UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057232 |
|---|---|
| Receipt number | R000065283 |
| Scientific Title | The effect of a depression improvement program using rhythmic Japanese drum exercise on Parkinson's disease patients |
| Date of disclosure of the study information | 2025/03/07 |
| Last modified on | 2026/01/18 15:03:50 |
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Basic information
Public title
The effect of a depression improvement program using rhythmic Japanese drum exercise on Parkinson's disease patients
Acronym
The effect of a depression improvement program using rhythmic Japanese drum exercise on Parkinson's disease patients
Scientific Title
The effect of a depression improvement program using rhythmic Japanese drum exercise on Parkinson's disease patients
Scientific Title:Acronym
The effect of a depression improvement program using rhythmic Japanese drum exercise on Parkinson's disease patients
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effectiveness of a depression improvement program using rhythmic Japanese drum exercise for Parkinson's disease patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
depression mental health
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Rhythmic exercise using Japanese drum music
Interventions/Control_2
No exercising
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Outpatients with Parkinson's disease
Key exclusion criteria
Those with a Mini Mental State Examination score of 20 or less
Those who are unable to follow exercise instructions due to communication difficulties, etc.
Those with severe depression who are currently receiving treatment at a specialized medical department such as a psychosomatic clinic
Those in extremely poor physical condition (terminal stage, etc.) who are unable to tolerate exercise
Those who the doctor in charge has determined to be ineligible
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | YUKAKO |
| Middle name | |
| Last name | ANDO |
Organization
Nagoya City University
Division name
Graduate School of Nursing
Zip code
4678601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku Nagoya
TEL
81-52-853-8046
yukakoa@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Yukako |
| Middle name | |
| Last name | Ando |
Organization
Nagoya City University
Division name
Graduate School of Nursing
Zip code
4678601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku Nagoya
TEL
81-52-853-8046
Homepage URL
yukakoa@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Fukushima Co-op Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City University Graduate School of Nursing Research Ethics Committee
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku Nagoya
Tel
81-52-853-8046
yukakoa@med.nagoya-cu.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
| 2025 | Year | 03 | Month | 07 | 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
| 2025 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 02 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 03 | Month | 07 | Day |
Last modified on
| 2026 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065283
