UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021829 |
|---|---|
| Receipt number | R000025164 |
| Scientific Title | Effects of exercise on brain activity during walking in older adults |
| Date of disclosure of the study information | 2016/04/10 |
| Last modified on | 2016/04/07 21:26:04 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of exercise on brain activity during walking in older adults
Acronym
Effects of exercise on brain activity
Scientific Title
Effects of exercise on brain activity during walking in older adults
Scientific Title:Acronym
Effects of exercise on brain activity
Region
| Japan |
Condition
Condition
Healthy older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigated the effects of physical exercise on brain activity during walk in the healthy older adults using positron emission tomography and [18F]fluorodeoxyglucose (FDG PET) for quantitative and objective evaluation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Regional cerebral glucose metabolism after 3 months.
Key secondary outcomes
Walking speed, step length, and cadence
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Exercise
Interventions/Control_2
Physical therapy
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Inclusion criteria was older women aged 75 years and over who were registered our database.
Key exclusion criteria
Exclusion criteria were history of neurological or psychiatric disorders, cardiovascular disease, hypertension, heart failure, diabetes mellitus, head trauma, drug or alcohol abuse, or severe pain, low cognitive function (i.e., Mini Mental State Examination score < 27 points), multiple medications, drug allergy, gait disturbance, and presence of signal intensities or brain atrophy on MRI.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Shimada |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Research Team for Promoting Independence of the Elderly
Zip code
Address
35-2 Sakae-cho,Itabashi-ku,Tokyo,173-0015,Japan
TEL
03-3964-3241
shimada@tmig.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Shimada |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Preventive Gerontology
Zip code
Address
7-430 Morioka-cho, Obu, Aichi, Japan, 484-8511
TEL
0562-44-5651
Homepage URL
shimada@ncgg.go.jp
Sponsor or person
Institute
Ministry of Education and Culture of Japan
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education and Culture of Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 04 | Month | 10 | 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
Completed
Date of protocol fixation
| 2008 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 07 | Day |
Last modified on
| 2016 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025164
