and cognitive training in people with Stroke Patients With Cognitive Decline, run by Chang Gung Memorial Hospital at 6 sites in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Stroke Patients With Cognitive Decline
- What is being tested?
- Cognitive training, Aerobic exercise training and Sequential combination of aerobic exercise and cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 6 sitesTaiwan
- Study dates
- Sep 2015to Aug 2018
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic or hemorrhagic stroke occurring at least 6 months prior to enrollment
- Age range from 20 to 90 years
- MMSE score ≥ 19
- MoCA<26
- Self- or informant-reported memory or cognitive complaints or CDR scale ≤ 0.5
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Taiwan6 sites, 6 recruiting
- Recruiting
Chiayi Chang Gung Memorial Hospital
Chiayi City, 613
Shi-Zhe Lin, MS, +886-5-3621000 ext. 2688, apirlline@cgmh.org.tw
- Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
Ku-Chou Chang, MD, +886-7317123 ext. 2285, kcchang@cgmh.org.tw
- Recruiting
Keeling Chang Gung Memorial Hospital
Keelung, 204
Chia-Ling Chen, PhD, +886-3-3281200 ext. 8147, ccl1374@adm.cgmh.com.tw
- Recruiting
Chang Gung Memorial Hospital
Kwei-Shan, Taoyuan, 333
Ching-Yi Wu, ScD, 886-3-2118800 ext. 5761, cywu@mail.cgu.edu.tw
- Recruiting
Taipei Chang Gung Memorial Hospital
Taipei, 105
Chia-Ling Chen, PhD, +886-3-3281200 ext. 8147, ccl1374@adm.cgmh.com.tw
- Recruiting
Taoyuan Chang Gung Memorial Hospital
Taoyuan City, 333
Chia-Ling Chen, PhD, +886-3-3281200 ext. 8147, ccl1374@adm.cgmh.com.tw
About this study
Official title: Synergistic Effects of Aerobic Exercise and Cognitive Training on Cognition, Physiological Markers, Daily Function and Quality of Life in Stroke Patients With Cognitive Decline
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. The investigators hypothesized that: (1) sequential training protocol can improve outcome measures compared to single mode of training; (2) these treatment effects will retain at 6-month follow-up.
- Conditions
- Stroke Patients With Cognitive Decline
- Being tested
- Cognitive training, Aerobic exercise training, Sequential combination of aerobic exercise and cognitive training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive trainingBehavioural
Aerobic exercise trainingBehavioural
Sequential combination of aerobic exercise and cognitive trainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Cognitive training group | Active comparator | One 60-min session of cognitive training. 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. Receives: Behavioral: Cognitive training |
| Aerobic exercise training group | Active comparator | One 60-min session of aerobic exercise training. 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. Receives: Behavioral: Aerobic exercise training |
| Sequential training group | Experimental | One 30-min session of aerobic exercise training + one 30-min session of cognitive training.
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. Receives: Behavioral: Sequential combination of aerobic exercise and cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change scores of Montreal Cognitive Assessment (MoCA)
Measured: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Wechsler Memory Scale - Third Edition (WMS-III)
Measured: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)
Measured: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Useful Field of View (UFOV)
Measured: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Stroop Color-Word test
Measured: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Dual-task test
The dual-task tests will be assessed to determine the ability for an individual to perform 2 tasks simultaneously. The investigators will assess the dual-task performance during walking and performing box and block test. The results of the dual-task tests will provide information regarding to whether the 2 tasks compete for the same class of neural resources or one of the tasks can be carried out automatically.
Measured: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Secondary outcomes (19)
Change scores of serum BDNF level
Measured: Baseline, posttest (an expected average of 3 months)
Change scores of 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)
Change scores of 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)
Change scores of 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)
Change scores of Functional Independence Measure (FIM)
Measured: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Lawton Instrumental Activities of Daily Living Scale (Lawton IADL)
Measured: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Stroke Impact Scale (SIS)
Measured: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Caregiver Burden (CB) scale
Measured: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of EuroQol (EQ)-5D questionnaire
Measured: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Timed up and go test (TUG)
Measured: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Six-minute walk test (6MWT)
Measured: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Mobility level
Measured: Baseline, posttest (an expected average of 3 months)
Change scores of International Physical Activity Questionnaires (IPAQ)
Measured: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Fugl-Meyer Assessment (FMA)
Measured: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Rivermead Mobility Index (RMI)
Measured: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of muscle strength
We will evaluate isometric knee flexors and extensors muscle strength using handheld dynamometer. Also, we will use hand dynamometer to measure grip strength of the affected and less affected hand while the participant is seated, with the elbow at 90-degree flexion. We will record the mean value of 3 attempts.
Measured: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Community Integration Questionnaire (CIQ)
Measured: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Geriatric Depression Scale (GDS)
Measured: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Genotyping of the BDNF val66met polymorphism
Measured: Between baseline and posttest (an expected average of 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stroke Patients With Cognitive DeclineStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02550990
- Sponsor's protocol ID
- 104-4892A3
- Status last verified
- Dec 2016
- First submitted
- 6 Sep 2015
- Last updated
- 20 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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 35349186Yeh TT, Wu CY, Hsieh YW, Chang KC, Lee LC, Hung JW, Lin KC, Teng CH, Liao YH. Synergistic effects of aerobic exercise and cognitive training on cognition, physiological markers, daily function, and quality of life in stroke survivors with cognitive decline: study protocol for a randomized controlled trial. Trials. 2017 Aug 31;18(1):405. doi: 10.1186/s13063-017-2153-7.
PubMed 28859664
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synergistic Effects of Aerobic Exercise and Cognitive Training on Cognition, Physiological Markers, Daily Function and Quality of Life in Stroke Patients With Cognitive Decline
- ClinicalTrials.gov ID
- NCT02550990
- Acronym / sponsor ID
- 104-4892A3
- Conditions
- Stroke Patients With Cognitive Decline
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Aug 2018 (estimated)
- First posted
- 16 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. The investigators hypothesized that: (1) sequential training protocol can improve outcome measures compared to single mode of training; (2) these treatment effects will retain at 6-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive training group | Active comparator | Behavioral: Cognitive trainingOne 60-min session of cognitive training. 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. |
| Aerobic exercise training group | Active comparator | Behavioral: Aerobic exercise trainingOne 60-min session of aerobic exercise training. 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. |
| Sequential training group | Experimental | Behavioral: Sequential combination of aerobic exercise and cognitive trainingOne 30-min session of aerobic exercise training + one 30-min session of cognitive training. 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. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ischemic or hemorrhagic stroke occurring at least 6 months prior to enrollment
- Age range from 20 to 90 years
- MMSE score ≥ 19
- MoCA<26
- Self- or informant-reported memory or cognitive complaints or CDR scale ≤ 0.5
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive training | Behavioural | Cognitive training group |
| Aerobic exercise training | Behavioural | Aerobic exercise training group |
| Sequential combination of aerobic exercise and cognitive training | Behavioural | Sequential training group |
Primary outcome
Change scores of Montreal Cognitive Assessment (MoCA)
Time frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Wechsler Memory Scale - Third Edition (WMS-III)
Time frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)
Time frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Useful Field of View (UFOV)
Time frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Stroop Color-Word test
Time frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Dual-task test
Time frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
The dual-task tests will be assessed to determine the ability for an individual to perform 2 tasks simultaneously. The investigators will assess the dual-task performance during walking and performing box and block test. The results of the dual-task tests will provide information regarding to whether the 2 tasks compete for the same class of neural resources or one of the tasks can be carried out automatically.
19 secondary outcomes
Change scores of serum BDNF level
Time frame: Baseline, posttest (an expected average of 3 months)
Change scores of Antioxidative marker
Time frame: Baseline, posttest (an expected average of 3 months)
Change scores of Glucose indicator
Time frame: Baseline, posttest (an expected average of 3 months)
Change scores of Plasma lipid level
Time frame: Baseline, posttest (an expected average of 3 months)
Change scores of Functional Independence Measure (FIM)
Time frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Lawton Instrumental Activities of Daily Living Scale (Lawton IADL)
Time frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Stroke Impact Scale (SIS)
Time frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Caregiver Burden (CB) scale
Time frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of EuroQol (EQ)-5D questionnaire
Time frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Timed up and go test (TUG)
Time frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Six-minute walk test (6MWT)
Time frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Mobility level
Time frame: Baseline, posttest (an expected average of 3 months)
Change scores of International Physical Activity Questionnaires (IPAQ)
Time frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Fugl-Meyer Assessment (FMA)
Time frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Rivermead Mobility Index (RMI)
Time frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of muscle strength
Time frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Community Integration Questionnaire (CIQ)
Time frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Geriatric Depression Scale (GDS)
Time frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Genotyping of the BDNF val66met polymorphism
Time frame: Between baseline and posttest (an expected average of 3 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2016.
- Derived from this study: PubMed 35349186Gibson 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.
- Derived from this study: PubMed 28859664Yeh TT, Wu CY, Hsieh YW, Chang KC, Lee LC, Hung JW, Lin KC, Teng CH, Liao YH. Synergistic effects of aerobic exercise and cognitive training on cognition, physiological markers, daily function, and quality of life in stroke survivors with cognitive decline: study protocol for a randomized controlled trial. Trials. 2017 Aug 31;18(1):405. doi: 10.1186/s13063-017-2153-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive training, Aerobic exercise training and Sequential combination of aerobic exercise and cognitive training in people with Stroke Patients With Cognitive Decline, run by Chang Gung Memorial Hospital at 6 sites 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 8 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 20 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ching-Yi Wu, ScD (+886-3-2118800 ext. 5761, cywu@mail.cgu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change scores of Montreal Cognitive Assessment (MoCA) (time frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)). The study lists 6 primary outcomes in all. 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 NCT02550990, 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 20 Dec 2016.