UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050819 |
|---|---|
| Receipt number | R000057916 |
| Scientific Title | Investigation of the actual condition of sarcopenia in chronic maintenance hemodialysis patients and the effect of renal rehabilitation |
| Date of disclosure of the study information | 2023/04/29 |
| Last modified on | 2023/04/11 21:42:04 |
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Basic information
Public title
Investigation of the actual condition of sarcopenia in chronic maintenance hemodialysis patients and the effect of renal rehabilitation
Acronym
Sarcopenia and Exercise Therapy in Dialysis Patients
Scientific Title
Investigation of the actual condition of sarcopenia in chronic maintenance hemodialysis patients and the effect of renal rehabilitation
Scientific Title:Acronym
Sarcopenia and Exercise Therapy in Dialysis Patients
Region
| Japan |
Condition
Condition
chronic kidney failure
Classification by specialty
| Nephrology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the prevalence of sarcopenia, frailty, and locomotive syndrome in patients with chronic renal failure and to determine the usefulness of rehabilitation.
Basic objectives2
Others
Basic objectives -Others
Investigating the Association of Adverse Events with Sarcopenia, Frailty, and Locomotive Syndrome in Patients with Chronic Renal Failure.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Muscle mass, frailty, sarcopenia, locomotive syndrome
Key secondary outcomes
biochemical test data (AST, ALT, LD, ALP, , cholinesterase, CRP, total protein, albumin, BUN, Na, K, Cl, total cholesterol, triglycerides, CK, HbA1c, PT%, PT-INR, red cell count, hemoglobin concentration, white cell count, lymphocyte%, platelet count), physical function assessment (grip strength, limb circumference, balance test, gait speed, exercise stress test, activities of daily living assessment), questionnaires (Life Space Assessment, Locomo 25)
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Age of 20 years or older
Patients who have been prescribed a rehabilitation prescription and have completed it.
Key exclusion criteria
Patients who are deemed inappropriate as research subjects by the principal investigator and assistants.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Hirota |
Organization
Kurume University Hospital
Division name
Kurume University Hospital
Zip code
830-0011
Address
67 Asahi-cho, Kurume-shi, Fukuoka
TEL
0942317645
hirota_kerisuke@kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Hirota |
Organization
Kurume University Hospital
Division name
Kurume University Hospital
Zip code
830-0011
Address
67 Asahi-cho, Kurume-shi, Fukuoka
TEL
0942317645
Homepage URL
hirota_kerisuke@kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
Hirota Keisuke
Funding Source
Organization
Kurume University
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
Kurume University Hospital
Address
67 Asahimachi, Kurume City, Fukuoka
Tel
0942317645
hirota_keisuke@kurume-u.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
| 2023 | Year | 04 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2027 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing in particular
Management information
Registered date
| 2023 | Year | 04 | Month | 11 | Day |
Last modified on
| 2023 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057916
