UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047341 |
|---|---|
| Receipt number | R000053992 |
| Scientific Title | Randomized controlled trial of the efficacy and feasibility of a mHealth-type dance program for people with Parkinson's disease. |
| Date of disclosure of the study information | 2022/03/31 |
| Last modified on | 2022/10/26 00:23:53 |
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Basic information
Public title
Randomized controlled trial of the efficacy and feasibility of a mHealth-type dance program for people with Parkinson's disease.
Acronym
Randomized controlled trial of the efficacy and feasibility of a mHealth-type dance program for people with Parkinson's disease.
Scientific Title
Randomized controlled trial of the efficacy and feasibility of a mHealth-type dance program for people with Parkinson's disease.
Scientific Title:Acronym
Randomized controlled trial of the efficacy and feasibility of a mHealth-type dance program for people with Parkinson's disease.
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and feasibility of mHealth-type dance programs for persons with Parkinson's disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Short Physical Performance Battery
(Intervention period 8 weeks)
Key secondary outcomes
MDS-Unified Parkinsons Disease Rating Scale part III
Parkinsons Disease Questionnaire-39
Gait (speed, stride, cadence, etc.)
Beck Depression Inventory-II
Satisfaction With Life Scale
Acceptability
Feasibility
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The dance exercise group will have one online lesson per week with a coach, 60 minutes (see Appendix for details) and 30 minutes of video dance (movement review and lesson) as a home trainer to perform the exercises.
Interventions/Control_2
The active control group was instructed to perform stretching, flexibility, and relaxation exercises (excluding strength, balance, aerobic, and functional training) three times a week for 30 minutes per session. These exercises were selected from several physical therapy programs created for persons with Parkinson's disease.
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
| 30 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who meet the PD diagnostic criteria for MDS.
H&Y 1-3
Key exclusion criteria
Those who have changed their medication in the past month.
Those who have difficulty walking
Neurological, orthopedic, and/or cardiovascular conditions that render them unfit to perform dance exercise or resistance training.
Those who score less than 24/30 on the MMSE
Those who do not have access to the Internet at home.
In case you or your support person have difficulty in operating mHealth.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshio |
| Middle name | |
| Last name | Tsuboi |
Organization
Fukuoka University
Division name
Department of Neurology
Zip code
814-0180
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka-city, Fukuoka, Japan
TEL
092-801-1011
tsuboi@cis.fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Nagaki |
Organization
Fukuoka University
Division name
Department of Neurology
Zip code
814-0180
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka-city, Fukuoka, Japan
TEL
092-801-1011
Homepage URL
nagaki@fukuoka-u.ac.jp
Sponsor or person
Institute
Department of Neurology, Fukuoka university
Institute
Department
Personal name
Funding Source
Organization
Fukuoka university
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
The Clinical Research Promotion Foundation
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka University Medical Ethics Committee
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka-city, Fukuoka, Japan
Tel
092-801-1011
fumed-ethics@fukuoka-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 | 03 | Month | 31 | 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
| 2022 | Year | 04 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 21 | Day |
Last follow-up date
| 2023 | 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 | 03 | Month | 31 | Day |
Last modified on
| 2022 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053992
