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

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.

Study Overview

• Status: Unknown
• Conditions: Stroke Patients With Cognitive Decline
• Intervention / Treatment: Behavioral: Cognitive training; Behavioral: Aerobic exercise training; Behavioral: Sequential combination of aerobic exercise and cognitive training

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Chiayi City, Taiwan, 613
    • Recruiting
    • Chiayi Chang Gung Memorial Hospital
    • Contact: Shi-Zhe Lin, MS; Phone Number: 2688 +886-5-3621000; Email: apirlline@cgmh.org.tw
  • Kaohsiung City, Taiwan, 83301
    • Recruiting
    • Kaohsiung Chang Gung Memorial Hospital
    • Contact: Ku-Chou Chang, MD; Phone Number: 2285 +886-7317123; Email: kcchang@cgmh.org.tw
  • Keelung City, Taiwan, 204
    • Recruiting
    • Keeling Chang Gung Memorial Hospital
    • Contact: Chia-Ling Chen, PhD; Phone Number: 8147 +886-3-3281200; Email: ccl1374@adm.cgmh.com.tw
  • Taipei City, Taiwan, 105
    • Recruiting
    • Taipei Chang Gung Memorial hospital
    • Contact: Chia-Ling Chen, PhD; Phone Number: 8147 +886-3-3281200; Email: ccl1374@adm.cgmh.com.tw
  • Taoyuan City, Taiwan, 333
    • Recruiting
    • Taoyuan Chang Gung Memorial Hospital
    • Contact: Chia-Ling Chen, PhD; Phone Number: 8147 +886-3-3281200; Email: ccl1374@adm.cgmh.com.tw
  • Taoyuan
    • Kwei-Shan, Taoyuan, Taiwan, 333
      • Recruiting
      • Chang Gung memorial hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cognitive training group; 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.	Behavioral: Cognitive training
Active Comparator: Aerobic exercise training group; 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.	Behavioral: Aerobic exercise training
Experimental: Sequential training group; 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.	Behavioral: Sequential combination of aerobic exercise and cognitive training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change scores of Montreal Cognitive Assessment (MoCA)		Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Wechsler Memory Scale - Third Edition (WMS-III)		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)		Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Useful Field of View (UFOV)		Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Stroop Color-Word test		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.	Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	Baseline, posttest (an expected average of 3 months)
Change scores of serum BDNF level		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.	Baseline, posttest (an expected average of 3 months)
Change scores of Functional Independence Measure (FIM)		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)		Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Stroke Impact Scale (SIS)		Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Caregiver Burden (CB) scale		Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of EuroQol (EQ)-5D questionnaire		Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Timed up and go test (TUG)		Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Six-minute walk test (6MWT)		Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Mobility level		Baseline, posttest (an expected average of 3 months)
Change scores of International Physical Activity Questionnaires (IPAQ)		Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Fugl-Meyer Assessment (FMA)		Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Rivermead Mobility Index (RMI)		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.	Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Community Integration Questionnaire (CIQ)		Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Geriatric Depression Scale (GDS)		Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Genotyping of the BDNF val66met polymorphism		Between baseline and posttest (an expected average of 3 months)

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): August 1, 2018

Study Registration Dates

• First Submitted: September 6, 2015
• First Submitted That Met QC Criteria: September 14, 2015
• First Posted (Estimate): September 16, 2015

Study Record Updates

• Last Update Posted (Estimate): December 20, 2016
• Last Update Submitted That Met QC Criteria: December 19, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Cognition Disorders; Stroke; Cognitive Dysfunction
• Other Study ID Numbers: 104-4892A3