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 | 2025/04/21 16:38:01 |
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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
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
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
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
none
Publication of results
Partially published
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
72
Results
It was suggested that increasing the number of exercise therapy sessions (number of visits per year) may improve lower limb muscle mass and grip strength.
It was also suggested that consuming foods containing protein (nutritional therapy) may improve upper arm muscle mass and grip strength.
Results date posted
| 2025 | Year | 04 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Those aged 60 to 95 who undergo exercise therapy
Participant flow
Number of registered cases n=79 (male: 29 female: 50)
Preliminary examination n=74 (without nutritional therapy: 33 with nutritional therapy: 41)
6 months later n=58 (without nutritional therapy: 24 with nutritional therapy: 34)
9 months later n=51 (without nutritional therapy: 22 with nutritional therapy: 29)
3 months later n=57 (without nutritional therapy: 23 with nutritional therapy: 34)
12 months later n=56 (without nutritional therapy: 23 with nutritional therapy: 33)
Adverse events
Thirty-six adverse events occurred, but no serious adverse events occurred.
Outcome measures
Number of times (number of visits per year) that you have received exercise therapy, such as cognicise, bodyweight strength training focusing on the trunk and lower limb muscles, and individual functional training (walking training, lower limb movement training, and exercises)
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
| 2025 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039252
