UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039820 |
|---|---|
| Receipt number | R000045407 |
| Scientific Title | Feasibility study of health promotion activities in the community mainly by people with mild Parkinson's disease |
| Date of disclosure of the study information | 2020/03/14 |
| Last modified on | 2024/03/19 07:03:46 |
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Basic information
Public title
Feasibility of health promotion activities in the community mainly by people with mild Parkinson's disease
Acronym
Feasibility of health promotion activities by people with mild Parkinson's disease
Scientific Title
Feasibility study of health promotion activities in the community mainly by people with mild Parkinson's disease
Scientific Title:Acronym
Feasibility of health promotion activities mainly by people with mild Parkinson's disease
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate the effects, satisfaction, and continuity of community activities mainly by people with mild Parkinson's disease on psychological, mental and physical functions, and to clarify their feasibility.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Parkinson's Disease Questionnaire39
(baseline,post3months,post6months)
Key secondary outcomes
Life Space Assessment,satisfaction with health promotion activities, strength,balance, walking ability, sit to stand-5, vocalization ability and content of information shared among participants
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
1 set/month
Physical condition confirmation (5 minutes), Information exchange between participants (10 minutes), warming up exercise including stretching (10 minutes), Vocalization and oral movements (10 minutes), Posture adjustment and gymnastics (15 Minutes), cooling down exercise
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
mild Parkinson's disease
Key exclusion criteria
People who are not able to walk independently
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | SHIBA |
Organization
Fukushima Medical University
Division name
School of Health Sciences
Zip code
960-8031
Address
10-6 Sakaemachi, Fukushima, Fukushima 960-8031 Japan
TEL
024-581-5541
y-shiba@umin.ac.jp
Public contact
Name of contact person
| 1st name | wakana |
| Middle name | |
| Last name | HATA |
Organization
Kitasato University
Division name
School of Allied Health Sciences
Zip code
252-0373
Address
1-15-1 KITASATO, MINAMI-KU, SAGAMIHARA, KANAGAWA, 252-0373 JAPAN
TEL
042-778-9660
Homepage URL
hata-w@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
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
St.Marianna University, School of Medicine Toyoko Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University School of Health Sciences Research Ethics Review Committee
Address
1-15-1 KITASATO, MINAMI-KU, SAGAMIHARA, KANAGAWA, 252-0373 JAPAN
Tel
042-778-9660
hata-w@kitasato-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
| 2020 | Year | 03 | Month | 14 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2028 | 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
| 2020 | Year | 03 | Month | 14 | Day |
Last modified on
| 2024 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045407
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
