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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036888
Receipt No. R000024806
Scientific Title Multi-component cognitive intervention with physical exercise for older adults with Alzheimer's disease: a 6-month randomized controlled trial
Date of disclosure of the study information 2019/05/30
Last modified on 2019/05/29

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Basic information
Public title Multi-component cognitive intervention with physical exercise for older adults with Alzheimer's disease: a 6-month randomized controlled trial
Acronym Exercise improves cognition in Alzheimer's disease
Scientific Title Multi-component cognitive intervention with physical exercise for older adults with Alzheimer's disease: a 6-month randomized controlled trial
Scientific Title:Acronym Exercise improves cognition in Alzheimer's disease
Region
Asia(except Japan)

Condition
Condition Alzheimer's disease
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aimed to investigate the influence of a 6-month multi-component cognitive program (MCP) on the cognitive function of patients with moderate to severe Alzheimer disease (AD), and whether a MCP with physical exercise benefits cognitive and physical function.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes ADAS-cog(Alzheimer's disease assessment scale cognitive subscale)
Key secondary outcomes Assessment of cognitive function
1. MMSE(Mini Mental State Examination)
2. CDT(Clock Drawing Test)

Assessment of physical function
1. BBS(Berg balance scale)
2. FSST(Four square step test)
3. TUG(Timed up and go test)
5. 5MWT(5-meter walk test)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Behavior,custom
Interventions/Control_1 Intervention group
A 6-month Multi-component cognitive program(MCP) consisting of music therapy, art therapy, horticulture therapy, handicraft, recreational therapy, gymnastics, laughing therapy, and activity therapy was conducted by each therapist for 60 minutes per time, 2 times per day, 5 days per week for 6 months. Moreover, Kohzuki Exercise Program(KEP) was performed 60 minutes of supervised exercise sessions 5 times a week for 6-month.
Interventions/Control_2 Control group
A 6-month MCP alone. MCP was conducted for 60 minutes per time, 2 times per day, 5 days per week for 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. A diagnosis of AD by a neurologist
2. Living in a nursing home for at least three months
3. Moderate to severe AD as determined by their baseline MMSE score of =< 20
4. Informed consent
Key exclusion criteria 1. Not meeting inclusion criteria
2. A serious neurological diagnosis or severe cardiac, pulmonary, and musculoskeletal disorders from physician
3. Regular participation in aerobic exercise or strength training.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Ji
Middle name Min
Last name Kim
Organization Tohoku University Graduate school
Division name Department of Internal Medicine and Rehabilitation Science
Zip code 9808574
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL 022-717-7353
Email seraphina0414@gmail.com

Public contact
Name of contact person
1st name Ji
Middle name Min
Last name Kim
Organization Tohoku University Graduate school
Division name Department of Internal Medicine and Rehabilitation Science
Zip code 9808574
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL 022-717-7353
Homepage URL
Email seraphina0414@gmail.com

Sponsor
Institute Tohoku University Graduate school, Department of Internal Medicine and Rehabilitation Science
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tohoku University Graduate school
Address Department of Internal Medicine and Rehabilitation Science
Tel 022-717-7353
Email seraphina0414@gmail.com

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
2019 Year 05 Month 30 Day

Related information
URL releasing protocol https://www.karger.com/Article/FullText/446508
Publication of results Published

Result
URL related to results and publications https://www.karger.com/Article/FullText/446508
Number of participants that the trial has enrolled 33
Results
In all cognitive measures, there were no significant improvements between the two groups after 6 months in the baseline value-adjusted primary analysis. However, the ADAS-cog score was significantly lower between the two groups in secondary analysis adjusted for baseline value, age, sex, and education years. All physical outcomes were significantly higher in the intervention group except for total load compared with baseline measurements.
Results date posted
2019 Year 05 Month 29 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants included older adults with moderate to severe Alzheimer's Disease living in a nursing home in Seoul, Republic of Korea
Participant flow
Thirty-eight participants were randomized to participate in the KEP+MCP and MCP only. Of the 19 participants in the KEP+MCP group,1 participant died of pneumonia and 1 participant dropped out due to change of institution. Of the 19 participants in the MCP group, 5 participants refused to undergo baseline assessment. Thirty-three participants were assessed at 6 months after the intervention: 19 in the KEP+MCP group and 14 in the MCP group. 
Adverse events
none
Outcome measures
the Alzheimer's Disease Assessment Scale-Cognitive Subscale
Mini-Mental State Examination
Clock Drawing Test
exercise time
the number of pedal rotation
total load
grip strength
Berg Balance Scale 
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 11 Month 01 Day
Date of IRB
2014 Year 09 Month 30 Day
Anticipated trial start date
2014 Year 11 Month 10 Day
Last follow-up date
2015 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 05 Month 29 Day
Last modified on
2019 Year 05 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024806

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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