UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035838 |
|---|---|
| Receipt number | R000039645 |
| Scientific Title | Difference in lower leg muscle strength between hemodialysis patients and preservative CKD patients |
| Date of disclosure of the study information | 2019/02/12 |
| Last modified on | 2019/02/11 22:51:20 |
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Basic information
Public title
Difference in lower leg muscle strength between hemodialysis patients and preservative CKD patients
Acronym
Leg muscle strength of CKD patients
Scientific Title
Difference in lower leg muscle strength between hemodialysis patients and preservative CKD patients
Scientific Title:Acronym
Leg muscle strength of CKD patients
Region
| Japan |
Condition
Condition
CKD patients
Classification by specialty
| Nephrology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
o verify the lower leg muscular strength of preservation CKD patients and HD patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Isometric knee extension muscular strength
At the initial evaluation
Key secondary outcomes
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
| 40 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
CKD patients of CKD stage 3a - 5D visiting outpatient
Key exclusion criteria
Those who are difficult to walk due to motor diseases or central diseases, those with severe respiratory and cardiovascular diseases, those with a decline in cognitive function, Person who HD is less than 1 year , CKD Stage 1 - 2 ,Those who lacked the measurement items, if the subject person can not agree to participate, it was excluded from the subject.
Target sample size
128
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Shirai |
Organization
Niigata Rinko Hospital, Niigata, Japan
Division name
Department of Rehabilitation
Zip code
Address
Momoyama-cho 1-114-3, Higashi-ku, Niigata City 950-8725, Japan
TEL
025-274-5331
shiraino9@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Shirai |
Organization
Niigata Rinko Hospital, Niigata, Japan
Division name
Department of Rehabilitation
Zip code
Address
Momoyama-cho 1-114-3, Higashi-ku, Niigata City 950-8725, Japan
TEL
025-274-5331
Homepage URL
shiraino9@gmail.com
Sponsor or person
Institute
Niigata Rinko Hospital, Niigata, Japan
Institute
Department
Personal name
Funding Source
Organization
No
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
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
000039645
Org. issuing International ID_1
Niigata Rinko Hospital, Niigata, Japan
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 12 | 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
| 2016 | Year | 06 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
It is suggested that HD patients may be associated with decreased lower limb muscular strength and grip strength compared to pre-dialysis CKD patient.
Management information
Registered date
| 2019 | Year | 02 | Month | 11 | Day |
Last modified on
| 2019 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039645
