UMIN-CTR Clinical Trial

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
Email	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
Email	nagaki.fukuoka.university@gmail.com

Sponsor
Institute	Department of Neurology, Fukuoka university
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035489