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

Chang Gung Memorial Hospital75 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Stroke Patients With Cognitive Decline

Interventions

Cognitive trainingBEHAVIORAL

Aerobic exercise trainingBEHAVIORAL

Sequential combination of aerobic exercise and cognitive trainingBEHAVIORAL

Eligibility

Sex: ALLMin age: 20 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (6)

Chang Gung Memorial Hospital

Kwei-Shan, Taoyuan, Taiwan

RECRUITING

Chiayi Chang Gung Memorial Hospital

Chiayi City, Taiwan

RECRUITING

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Outcomes

Primary Outcomes

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

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 Outcomes

Change scores of serum BDNF level

Time frame: 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).

Central Contacts

Ching-Yi Wu, ScD

CONTACT

+886-3-2118800 cywu@mail.cgu.edu.tw

Data from ClinicalTrials.gov

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Keeling Chang Gung Memorial Hospital

Keelung, Taiwan

RECRUITING

Taipei Chang Gung Memorial Hospital

Taipei, Taiwan

RECRUITING

Taoyuan Chang Gung Memorial Hospital

Taoyuan, Taiwan

RECRUITING

Time frame: 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.

Time frame: 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.

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

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)

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)