Clinical trial NCT02550990: Synergistic Effects of Aerobic Exercise and Cognitive Training on Cognition in Stroke Patients With Cognitive Decline
Official title: Synergistic Effects of Aerobic Exercise and Cognitive Training on Cognition, Physiological Markers, Daily Function and Quality of Life in Stroke Patients With Cognitive Decline
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke Patients With Cognitive Decline
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2015-09-16
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: 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.


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 ≥ 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

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: Between baseline and posttest (an expected average of 3 months)
Other outcomes:
Locations:
city: Kwei-Shan
country: Taiwan
facility: Chang Gung Memorial Hospital
state: Taoyuan
city: Chiayi City
country: Taiwan
facility: Chiayi Chang Gung Memorial Hospital
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Keelung City
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
Study officials:
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.
citation: 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.