UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038246 |
|---|---|
| Receipt number | 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 | 2022/08/26 07:56:50 |
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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
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
kinen.eiyo@shinkohkai.jp
Sponsor or person
Institute
Shinkohkai murakamikinen hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043597
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