UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053937 |
|---|---|
| Receipt number | R000061564 |
| Scientific Title | The effects of circuit training on cognitive function in healthy individuals |
| Date of disclosure of the study information | 2024/03/21 |
| Last modified on | 2024/03/22 09:28:37 |
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Basic information
Public title
The effects of circuit training on cognitive function in healthy individuals
Acronym
The effects of circuit training on cognitive function
Scientific Title
The effects of circuit training on cognitive function in healthy individuals
Scientific Title:Acronym
The effects of circuit training on cognitive function
Region
| Japan |
Condition
Condition
healthy individual
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify how cognitive function changes through habitual exercise (circuit training: resistance training, aerobic exercise, stretching)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Healthy female participants aged 40 to 74 were subjected to 16 weeks of circuit training, with the aim of comparing changes in cognitive function between the circuit exercise group and the control group.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Circuit exercises were conducted 2 to 3 times per week for 16 weeks.
Interventions/Control_2
Continuing with their usual lifestyle without engaging in active 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
| 40 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Female
Key inclusion criteria
(1) Age between 40 and under 75 years old (at the time of registration)
(2) Gender: Only females
(3) Individuals who can continue exercising 2 to 3 times a week for 4 months during the study period
(4) Individuals who can provide written consent to participate in the study
Key exclusion criteria
(1) Individuals who cannot obtain informed consent
(2) Individuals with a history of dementia or neurological diseases
(3) Individuals with the following serious diseases or taking medication that could cause such diseases, which will be checked during the consent explanation by the study collaborator:
1. Individuals with a history or current condition of:
Kidney impairment (including severe chronic kidney disease)
Liver impairment
Heart disease
Severe hypertension (systolic blood pressure above 180 mmHg and diastolic blood pressure above 110 mmHg)
Stroke
Mental illness
Epilepsy
Immune diseases
Multiple sclerosis
Systemic lupus erythematosus (SLE)
2. Individuals taking the following medication:
Antiepileptic drugs
Antidepressants
Antipsychotics
Antiarrhythmic drugs
(4) Individuals with severe visual or auditory impairments
(5) Individuals who regularly exercise at sports gyms or clubs
(6) Pregnant or breastfeeding individuals
(7) Individuals participating in other clinical studies (including studies involving exercise intervention or cognitive function tests)
(8) Others who may have difficulty completing the study
(9) Individuals affiliated with the department (including dual appointments) of the study director and co-researchers (students, graduate students, and staff, etc.)
(10) Individuals with claustrophobia
(11) Individuals with metal implants in their body
Target sample size
96
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Taki |
Organization
Tohoku University
Division name
Smart Aging International Research Center
Zip code
980-8575
Address
4-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-8582
yasuyuki.taki.c7@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Keishi |
| Middle name | |
| Last name | Soga |
Organization
Tohoku University
Division name
Smart Aging International Research Center
Zip code
980-8575
Address
4-1 Seiryo-Machi, Aoba-ku,Sendai
TEL
022-717-8952
Homepage URL
keishi.soga.b4@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Curves Japan CO.,LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Tohoku University Graduate School of Medicine
Address
2-1, Seiryo-machi, Aoba-ku, Sendai
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2024 | Year | 03 | Month | 21 | 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
| 2024 | Year | 03 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 30 | 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 | 03 | Month | 21 | Day |
Last modified on
| 2024 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061564
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| Registered date | File name |
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