UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036888 |
|---|---|
| Receipt number | 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 18:04:22 |
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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
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
seraphina0414@gmail.com
Sponsor or person
Institute
Tohoku University Graduate school, Department of Internal Medicine and Rehabilitation Science
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024806
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