Clinical trial NCT03045991: Effects and Mechanism of the Sequential Combination of Exercise and Cognitive Training in Stroke Patients
Official title: The Effects and Mechanism of the Sequential Combination of Exercise and Cognitive Training on Cognitive Function in Stroke Patients With Cognitive Decline: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke Patients With Cognitive Decline
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 2
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Cognitive decline after stroke is a common sequela and is highly associated with functional disability. Empirical evidence shows that exercise combined cognitive training may induce neuroplastic changes that modulate cognitive function. However, evidence about the effects of combined exercise-cognitive trainings on physiological biomarkers, cognitive and physical functions in stroke patients with cognitive decline is still less. The present study aim to investigate the effects of sequential combination of exercise-cognitive trainings on cognitive, physical, and daily function. In addition, the physiological mechanism of the combination training on cognitive function by several biomarkers including the brain-derived neurotrophic factor (BDNF), antioxidative marker, HbA1c, and plasma lipid level will be investigated. This study is a single-blind randomized controlled trial. Participants will be randomly assigned to SEQ group in which sequentially perform physical exercise and cognitive training or to CI group of control intervention.

Eligibility criteria: Inclusion Criteria:

1. Ischemic or hemorrhagic stroke occurring at least 6 months prior to enrollment
2. MMSE score ≥ 19,MoCA\<26,able to follow the study instruction
3. Self- or informant-reported memory or cognitive complaints or CDR scale ≤ 0.5
4. Adequate cardiopulmonary function to perform aerobic exercise
5. 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

Primary outcomes:
measure: Change scores of Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Change scores of Wechsler Memory Scale - Third Edition (WMS-III)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Change scores of Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Change scores of Useful Field of View (UFOV)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Change scores of Stroop Color-Word test
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Change scores of Dual-task test
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Secondary outcomes:
measure: Change scores of serum BDNF level
timeFrame: Baseline, posttest (an expected average of 3 months)
measure: Change scores of Antioxidative marker
timeFrame: Baseline, posttest (an expected average of 3 months)
measure: Change scores of Glucose indicator
timeFrame: Baseline, posttest (an expected average of 3 months)
measure: Change scores of Plasma lipid level
timeFrame: Baseline, posttest (an expected average of 3 months)
measure: Change scores of Functional Independence Measure (FIM)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Change scores of Lawton Instrumental Activities of Daily Living Scale (Lawton IADL)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Change scores of Stroke Impact Scale (SIS)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Change scores of Caregiver Burden (CB) scale
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Change scores of EuroQol (EQ)-5D questionnaire
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Change scores of Timed up and go test (TUG)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Change scores of Six-minute walk test (6MWT)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Change scores of Mobility level
timeFrame: Baseline, posttest (an expected average of 3 months)
measure: Change scores of International Physical Activity Questionnaires (IPAQ)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Change scores of Fugl-Meyer Assessment (FMA)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Change scores of Rivermead Mobility Index (RMI)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Change scores of muscle strength
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Change scores of Community Integration Questionnaire (CIQ)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Change scores of Geriatric Depression Scale (GDS)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Genotyping of the BDNF val66met polymorphism
timeFrame: Once during the intervention(an expected average of 3 months)
measure: Change scores of Actigraphy
timeFrame: Baseline, posttest (an expected average of 3 months)
measure: Change scores of Mini-Mental State Exam (MMSE)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Change scores of Medical Research Council scale (MRC)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Change scores of National Institutes of Health Stroke Scale
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Other outcomes:
Locations:
city: Chiayi City
country: Taiwan
facility: Chiayi Chang Gung Memorial Hospital
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Keelung
country: Taiwan
facility: Keeling Chang Gung Memorial Hospital
city: Taipei City
country: Taiwan
facility: Taipei Chang Gung Memorial Hospital
city: Taoyuan City
country: Taiwan
facility: Taoyuan Chang Gung Memorial Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung University
name: Ching-Yi Wu, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yeh TT, Chang KC, Wu CY. The Active Ingredient of Cognitive Restoration: A Multicenter Randomized Controlled Trial of Sequential Combination of Aerobic Exercise and Computer-Based Cognitive Training in Stroke Survivors With Cognitive Decline. Arch Phys Med Rehabil. 2019 May;100(5):821-827. doi: 10.1016/j.apmr.2018.12.020. Epub 2019 Jan 9.