Clinical trial NCT03230253: Effects and Mechanism of Two Hybrid Exercise-cognitive Trainings in Mild Ischemic Stroke With Cognitive Decline
Official title: Effects and Mechanism of Two Hybrid Exercise-cognitive Trainings in Mild Ischemic Stroke With Cognitive Decline: fMRI for Brain Plasticity, and Biomarker and Behavioral Analysis
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: 2017-07-26
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purposes are to: (1) examine and compare the effects of two hybrid interventions on brain plasticity, physiological biomarkers and behavioral outcomes, including cognitive and physical functions, from pre- to post-training; (2) understand the neural mechanisms of cognitive recovery following two hybrid interventions using the functional magnetic resonance imaging (fMRI); (3) examine the long-term benefits of the two hybrid therapies; (4) to identify the correlations between brain activity, biomarkers and behavioral measures.

Detailed description: Cognitive decline after stroke is highly associated with functional disability. Empirical evidence shows that exercise combined cognitive training may induce neuroplastic changes that modulate cognitive function. However, it is unclear whether hybridized exercise-cognitive trainings can facilitate cortical activity and physiological outcome measures and further influence on the cognitive function after stroke. We aim to investigate the effects of two hybridized exercise-cognitive trainings on brain plasticity, physiological biomarkers and behavioral outcomes in stroke survivors with cognitive decline. This study is a single-blind randomized controlled trial. A target sample size of 75 participants will be recruited. Stroke survivors with mild cognitive decline will be stratified by Mini-Mental State Examination scores and then randomized 1:1:1 to sequential exercise-cognitive training, dual-task exercise-cognitive training or control groups. All groups will undergo trainings 60 min/day, 3 days/week, for a total of 12 weeks. The primary outcome is the resting-state functional connectivity and neural activation in the frontal, parietal and occipital lobes in functional magnetic resonance imaging. Secondary outcomes include physiological biomarkers, cognitive functions, physical function, daily functions and quality of life.

This study may differentiate the effects of two hybridized trainings on cognitive function and health-related conditions and detect appropriate neurological and physiological indices to predict training effects. This study capitalizes on the groundwork for non-pharmacological intervention of cognitive decline after stroke.

Eligibility criteria: Inclusion Criteria:

1. Stroke occurring at least 6 months prior to enrollment
2. Age range from 20 to 80 years
3. MMSE score \< 28 or MoCA\<25
4. Able to follow the study instruction
5. Adequate cardiopulmonary function to perform aerobic exercise
6. 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
4. Any contraindication to MRI (metallic implants, claustrophobia, seizure, pacemakers, et al)
5. Pregnant woman

Primary outcomes:
measure: fMRI (change is being assessed)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months).
Secondary outcomes:
measure: Serum BDNF level
timeFrame: Baseline, posttest (an expected average of 3 months)
measure: Antioxidative marker
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)
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Wechsler Memory Scale - Third Edition (WMS-III)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Useful Field of View (UFOV)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Stroop Color-Word test
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Dual-task test
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Time up and go test (TUG)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Six-minute walk test (6MWT)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: International Physical Activity Questionnaires (IPAQ)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Fugl-Meyer Assessment (FMA)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Rivermead Mobility Index (RMI)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Muscle strength
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Mobility level
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Functional Independence Measure (FIM)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Lawton Instrumental Activities of Daily Living Scale (Lawton LADL)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Stroke Impact Scale (SIS)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: Caregiver Burden Scale (CB scale)
timeFrame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
measure: EuroQol-5D questionnaire (EQ-5D)
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
Study officials:
affiliation: Chang Gung University
name: Ching-yi Wu, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.