UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043195 |
|---|---|
| Receipt number | R000049295 |
| Scientific Title | Effects of Renal Rehabilitation on Frailty in Dialysis Patients |
| Date of disclosure of the study information | 2021/01/31 |
| Last modified on | 2024/02/03 18:20:04 |
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Basic information
Public title
Effects of Renal Rehabilitation on Frailty in Dialysis Patients
Acronym
Effects of Renal Rehabilitation on Frailty in Dialysis Patients
Scientific Title
Effects of Renal Rehabilitation on Frailty in Dialysis Patients
Scientific Title:Acronym
Effects of Renal Rehabilitation on Frailty in Dialysis Patients
Region
| Japan |
Condition
Condition
End-stage Kidney Disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is verified whether that the kidney rehabilitation is tackled by the cooperation of multioccupation prevents the frailty of the dialysis case, that it reduces the tipping over fall, that the activity of daily living is kept, and that it shortens the hospitalization.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
falling accident rate, and length of hospital stay
Key secondary outcomes
To determine the difference in sarcopenia indices in inpatients undergoing hemodialysis before and after a
multidisciplinary renal rehabilitation program, exploring independently relevant factors affecting the number of falls and length of hospitalization.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Patients hospitalized in our hospital undergoing hemodialysis should be screened, and renal rehabilitation should be performed in cooperation with various occupations for patients with suspected progression of frailty.
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
| 18 | years-old | <= |
Age-upper limit
| 110 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The subjects were hemodialysis patients who required hospitalization in our hospital for more than 2 weeks (be expected to).
Key exclusion criteria
1) Offer of non-participation
2) Discontinuation of dialysis or discharge within 2 weeks
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Tokumoto |
Organization
Japanese Red Cross Fukuoka hospital
Division name
Division of Nephrology and Dialysis Center
Zip code
815-8555
Address
3-1-1 Ogusu, Minami-ku, Fukuoka, 815-8555, Japan
TEL
+81-92-521-1211
koji@fukuoka-med.jrc.or.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Nakai |
Organization
Japanese Red Cross Fukuoka hospital
Division name
Division of Nephrology and Dialysis Center
Zip code
815-8555
Address
3-1-1 Ogusu, Minami-ku, Fukuoka, 815-8555, Japan
TEL
+81-92-521-1211
Homepage URL
k-nakai@fukuoka-med.jrc.or.jp
Sponsor or person
Institute
Japanese Red Cross Fukuoka hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese Red Cross Fukuoka hospital
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
Japanese Red Cross Fukuoka hospital
Address
3-1-1 Ogusu, Minami-ku, Fukuoka, 815-8555, Japan
Tel
+81-92-521-1211
soumu@fukuoka-med.jrc.or.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 01 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | 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
Management information
Registered date
| 2021 | Year | 01 | Month | 31 | Day |
Last modified on
| 2024 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049295
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
