UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038246
Receipt No. R000043597
Scientific Title Association between locomotive syndrome and quality of life in hemodialysis patients.
Date of disclosure of the study information 2019/10/10
Last modified on 2019/10/11

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Association between locomotive syndrome and quality of life in hemodialysis patients.
Acronym Association between locomotive syndrome and quality of life in hemodialysis patients.
Scientific Title Association between locomotive syndrome and quality of life in hemodialysis patients.
Scientific Title:Acronym Association between locomotive syndrome and quality of life in hemodialysis patients.
Region
Japan

Condition
Condition Hemodialysis
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 we purpose as follows: (1) To clarify prevalence of Locomo in hemodialysis patients; (2) To assess associated factor of Locomo, in particular, association of QOL and Locomo.
Basic objectives2 Others
Basic objectives -Others we purpose as follows: (1) To clarify prevalence of Locomo in hemodialysis patients; (2) To assess associated factor of Locomo, in particular, association of QOL and Locomo.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Association between locomo severity and QOL
Key secondary outcomes Body composition(Body mass index, Skeletel muscle index, body fat, ECW/TBW, phase angle), Laboratory values(Alb, CRP, BUN, Cr, Ca, IP, Hb), Nutritional parameter(GNRI, MNA-SF)

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Subjects underwent regular hemodialysis therapy 3 times per week for more than 1 year.
Key exclusion criteria Acute myocardial infraction developed within 2 days, unstable angina not controlled with medical treatment, uncontrolled arrthythmia that cause symptoms or hemodynamic compromise, symptomatic severe arotic stenosis, uncontrolled symptomatic heart failure, acute pulmonary embolism or pulmonary infarction, acute myocarditis or pericarditis, acute arotic dissection, mental disorders associated with communication difficulties, left main coronary artery stenosis, moderate stenotic valvular heart disease, electrolyte abnormality, severe hypertension (systolic blood pressure of >200 mmHg and/or diastolic blood pressure of >110 mmHg), tachyarrhythmia or bradyarrhythmia, hypertrophic cardiomyopathy or other outflow tract obstruction, mental or physical impairment leading to inability to exercise adequately, advanced atrioventricular
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Kitabayashi
Middle name
Last name Kou
Organization Shinkohkai Murakamikinen Hospital
Division name Department of nutrition
Zip code 958-0034
Address 204-1, matuyama, murakami-si, Niigata, Japan
TEL 0254-52-1229
Email kinen.eiyo@shinkohkai.jp

Public contact
Name of contact person
1st name Kitabayashi
Middle name
Last name Kou
Organization Shinkohkai Murakamikinen Hospital
Division name Department of nutrition
Zip code 958-0034
Address 204-1, matuyama, murakami-si, Niigata, Japan
TEL 0254-52-1229
Homepage URL
Email kinen.eiyo@shinkohkai.jp

Sponsor
Institute Shinkohkai murakamikinen hospital
Institute
Department

Funding Source
Organization The Kidney Foundation, Japan
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor Santo-second Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization Shinkohkai murakamikinen hospital ethics committee
Address 958-0034
Tel 0254-52-1229
Email kinen.me@shinkohkai.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
2019 Year 10 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 76
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
2017 Year 06 Month 30 Day
Date of IRB
2017 Year 10 Month 02 Day
Anticipated trial start date
2018 Year 09 Month 01 Day
Last follow-up date
2018 Year 10 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Cross-sectional study

Management information
Registered date
2019 Year 10 Month 09 Day
Last modified on
2019 Year 10 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043597

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.