UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025550
Receipt No. 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

* 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
Email 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
Email sylee@ncgg.go.jp

Sponsor
Institute National Center for Geriatrics and Gerontology
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029396

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.