UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034458
Receipt number 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 2023/04/17 11:56:01

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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 Takashi
Middle name
Last name Togo

Organization

Minorikai Medical Corporation
Inaho Clinic

Division name

The chairperson of the Minorai Medical Coporation

Zip code

235-0045

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 Hiroshi
Middle name
Last name Takeuchi

Organization

INSEAC, Inc

Division name

Chief Executive Officer

Zip code

247-0008

Address

2-7-2 Hongodai, Sakae-ku, Yokohama, Kanagawa, Japan

TEL

045-435-5446

Homepage URL


Email

htakeuchi@inseac.co.jp


Sponsor or person

Institute

INSEAC, Inc

Institute

Department

Personal name



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

Clinical Research Ethics Committee of FANCL Corporation

Address

12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa

Tel

045-820-3657

Email

akihide_nisihara@fancl.co.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

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

No longer 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

2023 Year 12 Month 31 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 September 30, 2022.


Management information

Registered date

2018 Year 10 Month 12 Day

Last modified on

2023 Year 04 Month 17 Day



Link to view the page

Value
https://center6.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