UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050789 |
|---|---|
| Receipt number | R000057869 |
| Scientific Title | Aerobic Exercise on BDNF, Upper Limb Function, Activity, and Cognitive Function in Stroke Patients |
| Date of disclosure of the study information | 2023/04/08 |
| Last modified on | 2025/04/11 14:37:40 |
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Basic information
Public title
Effects of Aerobic Exercise on Upper Limb function, Activity and Cognitive Function in Stroke Patients
Acronym
Aerobic exercise for upper limb and cognitive function
Scientific Title
Aerobic Exercise on BDNF, Upper Limb Function, Activity, and Cognitive Function in Stroke Patients
Scientific Title:Acronym
Effect of Aerobic Exercise on Stroke Patients
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify whether the combined use of aerobic exercise and rehabilitation in patients with first stroke in the subacute phase is effective in improving the function of the paralyzed upper limb and activities using the paralyzed upper limb by increasing the amount of brain-derived neurotrophic factor (BDNF). In addition, we confirm the effects of aerobic exercise on cognitive and attentional functions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fugl Meyer Assessment
Action Research Arm Test
Motricity index
Modified Ashworth Scale
10 meter walk test
modified Rankin Scale
Semmes Weinstein Monofilaments Test
Mini Mental Atate Examination Japanese
Trail Making Test Part A B Moss Attention Rating Scale
Motor Activity Log
Functional Independence Measure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
In addition to the usual rehabilitation, the patients will receive aerobic exercise for 40 minutes at 60% intensity using the Karvonen method, 5 times a week for 4 weeks.
Interventions/Control_2
In addition to the useal rehabilitation, 40 minutes of stretching 5 times a week for 4 weeks.
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients between 18 and 85 years of age with motor paralysis in one upper or lower extremity at least 3 months after the onset of the first stroke. Patients who are able to perform aerobic exercise for 40 minutes at 60% intensity using the Karvonen method of lower limb pedaling safely in a seated position.
Key exclusion criteria
Transient ischemic attack
Subarachnoid hemorrhage or lesion under the tent
Higher brain dysfunction or cognitive impairment with difficulty understanding tasks
Severe cardiac or respiratory disease
Suspected deep vein thrombosis
Exercise is prohibited or restricted by the attending physician
Neurological or psychiatric impairment
Terminally ill
Taking beta-blockers
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Hayashi |
Organization
Seijoh university
Division name
Dept. of Rehabilitation
Zip code
476-8588
Address
2-172, Fukinodai, Tokai, Aichi
TEL
052-601-6000
hayashi-h@seijoh-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Hayashi |
Organization
Seijoh university
Division name
Dept. of Rehabilitation
Zip code
476-8588
Address
2-172, Fukinodai, Tokai, Aichi
TEL
052-601-6000
Homepage URL
hayashi-h@seijoh-u.ac.jp
Sponsor or person
Institute
Seijoh university
Institute
Department
Personal name
Funding Source
Organization
ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Seijoh university
Address
2-172, Fukinodai, Toukai, Aichi
Tel
052-601-6000
kenkyu-rinri@seijoh-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2027 | 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
| 2023 | Year | 04 | Month | 08 | Day |
Last modified on
| 2025 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057869
