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Synergistic Effects of Aerobic Exercise and Cognitive Training on Cognition in Stroke Patients With Cognitive Decline

Primary Purpose

Stroke Patients With Cognitive Decline

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Cognitive training
Aerobic exercise training
Sequential combination of aerobic exercise and cognitive training
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke Patients With Cognitive Decline

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 ≥ 19
  4. MoCA<26
  5. Self- or informant-reported memory or cognitive complaints or CDR scale ≤ 0.5
  6. Able to follow the study instruction
  7. Adequate cardiopulmonary function to perform aerobic exercise
  8. 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

Sites / Locations

  • Chang Gung Memorial HospitalRecruiting
  • Chiayi Chang Gung Memorial HospitalRecruiting
  • Kaohsiung Chang Gung Memorial HospitalRecruiting
  • Keeling Chang Gung Memorial HospitalRecruiting
  • Taipei Chang Gung Memorial HospitalRecruiting
  • Taoyuan Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Cognitive training group

Aerobic exercise training group

Sequential training group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change scores of Montreal Cognitive Assessment (MoCA)
Change scores of Wechsler Memory Scale - Third Edition (WMS-III)
Change scores of Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)
Change scores of Useful Field of View (UFOV)
Change scores of Stroop Color-Word test
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.

Secondary Outcome Measures

Change scores of serum BDNF level
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).
Change scores of Glucose indicator
HbA1C level will be tested to investigate the relationships between blood glucose level and aerobic exercise.
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.
Change scores of Functional Independence Measure (FIM)
Change scores of Lawton Instrumental Activities of Daily Living Scale (Lawton IADL)
Change scores of Stroke Impact Scale (SIS)
Change scores of Caregiver Burden (CB) scale
Change scores of EuroQol (EQ)-5D questionnaire
Change scores of Timed up and go test (TUG)
Change scores of Six-minute walk test (6MWT)
Change scores of Mobility level
Change scores of International Physical Activity Questionnaires (IPAQ)
Change scores of Fugl-Meyer Assessment (FMA)
Change scores of Rivermead Mobility Index (RMI)
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.
Change scores of Community Integration Questionnaire (CIQ)
Change scores of Geriatric Depression Scale (GDS)
Genotyping of the BDNF val66met polymorphism

Full Information

First Posted
September 6, 2015
Last Updated
December 19, 2016
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02550990
Brief Title
Synergistic Effects of Aerobic Exercise and Cognitive Training on Cognition in Stroke Patients With Cognitive Decline
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Patients With Cognitive Decline

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive training group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Aerobic exercise training group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sequential training group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive training
Intervention Type
Behavioral
Intervention Name(s)
Aerobic exercise training
Intervention Type
Behavioral
Intervention Name(s)
Sequential combination of aerobic exercise and cognitive training
Primary Outcome Measure Information:
Title
Change scores of Montreal Cognitive Assessment (MoCA)
Time Frame
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Title
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)
Title
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)
Title
Change scores of Useful Field of View (UFOV)
Time Frame
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Title
Change scores of Stroop Color-Word test
Time Frame
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Title
Change scores of Dual-task test
Description
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.
Time Frame
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Secondary Outcome Measure Information:
Title
Change scores of serum BDNF level
Time Frame
Baseline, posttest (an expected average of 3 months)
Title
Change scores of Antioxidative marker
Description
Antioxidative markers will be used to reflect the changes on oxidative stress. In particular, we will be analyzing the total antioxidant capacity (TAC).
Time Frame
Baseline, posttest (an expected average of 3 months)
Title
Change scores of Glucose indicator
Description
HbA1C level will be tested to investigate the relationships between blood glucose level and aerobic exercise.
Time Frame
Baseline, posttest (an expected average of 3 months)
Title
Change scores of Plasma lipid level
Description
The cholesterol ratio (total cholesterol divided by high-density lipid) will be evaluated to reflect the lipid level in the blood.
Time Frame
Baseline, posttest (an expected average of 3 months)
Title
Change scores of Functional Independence Measure (FIM)
Time Frame
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Title
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)
Title
Change scores of Stroke Impact Scale (SIS)
Time Frame
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Title
Change scores of Caregiver Burden (CB) scale
Time Frame
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Title
Change scores of EuroQol (EQ)-5D questionnaire
Time Frame
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Title
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)
Title
Change scores of Six-minute walk test (6MWT)
Time Frame
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Title
Change scores of Mobility level
Time Frame
Baseline, posttest (an expected average of 3 months)
Title
Change scores of International Physical Activity Questionnaires (IPAQ)
Time Frame
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Title
Change scores of Fugl-Meyer Assessment (FMA)
Time Frame
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Title
Change scores of Rivermead Mobility Index (RMI)
Time Frame
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Title
Change scores of muscle strength
Description
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.
Time Frame
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Title
Change scores of Community Integration Questionnaire (CIQ)
Time Frame
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Title
Change scores of Geriatric Depression Scale (GDS)
Time Frame
Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Title
Genotyping of the BDNF val66met polymorphism
Time Frame
Between baseline and posttest (an expected average of 3 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ching-Yi Wu, ScD
Phone
+886-3-2118800
Ext
5761
Email
cywu@mail.cgu.edu.tw
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Kwei-Shan
State/Province
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ching-Yi Wu, ScD
Phone
886-3-2118800
Ext
5761
Email
cywu@mail.cgu.edu.tw
Facility Name
Chiayi Chang Gung Memorial Hospital
City
Chiayi City
ZIP/Postal Code
613
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shi-Zhe Lin, MS
Phone
+886-5-3621000
Ext
2688
Email
apirlline@cgmh.org.tw
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung City
ZIP/Postal Code
83301
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ku-Chou Chang, MD
Phone
+886-7317123
Ext
2285
Email
kcchang@cgmh.org.tw
Facility Name
Keeling Chang Gung Memorial Hospital
City
Keelung City
ZIP/Postal Code
204
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chia-Ling Chen, PhD
Phone
+886-3-3281200
Ext
8147
Email
ccl1374@adm.cgmh.com.tw
Facility Name
Taipei Chang Gung Memorial Hospital
City
Taipei City
ZIP/Postal Code
105
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chia-Ling Chen, PhD
Phone
+886-3-3281200
Ext
8147
Email
ccl1374@adm.cgmh.com.tw
Facility Name
Taoyuan Chang Gung Memorial Hospital
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chia-Ling Chen, PhD
Phone
+886-3-3281200
Ext
8147
Email
ccl1374@adm.cgmh.com.tw

12. IPD Sharing Statement

Citations:
PubMed Identifier
35349186
Citation
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.
Results Reference
derived
PubMed Identifier
28859664
Citation
Yeh 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.
Results Reference
derived

Learn more about this trial

Synergistic Effects of Aerobic Exercise and Cognitive Training on Cognition in Stroke Patients With Cognitive Decline

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