UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056171 |
|---|---|
| Receipt number | R000064171 |
| Scientific Title | A randomized crossover design trial to evaluate the efficacy of aerobic exercise for aphasia after first time stroke |
| Date of disclosure of the study information | 2024/11/18 |
| Last modified on | 2025/05/18 15:00:38 |
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Basic information
Public title
A study on the efficacy of aerobic exercise in aphasia
Acronym
A study on the efficacy of aerobic exercise in aphasia
Scientific Title
A randomized crossover design trial to evaluate the efficacy of aerobic exercise for aphasia after first time stroke
Scientific Title:Acronym
A crossover design study of the efficacy of aerobic exercise in aphasia
Region
| Japan |
Condition
Condition
Aphasia after the first time stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine if aerobic exercise can create a neural activity ideal for aphasia recovery and improve language function in aphasic individuals.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Language function immediately after aerobic exercise
Key secondary outcomes
EEG, attentional function
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Aerobic exercise
Interventions/Control_2
Passive range of motion exercise
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
1 month or more after first stroke, aphasia due to left hemisphere damage (WAB AQ between 91.7 to 31.4)
Key exclusion criteria
RCPM test scores below -2 SD average for the same age group, significant hearing or vision loss that is difficult to correct, severe motor paralysis or atrial fibrillation, limitation of exercise due to taking beta blockers or other medications that may affect EEG, such as antiepileptic drugs, head trauma, brain tumor, mental illness, and those with a history of epilepsy.
Target sample size
43
Research contact person
Name of lead principal investigator
| 1st name | Michiyuki |
| Middle name | |
| Last name | Kawakami |
Organization
Keio University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
160-8582
Address
35, Shinanomachi, Shinjuku, Tokyo
TEL
03-3353-1211
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, Tokyo
TEL
03-3353-1211
Homepage URL
lang.nobu@gmail.com
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Nobuhiro Takatsu
Funding Source
Organization
Daiwa Securities Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo bay rehabilitation hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35, Shinanomachi, Shinjuku, Tokyo
Tel
03-3353-1211
keio@esct.bvits.com
Secondary IDs
Secondary IDs
YES
Study ID_1
20241120
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
慶應義塾大学病院（東京都）、東京湾岸リハビリテーション病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 18 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 11 | Month | 14 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 01 | 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
| 2024 | Year | 11 | Month | 17 | Day |
Last modified on
| 2025 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064171
