UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059170 |
|---|---|
| Receipt number | R000067672 |
| Scientific Title | Registry of the renal rehabilitation in patients with chronic kidney disease |
| Date of disclosure of the study information | 2025/09/25 |
| Last modified on | 2025/09/23 20:14:42 |
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Basic information
Public title
Registry of the renal rehabilitation in patients with chronic kidney disease
Acronym
REVEAL study
Scientific Title
Registry of the renal rehabilitation in patients with chronic kidney disease
Scientific Title:Acronym
REVEAL study
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
With the progression of chronic kidney disease and the aging of the population, the number of chronic kidney disease patients with frailty and sarcopenia is increasing year by year, and the importance of renal rehabilitation is recognized. In 2022, the Japanese government started a new insurance coverage for exercise therapy for dialysis patients. However, its effectiveness and safety have not been sufficiently investigated. Therefore, we aimed to create a registry of renal rehabilitation for chronic kidney disease patients and to evaluate its effectiveness and safety from multiple perspectives.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
mortality, cardiovascular events, and bone fractures
Key secondary outcomes
Changes in physical ability, physical activity, activities of daily living, nutritional indicators, cognitive function, quality of life, and biomarkers etc.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Chronic kidney disease patients who already started or will be started renal rehabilitation
Key exclusion criteria
Patients who are bedridden, have limb defects, have advanced dementia, or are otherwise deemed inappropriate by their attending physician
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Hoshino |
Organization
Tokyo Women's Medical University
Division name
Department of Nephrology
Zip code
162-8666
Address
8-1, Kawada-cho, Shinjuku, Tokyo
TEL
03-3353-8112
hoshino.junichi@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Shizuka |
| Middle name | |
| Last name | Kobayashi |
Organization
Tokyo Women's Medical University
Division name
Department of Nephrology
Zip code
162-8666
Address
8-1, Kawada-cho, Shinjuku, Tokyo
TEL
03-3353-8112
Homepage URL
kobayashi.shizuka@twmu.ac.jp
Sponsor or person
Institute
The Japanese Society of Renal Rehabilitation
Institute
Department
Personal name
Funding Source
Organization
The Japanese Society of Renal Rehabilitation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of the Tokyo Women's Medical University
Address
8-1, Kawada-cho, Shinjuku, Tokyo
Tel
03-3353-8112
rinri.bm@twmu.ac.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
| 2025 | Year | 09 | Month | 25 | 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
| 2025 | Year | 08 | Month | 13 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 21 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In conjunction with this study, a retrospective study (January 2021 to January 2024) on the effectiveness and safety of exercise therapy for patients with dialysis is currently being conducted with approval from the Tokyo Women's Medical University Ethics Committee on February 17, 2025 (Approved No. 2023-0204).
Management information
Registered date
| 2025 | Year | 09 | Month | 23 | Day |
Last modified on
| 2025 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067672
