UMIN-CTR Clinical Trial

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	unpublished
Publication of results	Unpublished

Result
URL related to results and publications	unpublished
Number of participants that the trial has enrolled	76
Results	We found significant effect for MH in LT+ONS group compared to LT group, but other QOL components were not significant different between LT group and LT+ONS group. In LT+ONS group, stand-up test and 2-step value were significant improvement after intervention.
Results date posted	2022 Year 08 Month 26 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	All subjects participated previous study was 76, then, we excluded 5 subjects without LS. Seventy-one subjects were explained to object and protocol of study, and 31 subjects refused participation to this study. Therefore, we enrolled 40 subjects to this study.
Participant flow	There were 2 losses throughout the study: In LT+ONS group, one patient is hospitalization, and one patient could not evaluate outcome at end of study due to not well condition.
Adverse events	In LT+ONS group, one subject occured soft stool
Outcome measures	QOL(physical functioning, role physical, bodily pain, social functioning, general health perceptions, vitality, role emotional, mental health), and three component scores (physical component summary, mental component summary, and role-social component summary) Locomo test(stand-up test, 2-step test, locomo 25), BMI, SMI, body fat, ECW/TCW, serum albumin, CRP, BUN, Cr, K, P, Hb, MNA-SF, GNRI
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	2022 Year 08 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043597