UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049529 |
|---|---|
| Receipt number | R000056398 |
| Scientific Title | Effects of complementary and alternative medicine on cognitive and physical functions of older people |
| Date of disclosure of the study information | 2022/11/16 |
| Last modified on | 2023/10/24 09:11:00 |
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Basic information
Public title
Effects of complementary and alternative medicine on cognitive and physical functions of older people
Acronym
Effects of complementary and alternative medicine on cognitive and physical functions of older people
Scientific Title
Effects of complementary and alternative medicine on cognitive and physical functions of older people
Scientific Title:Acronym
Effects of complementary and alternative medicine on cognitive and physical functions of older people
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we investigated whether the combination of complementary and alternative medicine (music and movement therapy (MMT) and heat therapy) could improve cognitive and physical functions in the older people more than the MMT program alone.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in cognitive function two months after starting complementary and alternative medicine
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Hot pack + MMT
Interventions/Control_2
MMT
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy participants
Key exclusion criteria
Those who have been stopped from participating by a doctor
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Matsunaga |
Organization
Aichi Medical University
Division name
School of Medicine
Zip code
4801195
Address
Yazakokarimata 1-1, Nagakute, Aichi
TEL
0561623311
matsunag@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Matsunaga |
Organization
Aichi Medical University
Division name
School of Medicine
Zip code
480-1195
Address
Yazakokarimata 1-1, Nagakute, Aichi
TEL
0561623311
Homepage URL
matsunag@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Aichi Medical University
Address
Yazakokarimata 1-1, Nagakute, Aichi
Tel
0561623311
matsunag@aichi-med-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 16 | 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
Main results already published
Date of protocol fixation
| 2022 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 16 | Day |
Last modified on
| 2023 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056398
