UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063167 |
|---|---|
| Receipt number | R000072297 |
| Scientific Title | A Single-Case Experimental Study to Evaluate the Effectiveness of Aerobic Exercise for Aphasia Following a First-Ever Stroke |
| Date of disclosure of the study information | 2026/10/04 |
| Last modified on | 2026/10/03 22:11:48 |
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Basic information
Public title
A Study Investigating the Effects of Aerobic Exercise on Language Function in People with Aphasia Following a First-Ever Stroke
Acronym
A Study Investigating the Effects of Aerobic Exercise in People with Aphasia
Scientific Title
A Single-Case Experimental Study to Evaluate the Effectiveness of Aerobic Exercise for Aphasia Following a First-Ever Stroke
Scientific Title:Acronym
A Single-Case Experimental Study of the Effectiveness of Aerobic Exercise in People with Aphasia
Region
| Japan |
Condition
Condition
post-stroke aphasia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of combining aerobic exercise with aphasia rehabilitation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Western Aphasia Battery (WAB) - Aphasia Quotient (AQ)
Key secondary outcomes
Discourse Assessment, WAIS-IV (Symbol Search and Coding), Electroencephalography (EEG)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
An ABA design will be employed. During the A phase, participants will receive one hour of language rehabilitation provided by a speech-language pathologist (SLP), at least five days per week. During the B phase, participants will perform aerobic exercise, followed within 10 minutes by one hour of language rehabilitation provided by a speech-language pathologist (SLP), at least five days per week.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
* At least 3 months after stroke onset.
* Left cerebral hemisphere lesion.
* Individuals with aphasia, excluding those with the most severe aphasia (Western Aphasia Battery (WAB) Aphasia Quotient (AQ) between 31.4 and 91.7).
* Age 20-80 years.
* Ability to achieve the target exercise intensity.
Key exclusion criteria
* Individuals with marked intellectual impairment (Raven's Colored Progressive Matrices score <= 2 SD below the mean for the same age group).
* Individuals whom a speech-language pathologist (SLP) judges to have difficulty understanding the study procedures and explanations.
* Individuals with severe hearing or visual impairment that cannot be adequately corrected.
* Individuals who have difficulty performing the bicycle ergometer exercise due to severe motor paralysis, arrhythmia, use of beta-blockers, or other exercise limitations.
* Individuals taking medications, such as antiepileptic drugs, that may affect electroencephalographic (EEG) activity.
* Individuals with a history of traumatic brain injury, brain tumor, psychiatric disorder, or epilepsy.
* Individuals with a resting systolic blood pressure >= 180 mmHg and/or diastolic blood pressure >= 110 mmHg, or a resting heart rate >= 110 beats/min.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Michiyuki |
| Middle name | |
| Last name | Kawakami |
Organization
Keio University
Division name
Department of Rehabilitation Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3833
michiyukikawakami@hotmail.com
Public contact
Name of contact person
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Takatsu |
Organization
Keio University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3833
Homepage URL
lang.nobu@gmail.com
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Kawakami Michiyuki
Funding Source
Organization
Keio University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
03-5363-3611
keio@esct.bvits.com
Secondary IDs
Secondary IDs
YES
Study ID_1
20261111
Org. issuing International ID_1
Keio University School of Medicine Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 03 | Day |
Last modified on
| 2026 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072297
