UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033206 |
|---|---|
| Receipt number | 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 10:50:58 |
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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
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
nagashiopt@gmail.com
Sponsor or person
Institute
Social Medical Corporation Corporate Taisei Nagasio Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035740
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
