NCT02550990

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 16, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Last Updated

December 20, 2016

Status Verified

December 1, 2016

Enrollment Period

2.9 years

First QC Date

September 6, 2015

Last Update Submit

December 19, 2016

Conditions

Stroke Patients With Cognitive Decline

Outcome Measures

Primary Outcomes (6)

  • Change scores of Montreal Cognitive Assessment (MoCA)

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

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

    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)

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

  • Change scores of Useful Field of View (UFOV)

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

  • Change scores of Stroop Color-Word test

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

  • Change scores of Dual-task test

    The dual-task tests will be assessed to determine the ability for an individual to perform 2 tasks simultaneously. The investigators will assess the dual-task performance during walking and performing box and block test. The results of the dual-task tests will provide information regarding to whether the 2 tasks compete for the same class of neural resources or one of the tasks can be carried out automatically.

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

Secondary Outcomes (19)

  • 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)

  • +14 more secondary outcomes

Study Arms (3)

Cognitive training group

ACTIVE COMPARATOR

One 60-min session of cognitive training. 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: Cognitive training

Aerobic exercise training group

ACTIVE COMPARATOR

One 60-min session of aerobic exercise training. 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

Sequential training group

EXPERIMENTAL

One 30-min session of aerobic exercise training + one 30-min session of cognitive training. 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: Sequential combination of aerobic exercise and cognitive training

Interventions

Cognitive trainingBEHAVIORAL
Cognitive training group
Aerobic exercise trainingBEHAVIORAL
Aerobic exercise training group
Sequential combination of aerobic exercise and cognitive trainingBEHAVIORAL
Sequential training group

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ischemic or hemorrhagic stroke occurring at least 6 months prior to enrollment
  • Age range from 20 to 90 years
  • MMSE score ≥ 19
  • MoCA\<26
  • Self- or informant-reported memory or cognitive complaints or CDR scale ≤ 0.5
  • Able to follow the study instruction
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Chang Gung Memorial Hospital

Kwei-Shan, Taoyuan, 333, Taiwan

RECRUITING

Chiayi Chang Gung Memorial Hospital

Chiayi City, 613, Taiwan

RECRUITING

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

RECRUITING

Keeling Chang Gung Memorial Hospital

Keelung, 204, Taiwan

RECRUITING

Taipei Chang Gung Memorial Hospital

Taipei, 105, Taiwan

RECRUITING

Taoyuan Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

RECRUITING

Related Publications (2)

  • 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.

    PMID: 35349186DERIVED

  • 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.

    PMID: 28859664DERIVED

MeSH Terms

Interventions

Cognitive Training

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Ching-Yi Wu, ScD

CONTACT

+886-3-2118800cywu@mail.cgu.edu.tw

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

September 6, 2015

First Posted

September 16, 2015

Study Start

September 1, 2015

Primary Completion

August 1, 2018

Last Updated

December 20, 2016

Record last verified: 2016-12

Locations

TW(6)