Effects and Mechanism of the Sequential Combination of Exercise and Cognitive Training in Stroke Patients

NCT03045991 | Completed

• 1 other identifier: 201600871A3
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 6

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.

Conditions

Stroke Patients With Cognitive Decline

Outcome Measures

Primary Outcomes (6)

• Change scores of Montreal Cognitive Assessment (MoCA)

  The MoCA will be used to assess general cognitive functions. It examines several cognitive domains with a total score of 30

  Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

• Change scores of Wechsler Memory Scale - Third Edition (WMS-III)

  The WMS-III is a standardized and reliable neuropsychological examination tool designed to evaluate visuospatial and memory functions

  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)

  The WAIS-III is developed to measure an individual's intelligence level. It includes tests that evaluate cognitive functions in verbal comprehension, working memory, perceptual organization, and processing speed

  Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

• Change scores of Useful Field of View (UFOV)

  The UFOV assessment is a computer-based visual test containing three subtests: visuomotor processing speed, divided attention, and selective attention.

  Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

• Change scores of Stroop Color-Word test

  The Stroop Color-Word assesses the abilities of selective attention, inhibition and executive function. The participants will be tested under congruent and incongruent conditions.

  Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

• Change scores of Dual-task test

  The dual-task test evaluates the ability to shift attention between one task and another. Participants will perform the box and block test (BBT) while doing secondary cognitive tasks while sitting. Participants will perform BBT by affected and less affected hand.

  Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

Secondary Outcomes (23)

• 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)

• Change scores of Glucose indicator

  Baseline, posttest (an expected average of 3 months)

• Change scores of Plasma lipid level

  Baseline, posttest (an expected average of 3 months)

• Change scores of Functional Independence Measure (FIM)

  Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)

Study Arms (2)

sequential training group (SEQ)

EXPERIMENTAL

The sequential training group (SEQ) will first receive 30-minutes aerobic exercise training followed by 30-minutes computerized cognitive training. All participants will receive a training session for 60 minutes per day, three days per week for 12 weeks, a total of 36 training sessions. 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.

Behavioral: aerobic exercise training; Behavioral: cognitive training

control intervention group (CI)

ACTIVE COMPARATOR

The control intervention group (CI) will receive a control training session for 60 minutes per day, three days per week for 12 weeks, a total of 36 training sessions. 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.

Behavioral: control training

Interventions

aerobic exercise training BEHAVIORAL

The aerobic exercise program using progressive resistive stationary bicycle training which will contain warm-up, resistive physical exercise, and cool-down. The training resistance will increase with improvement of participants' performance.

sequential training group (SEQ)

control training BEHAVIORAL

The control training program will receive 30 minutes non-aerobic exercise training, including stretching muscle skills, joint mobility exercises; in addition to one 30-minute session of unstructured mental activities, such as reading books or reading educational films.

control intervention group (CI)

cognitive training BEHAVIORAL

The computerized cognitive training program will be implemented with the brainHQ to target abilities of visuospatial processing, attention, memory, and executive function. The level of the training program will become more difficult with progress in participants' targeted cognitive abilities.

sequential training group (SEQ)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Ischemic or hemorrhagic stroke occurring at least 6 months prior to enrollment
• MMSE score ≥ 19,MoCA\<26,able to follow the study instruction
• Self- or informant-reported memory or cognitive complaints or CDR scale ≤ 0.5
• Adequate cardiopulmonary function to perform aerobic exercise
• Able to walk with or without assistive devices

You may not qualify if:

• Unstable medical history (e.g., recent myocardial infarction) that might limit participation
• Concomitant with other neurological disorders (e.g., Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis)
• Current participation in another interventional trial

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (6)

Chiayi Chang Gung Memorial Hospital

Chiayi City, 613, Taiwan

Location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

Location

Keeling Chang Gung Memorial Hospital

Keelung, 204, Taiwan

Location

Taipei Chang Gung Memorial Hospital

Taipei, 105, Taiwan

Location

Taoyuan Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

Location

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 30639273 DERIVED

MeSH Terms

Interventions

Cognitive Training

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Ching-Yi Wu, ScD

  Chang Gung University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2016
• First Posted: February 8, 2017
• Study Start: September 1, 2016
• Primary Completion: October 16, 2019
• Study Completion: November 20, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02

Locations

TW (6)