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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034458
Receipt No. R000039252
Scientific Title Prospective observational study of users of ARFIT which services ambulatory rehabilitation on body composition, motor function, cognitive function, depression, quality of life, fall and fracture event.
Date of disclosure of the study information 2018/10/15
Last modified on 2019/05/27

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Basic information
Public title Prospective observational study of users of ARFIT which services ambulatory rehabilitation on body composition, motor function, cognitive function, depression, quality of life, fall and fracture event.
Acronym Prospective observational study of users of ARFIT which services ambulatory rehabilitation on body composition, motor function, cognitive function, depression, quality of life, fall and fracture event.
Scientific Title Prospective observational study of users of ARFIT which services ambulatory rehabilitation on body composition, motor function, cognitive function, depression, quality of life, fall and fracture event.
Scientific Title:Acronym Prospective observational study of users of ARFIT which services ambulatory rehabilitation on body composition, motor function, cognitive function, depression, quality of life, fall and fracture event.
Region
Japan

Condition
Condition Certified person of needed support and long-term care.
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to examine relevance between exercise therapy and nutrition therapy implementation status and body composition, motor function, cognitive function, depression, quality of life, fall and fracture event.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes skeletal muscle mass
Key secondary outcomes height, body weight, BMI, SMI, body fat percentage, bone mineral mass, time up and go test, 5-meter walk test, grip strength, one-leg stand test, 5-times chair stand test, MMSE-J, HDS-R, GDS-15-J, PGC-MS, fall event, fracture event, BDHQL, adverse event.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
60 years-old <=
Age-upper limit
95 years-old >
Gender Male and Female
Key inclusion criteria 1)Japanese males and females aged 60 to 95 years.
2)Certified subjects of needed support and long-term care.
3)Subjects who received a sufficient explanation about the purpose and content of this study and can agree to participation in writing or who have no ability to agree can obtain consent from family members.
Key exclusion criteria 1)Subjects who take high protein foods such as protein supplements or who intend to intake in the future.
2)Subjects who are participating other clinical study, planning to participate in the future or have not passed 3 months after joining other clinical study.
3)Subjects who are embedding cardiac pacemaker or defibrillator.
4)Subjects who are judged inappropriate by research investigators.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Togo
Organization Minorikai Medical Corporation
Inaho Clinic
Division name The chairperson of the Minorai Medical Coporation
Zip code
Address 2F, Yokodai Suzuki Bldg., Yokodai 5-1-35, Yokohama 236-0053, Kanagawa, Japan
TEL 045-489-4480
Email togo.takashi@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Takeuchi
Organization INSEAC, Inc
Division name Chief Executive Officer
Zip code
Address 2-7-2 Hongodai, Sakae-ku, Yokohama, Kanagawa, Japan
TEL 045-435-5446
Homepage URL
Email htakeuchi@inseac.co.jp

Sponsor
Institute INSEAC, Inc
Institute
Department

Funding Source
Organization FANCL Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 株式会社インシーク ARFIT(神奈川県)

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 15 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 Open public recruiting
Date of protocol fixation
2018 Year 10 Month 01 Day
Date of IRB
2018 Year 09 Month 20 Day
Anticipated trial start date
2018 Year 10 Month 30 Day
Last follow-up date
2021 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observe one year for those who use ARFIT and meet eligibility criteria from October 1, 2018 to March 31, 2020.

Management information
Registered date
2018 Year 10 Month 12 Day
Last modified on
2019 Year 05 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039252

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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