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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039104
Receipt No. R000044597
Scientific Title Exploratory study of rehabilitation during hemodialysis and nutrition therapy for hemodialysis patients with sarcopenia
Date of disclosure of the study information 2020/01/10
Last modified on 2020/01/09

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Basic information
Public title Exploratory study of rehabilitation during hemodialysis and nutrition therapy for hemodialysis patients with sarcopenia
Acronym Exploratory study of rehabilitation during hemodialysis and nutrition therapy for hemodialysis patients with sarcopenia
Scientific Title Exploratory study of rehabilitation during hemodialysis and nutrition therapy for hemodialysis patients with sarcopenia
Scientific Title:Acronym Exploratory study of rehabilitation during hemodialysis and nutrition therapy for hemodialysis patients with sarcopenia
Region
Japan

Condition
Condition End-stage Kidney Disease (on Hemodialysis)
Classification by specialty
Nephrology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To date, the applicant has studied the effects of combined rehabilitation and nutritional therapy during hemodialysis on hemodialysis patients with sarcopenia in a single institutional cohort, and reported that sarcopenia improves three months later. The purpose of this study is to expand the feasibility and generalization of single-center intervention studies to multiple centers.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sarcopenia improvement in study subjects after 6 months
Key secondary outcomes Changes in various blood data, body components (lower limb muscle mass, upper limb muscle mass, skeletal muscle index), MIS (Malnutrition Inflammation Score), GNRI (Geriatric Nutritional Risk Index), QIDS-J (Quick Inventry of Depressive Symptomatology)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food Device,equipment
Interventions/Control_1 An interventional study with general rehabilitation performed during dialysis and already commercially available amino jelly leucine 40 (per 100 g: energy 30 kcal, protein 3.0 g, lipid 0 g, carbohydrate 9.7 g, water 87 g)
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
18 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Patients who have undergone maintenance hemodialysis at Sapporo Medical University Hospital, Obihiro Kosei Hospital, Teine Keijinkai Hospital, or JR Sapporo Hospital, and who obtained consent from patients diagnosed with sarcopenia
Key exclusion criteria Excludes limb deficiency, history of orthopedic surgery within 3 months, age under 18, age 90 and older, history of malignant disease, history of spinocerebellar degeneration, and pregnant women
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Masayuki
Middle name
Last name Koyama
Organization Sapporo Medical University, School of Medicine
Division name Department of Public Health and Department of Cardiovascular, Renal and Metabolic Medicine
Zip code 060-8543
Address South-1, West-17, Chuo-ku, Sapporo
TEL +81-11-611-2111(27420)
Email masa3yuki3@sapmed.ac.jp

Public contact
Name of contact person
1st name Masayuki
Middle name
Last name Koyama
Organization Sapporo Medical University, School of Medicine
Division name Department of Public Health and Department of Cardiovascular, Renal and Metabolic Medicine
Zip code 060-8543
Address South-1, West-17, Chuo-ku, Sapporo
TEL +81-11-611-2111(27420)
Homepage URL
Email masa3yuki3@sapmed.ac.jp

Sponsor
Institute Sapporo Medical University, School of Medicine
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science(JSPS)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Sapporo Medical University Hospital IRB
Address South-1, West-16, Chuo-ku, Sapporo
Tel +81-11-611-2111 ext. 31470
Email ji-rskk@sapmed.ac.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
2020 Year 01 Month 10 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 Preinitiation
Date of protocol fixation
2019 Year 10 Month 10 Day
Date of IRB
Anticipated trial start date
2020 Year 02 Month 01 Day
Last follow-up date
2021 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2022 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2020 Year 01 Month 09 Day
Last modified on
2020 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044597

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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