UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000028121
Receipt No. R000031954
Scientific Title Study on influence of locomotive syndrome on health
Date of disclosure of the study information 2017/07/07
Last modified on 2020/07/09 (Ver. 9)

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Basic information
Public title Study on influence of locomotive syndrome on health
Acronym Study on influence of locomotive syndrome on health
Scientific Title Study on influence of locomotive syndrome on health
Scientific Title:Acronym Study on influence of locomotive syndrome on health
Region
Japan

Condition
Condition Healthy Adults
Classification by specialty
Orthopedics Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Locomotive syndrome (hereinafter referred to as LOCOMO) is considered to be in a state of high risk of requiring nursing care as the motor function decrease due to the disorder of locomotive organ.
In this research, the aim is to clarify factors causing motor function deterioration, to clarify the relationship between degree of motor function decline and nursing care risk, and to obtain basic data that contributes to effective LOCOMO countermeasures.

Basic objectives2 Others
Basic objectives -Others this research will be executed as the academic study activities as the aim gaining new knowledge in the LOCOMO field.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Construct evidence of intervention effect on LOCOMO

Key secondary outcomes Collection of basic data in LOCOMO research

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 Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 At the same time doing physical fitness measurement and locomotion test on volunteers aged 20 years or older who got research consent, instruct LOCOMO training (hereinafter referred to LOCOTORE) and let them continue LOCOTORE as long as possible for 3 to 12 months, measure the same items after 3, 6, 9 and 12 months and verify the effect of LOCOTORE.
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 Subject
Volunteers who wish to participate in LOCOMO enlightenment activities tackled by facilities participating in this research

Selection Criteria
1.Volunteers are 20 years of age or older at the time of consent acquisition
2.Volunteers who were confirmed about exerciser disease and other past medical history and had no obstacle to motor function
3.Volunteers who obtain documents consent by free will after sufficient understandings as receiving the sufficient explanation upon participation in this research,
Key exclusion criteria 1.Volunteers who are not be able to obtain consent from the principal about using data in this research
2.Volunteers who are not able to walk independently
3.Volunteers who are not able to fill out questionnaire by themselves
4.Volunteers who are not able to fully understand the instruction and
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name Etsuo
Middle name
Last name Chosa
Organization University of Miyazaki Hospital
Division name Department of Orhtopaedics, Faculty of Medicine
Zip code 889-1692
Address 5200 Kihara, Kiyotake, Miyazaki 889-1692, JAPAN
TEL 0985-85-0986
Email seikei@med.miyazaki-u.ac.jp

Public contact
Name of contact person
1st name Etsuo
Middle name
Last name Chosa
Organization University of Miyazaki Hospital
Division name Department of Orhtopaedics, Faculty of Medicine
Zip code 889-1692
Address 5200 Kihara, Kiyotake, Miyazaki 889-1692, JAPAN
TEL 0985-85-0986
Homepage URL
Email seikei@med.miyazaki-u.ac.jp

Sponsor
Institute University of Miyazaki Hospital
Department of Orhtopaedics, Faculty of Medicine
Institute
Department

Funding Source
Organization University of Miyazaki Hospital
Department of Orhtopaedics, Faculty of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Miyazaki University
Address 5200 Kihara Kiyotake Miyazaki
Tel 0985-85-0986
Email seikei@med.miyazaki-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
2017 Year 07 Month 07 Day

Related information
URL releasing protocol no publication
Publication of results Unpublished

Result
URL related to results and publications no publicaton
Number of participants that the trial has enrolled 0
Results 
No result.
Results date posted
2020 Year 04 Month 15 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
no results.
Participant flow 
no results.
Adverse events 
no results.
Outcome measures 
no results.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 08 Month 07 Day
Date of IRB
2018 Year 03 Month 06 Day
Anticipated trial start date
2018 Year 03 Month 06 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 07 Month 07 Day
Last modified on
2020 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031954