UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031075 |
|---|---|
| Receipt number | R000035489 |
| Scientific Title | Effects of remote feedback and self-monitoring intervention using pedometer on physical activity in patients with Parkinson's disease : A pilot study |
| Date of disclosure of the study information | 2018/01/31 |
| Last modified on | 2022/02/03 10:06:43 |
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Basic information
Public title
Effects of remote feedback and self-monitoring intervention using pedometer on physical activity in patients with Parkinson's disease : A pilot study
Acronym
Effects of remote feedback and self-monitoring intervention on physical activity in patients with Parkinson's disease : A pilot study
Scientific Title
Effects of remote feedback and self-monitoring intervention using pedometer on physical activity in patients with Parkinson's disease : A pilot study
Scientific Title:Acronym
Effects of remote feedback and self-monitoring intervention on physical activity in patients with Parkinson's disease : A pilot study
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study tests the effects of remote feedback and self-management intervention on the physical activity, physical, mental function and Parkinson's symptoms in patients with Parkinson's diseases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
(1) step counts at pre and post intervention (6 month)
Key secondary outcomes
(1) indicator of Parkinson's disease symptoms (motor symptoms, non-motor symptoms)
(2) drug regimen
(3) cognitive function (attention, executive function, processing speed, etc.)
(4) physical and mental performance and physical activity
(5) psychological outcomes
(6) daily life performance outcomes
(7) biomarker
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Control group: once-monthly Provide educational information for 6 months
Interventions/Control_2
Feedback and self-monitoring group: once-monthly pedometer-based step counts goal setting (5% increase) program and Provide educational information for 6 months
Interventions/Control_3
Feedback and self-monitoring group: once-monthly pedometer-based step counts goal setting (10% increase) program and Provide educational information for 6 months
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
For those who meet all of the following
(1) Diagnosed as Parkinson's disease based on UK Parkinson's Disease Society Brain Bank criteria
(2) Stable antiparkinson drug regimen for at least 4 weeks prior to study entry
(3) Stages <=3 in the ON state for Modified Hoehn and Yahr Scale
(4) People who have given written consent
Key exclusion criteria
Exclude any person who also corresponds to one of the following
(1) History of severe neurological diseases such as dementia, visual impairment, psychiatric disorders
(2) Those who have severe cardiopulmonary disorder
(3) Walking in daily life is not independent
(4) People who are in the Investigator's judgment unlikely to comply with medical regimens or study requirements
Target sample size
45
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 Graduate School of Medicine
Division name
Department of Neurology and Neurological Science
Zip code
814-0180
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka-city, Fukuoka, Japan
TEL
092-801-1011
Homepage URL
nagaki.fukuoka.university@gmail.com
Sponsor or person
Institute
Department of Neurology, Fukuoka university
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University
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
Fukuoka university Review Board
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka-city, Fukuoka, Japan
Tel
092-801-1011
fu-merb-bigvan@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
福岡大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 01 | Month | 17 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 31 | Day |
Last modified on
| 2022 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035489
