UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049477 |
|---|---|
| Receipt number | R000056335 |
| Scientific Title | Association between hospitalisation rates and life expectancy in haemodialysis patients. |
| Date of disclosure of the study information | 2022/11/11 |
| Last modified on | 2022/11/10 20:33:31 |
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Basic information
Public title
Association between hospitalisation rates and life expectancy of dialysis patients in physical activity.
Acronym
Association between hospitalisation rates and life expectancy in haemodialysis patients.
Scientific Title
Association between hospitalisation rates and life expectancy in haemodialysis patients.
Scientific Title:Acronym
AHRLE
Region
| Japan |
Condition
Condition
Dialysis patient
Classification by specialty
| Medicine in general | Nephrology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Association between hospitalisation rates and life expectancy in haemodialysis patients.
Basic objectives2
Others
Basic objectives -Others
Discriminating between sarcopenia and frailty predictions.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Life expectancy and readmission rates
Key secondary outcomes
Association of activity with quality of life and physical function
Discrimination of sarcopenia and frailty prediction.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
low-activity
Interventions/Control_2
high activity
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
dialysis patient
Key exclusion criteria
Severe dementia
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yoshitatsu |
| Middle name | |
| Last name | Fukuta |
Organization
Asahi University Hospital
Division name
Department of rehabilitation
Zip code
500-8523
Address
3-23, Hashimoto-cho, Gifu, Gifu
TEL
058-253-8001
yoshitatsu.f@gmail.com
Public contact
Name of contact person
| 1st name | Yoshitatsu |
| Middle name | |
| Last name | Fukuta |
Organization
Asahi University Hospital
Division name
Department of rehabilitation
Zip code
500-8523
Address
3-23, Hashimoto-cho, Gifu, Gifu
TEL
058-253-8001
Homepage URL
yoshitatsu.f@gmail.com
Sponsor or person
Institute
Asahi University Hospital
Institute
Department
Personal name
Funding Source
Organization
Asahi University 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
Asahi University Hospital
Address
3-23, Hashimoto-cho, Gifu, Gifu
Tel
058-253-8001
yoshitatsu.f@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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 11 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2027 | Year | 11 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 10 | Day |
Last modified on
| 2022 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056335
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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