Synergistic Effects of Aerobic Exercise and Cognitive Training on Cognition in Stroke Patients With Cognitive Decline

NCT ID: NCT02550990

Last Updated: 2016-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke Patients With Cognitive Decline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Cognitive training group

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.

Group Type ACTIVE_COMPARATOR

Cognitive training

Intervention Type BEHAVIORAL

Aerobic exercise training group

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.

Group Type ACTIVE_COMPARATOR

Aerobic exercise training

Intervention Type BEHAVIORAL

Sequential training group

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.

Group Type EXPERIMENTAL

Sequential combination of aerobic exercise and cognitive training

Intervention Type BEHAVIORAL

Interventions

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Cognitive training

Intervention Type BEHAVIORAL

Aerobic exercise training

Intervention Type BEHAVIORAL

Sequential combination of aerobic exercise and cognitive training

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chang Gung Memorial Hospital

Kwei-Shan, Taoyuan, Taiwan

Site Status RECRUITING

Chiayi Chang Gung Memorial Hospital

Chiayi City, , Taiwan

Site Status RECRUITING

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status RECRUITING

Keeling Chang Gung Memorial Hospital

Keelung, , Taiwan

Site Status RECRUITING

Taipei Chang Gung Memorial Hospital

Taipei, , Taiwan

Site Status RECRUITING

Taoyuan Chang Gung Memorial Hospital

Taoyuan, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Ching-Yi Wu, ScD

Role: CONTACT

Phone: +886-3-2118800

Email: [email protected]

Facility Contacts

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Ching-Yi Wu, ScD

Role: primary

Shi-Zhe Lin, MS

Role: primary

Ku-Chou Chang, MD

Role: primary

Chia-Ling Chen, PhD

Role: primary

Chia-Ling Chen, PhD

Role: primary

Chia-Ling Chen, PhD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 35349186 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28859664 (View on PubMed)

Other Identifiers

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104-4892A3

Identifier Type: -

Identifier Source: org_study_id