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

Not Applicable

• Conditions: Stroke Patients With Cognitive Decline
• Interventions: Behavioral: Cognitive training; Behavioral: Aerobic exercise training; Behavioral: Sequential combination of aerobic exercise and cognitive training

• Registration Number: NCT02550990
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-06
• Study First Submitted QC: 2015-09-14
• Study First Posted: 2015-09-16
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-19
• Last Update Posted: 2016-12-20
• Primary Completion: 2018-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive training group	Cognitive training	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.
Aerobic exercise training group	Aerobic exercise training	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.
Sequential training group	Sequential combination of aerobic exercise and cognitive training	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.

Primary Outcome Measures

Name	Time	Method
Change scores of Stroop Color-Word test	Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
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 Adult Intelligence Scale - Third Edition (WAIS-III)	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 Useful Field of View (UFOV)	Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Change scores of Dual-task test	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.

Secondary Outcome Measures

Name	Time	Method
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 EuroQol (EQ)-5D questionnaire	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 Plasma lipid level	Baseline, posttest (an expected average of 3 months)	The cholesterol ratio (total cholesterol divided by high-density lipid) will be evaluated to reflect the lipid level in the blood.
Change scores of serum BDNF level	Baseline, posttest (an expected average of 3 months)
Change scores of Antioxidative marker	Baseline, posttest (an expected average of 3 months)	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 Functional Independence Measure (FIM)	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 Glucose indicator	Baseline, posttest (an expected average of 3 months)	HbA1C level will be tested to investigate the relationships between blood glucose level and aerobic exercise.
Change scores of Fugl-Meyer Assessment (FMA)	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)
Genotyping of the BDNF val66met polymorphism	Between baseline and posttest (an expected average of 3 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 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 muscle strength	Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)	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 Geriatric Depression Scale (GDS)	Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

Trial Locations

Locations (6)

Chiayi Chang Gung Memorial Hospital; 🇨🇳 Chiayi City, Taiwan

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung City, Taiwan

Keeling Chang Gung Memorial Hospital; 🇨🇳 Keelung City, Taiwan

Chang Gung Memorial Hospital; 🇨🇳 Kwei-Shan, Taoyuan, Taiwan

Taipei Chang Gung Memorial Hospital; 🇨🇳 Taipei City, Taiwan

Taoyuan Chang Gung Memorial Hospital; 🇨🇳 Taoyuan City, Taiwan