UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Difference in lower leg muscle strength between hemodialysis patients and preservative CKD patients
Title of the study (Brief title)	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	Nobuyuki Shirai
Organization	Niigata Rinko Hospital, Niigata, Japan
Division name	Department of Rehabilitation
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	Nobuyuki Shirai
Organization	Niigata Rinko Hospital, Niigata, Japan
Division name	Department of Rehabilitation
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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