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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035838
Receipt No. 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

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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
Email 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
Email shiraino9@gmail.com

Sponsor
Institute Niigata Rinko Hospital, Niigata, Japan
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039645

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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