UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025550 |
|---|---|
| Receipt number | R000029396 |
| Scientific Title | The effects of ergometer intervention combining physical and cognitive training in older adults with mild cognitive impairment (MCI): A randomized control trial |
| Date of disclosure of the study information | 2017/01/10 |
| Last modified on | 2019/07/11 19:18:30 |
* 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
The effects of ergometer intervention combining physical and cognitive training in older adults with mild cognitive impairment (MCI): A randomized control trial
Acronym
Intervention study of the effects of combined physical and cognitive training
Scientific Title
The effects of ergometer intervention combining physical and cognitive training in older adults with mild cognitive impairment (MCI): A randomized control trial
Scientific Title:Acronym
Intervention study of the effects of combined physical and cognitive training
Region
| Japan |
Condition
Condition
Mild Cognitive Impairment
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether combined physical and cognitive training using an ergometer is useful for improving cognition in older adults with MCI
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Logical memory, Word list memory, Digit span, Modified digit symbol substitution test, Modified trail making test, and Working memory
Key secondary outcomes
Neuroimaging method: Magnetic Resonance Imaging (MRI)
Physical function: G rip strength, Gait, Anthropometry, Body composition
Cognitive function: Mini-Mental State Examination (MMSE)
Activities of daily living: Kihon checklist, Instrumental Activities of Daily Living (IADL)
Psychological function: Quality of Life (QOL) , Geriatric Depression Scale (GDS), Life satisfaction
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Intervention group: Combined physical and cognitive training using an ergometer for older adults with MCI, taking place in 48 sessions over 6 months
Interventions/Control_2
Control group: Lectures on health for older adults with MCI, taking place in 2 sessions over 6 months
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Adults aged 65 years and over, who have participated in the National Center for Geriatrics and Gerontology Study of Geriatric Syndromes (NCGG-SGS)
2) Japanese native speakers with suspected MCI
3) Mini-Mental State Examination (MMSE) score of 24 and over
4) Informed written consent
Key exclusion criteria
1)Potential participation in other project
2)Parkinson's disease
3)Depression
4)Dementia
5)Collagen disease
6)Use of a pacemaker
7)Medically advised not to participate in exercise
8)Death and moving out after NCGG-SGS
9)Use of long-term care insurance
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Shimada |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Preventive Gerontology
Zip code
474-8511
Address
7-430 Morioka-cho, Obu City, Aichi Prefecture
TEL
0562-44-5651
shimada@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Sangyoon |
| Middle name | |
| Last name | Lee |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Preventive Gerontology
Zip code
474-8511
Address
7-430 Morioka-cho, Obu City, Aichi Prefecture
TEL
0562-45-5638
Homepage URL
sylee@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
National Center for Geriatrics and Gerontology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Inter Reha Co.,Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Geriatrics and Gerontology
Address
7-430 Morioka-cho, Obu City, Aichi Prefecture
Tel
0562-44-5651
sumiyami@ncgg.go.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
国立研究開発法人国立長寿医療研究センター(National Center for Geriatrics and Gerontology)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 05 | Day |
Last modified on
| 2019 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029396
