Clinical trial NCT04012866: Effects of Combined Cognitive Training With Aerobic Exercise in Stroke Patients With MCI
Official title: Effects of the Combined Cognitive Training and Aerobic Exercise on Cognition, Physiological Markers, Daily Function, and Quality of Life in Stroke Patients With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Cognitive Rehabilitation
Aerobic Exercise
Computerized Cognitive Training
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 75
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cognitive impairments have severe impact on functional recovery and quality of life after stroke. Current evidence indicated that combining exercise and cognitive training may provide additional benefits on cognition in stroke. This study aims to investigate the effects and mechanisms of two combined methods of computer-based cognitive training with physical exercise in stroke patients with cognitive impairments.

Detailed description: Cognitive impairment is not uncommon after stroke. Stroke patients with cognitive decline may experience difficulties in learning motor tasks, functional disability, and poor quality of life. Interventions for cognitive impairment remain under development and pharmaceutical intervention is not yet optimal at present. Targeted cognitive treatments or aerobic exercise training provided potential benefits to enhance cognitive function for stroke patients with cognitive decline. Recent studies demonstrate that combining exercise and cognitive training may provide additional benefits on cognition than single type of training. However, physical exercise training and cognitive-based intervention can be combined either sequentially or simultaneously. It remains unclear whether the two combination methods induce similar or differential effects in brain plasticity, physiological modulation, and behavioral outcomes for individuals with stroke. It is important to examine the potential effects, comparative effects and the neural mechanism of two combined interventions that can possibly maximize benefits for stroke survivors with cognitive impairments.

The purposes of the present study are to: (1) examine and compare the effects of two combined interventions on brain plasticity, physiological biomarkers and behavioral outcomes, including cognitive, physical, and daily functions, and quality of life, from pre- to post-training; (2) understand the neural mechanisms of cognitive recovery following two combined interventions using the electroencephalography (EEG); (3) examine the long-term benefits following the two combined interventions; (4) to identify the correlations between brain activity, biomarkers and behavioral measures.

Eligibility criteria: 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 \< 28, or MoCA score \< 25
4. Self- or informant-reported memory or cognitive complaints or Clinical dementia rating (CDR) scale ≤ 0.5
5. Able to follow the study instruction
6. Adequate cardiopulmonary function to perform aerobic exercise
7. 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 Mini-Mental State Exam (MMSE)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Change scores of the 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)
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-Myer 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 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 EuroQol-5D Questionnaire (EQ-5D)
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: Task-based Electroencephalogram (EEG)
timeFrame: Baseline, posttest (an expected average of 3 months)
measure: BDNF val66met genotype
timeFrame: Baseline
measure: Serum BDNF level
timeFrame: Baseline, posttest (an expected average of 3 months)
measure: Total antioxidant capacity (TAC)
timeFrame: Baseline, posttest (an expected average of 3 months)
measure: Glucose indicator
timeFrame: Baseline, posttest (an expected average of 3 months)
measure: Plasma lipid level
timeFrame: Baseline, posttest (an expected average of 3 months)
Secondary outcomes:
measure: Change scores of Caregiver Strain Index (CSI)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Change scores of Caregiver Burden Scale(CBS)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Municipal Siaogang Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: New Taipei City
country: Taiwan
facility: Far Eastren Memorial Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Ching-yi Wu, ScD
role: PRINCIPAL_INVESTIGATOR
References: