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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033206
Receipt No. R000035740
Scientific Title Consideration of appropriate exercise load in physical frailty patients
Date of disclosure of the study information 2018/06/29
Last modified on 2020/10/03

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Basic information
Public title Consideration of appropriate exercise load in physical frailty patients
Acronym Consideration of appropriate exercise load in physical frailty patients
Scientific Title Consideration of appropriate exercise load in physical frailty patients
Scientific Title:Acronym Consideration of appropriate exercise load in physical frailty patients
Region
Japan

Condition
Condition physical fraility patients
Classification by specialty
Geriatrics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose is to clarify the amount of load (strength, number of iterations, number of sets) as much as possible as a certain standard necessary for the escape of frail.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes usual walking speed(10m walk)
Key secondary outcomes Fraility improvement(J-CHS,SPPB)
Isometric knee extension strength

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 1.Normal rehabilitation program
2.Isotonic knee extension exercise with 60%1RM strength, 20 iterations and 3sets

For 60 minutes exercise time, seven times per week, 12 weeks period
Interventions/Control_2 1.Normal rehabilitation program

For 60 minutes exercise time, seven times per week, 12 weeks period
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Physical flail was judged to be a physical flare in Japanese version of CHS standard (hereinafter referred to as J - CHS standard) (three or more items out of 5 items of weight loss, easy fatigability, decreased activity, walking speed decrease, muscle strength decrease) , Those who need support 2 or more. Persons who have passed more than 14 days from the onset date. He is a person who can walk.
Key exclusion criteria Persons with severe cognitive decline, higher brain dysfunction, those with mental illness, those who are fractured, neurological disorders, acute inflammatory diseases, tumor growth, users of immunomodulators, gait impossible Person who is in the middle of the intervention and whose condition worsens and the movement ceased.
Target sample size 36

Research contact person
Name of lead principal investigator
1st name Ryo
Middle name
Last name Uchida
Organization Social Medical Corporation Corporate Taisei Nagashio Hospital
Division name Department of Rehabilitation
Zip code 170-0014
Address 1-5-8,IkebukuroT,oshimaku,Tokyo
TEL 03-3984-6161
Email nagashiopt@gmail.com

Public contact
Name of contact person
1st name Ryo
Middle name
Last name Uchida
Organization Social Medical Corporation Corporate Taisei Nagashio Hospital
Division name Department of Rehabilitation
Zip code 170-0014
Address 1-5-8,Ikebukuro,Toshimaku,Tokyo
TEL 03-3984-6161
Homepage URL
Email nagashiopt@gmail.com

Sponsor
Institute Social Medical Corporation Corporate Taisei Nagasio Hospital
Institute
Department

Funding Source
Organization None
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 Social Medical Corporation Corporate Taisei Nagasio Hospital
Address 1-5-8,Ikebukuro,Toshimaku,Tokyo
Tel 03-3984-6161
Email ucchi824@gmail.com

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 長汐病院(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 29 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 Completed
Date of protocol fixation
2018 Year 06 Month 01 Day
Date of IRB
2018 Year 06 Month 25 Day
Anticipated trial start date
2018 Year 11 Month 01 Day
Last follow-up date
2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 06 Month 29 Day
Last modified on
2020 Year 10 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035740

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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