UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039104 |
|---|---|
| Receipt number | 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 | 2023/01/11 11:41:22 |
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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)
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
masa3yuki3@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University, School of Medicine
Institute
Department
Personal name
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
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
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044597
Publication of results
Unpublished
Result
URL related to results and publications
https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-19K19872/
Number of participants that the trial has enrolled
3
Results
At baseline, 4 of 16 hemodialysis patients (age 71.5 [Q1 64.8, Q3 78.0] years, 50% female) had sarcopenia based on AWGS criteria.
Consent was obtained for 3 of the 16 patients, and the "dialysis rehabilitation (nutritional therapy + exercise therapy)" indicated in this study was implemented. No improvement in sarcopenia, the primary endpoint, was obtained, but this was thought to be largely a matter of sample size.
Results date posted
| 2023 | Year | 01 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Prevalence of hemodialysis patients with sarcopenia
At baseline, 4 of 16 hemodialysis patients (age 71.5 years [Q1 64.8, Q3 78.0], 50% female) had sarcopenia based on AWGS criteria.
Participant flow
In the latter half of the first year of the study, the impact of the novel coronavirus infection (COVID-19) pandemic made it difficult to conduct the study. The situation of the outbreak of clusters at each dialysis facility made it extremely difficult to conduct rehabilitation, which is the core of this study, and it became impossible to accumulate the number of cases that had been planned for the study. Although only one facility was able to conduct infection control precisely and obtain the consent of the ethics committee, and only a few of those cases were able to obtain individual consent, we analyzed as many cases as possible.
Adverse events
none
Outcome measures
*Primary endpoints
Consent was obtained for 3 of 16 patients, and the "dialysis rehabilitation (nutritional therapy + exercise therapy)" indicated in this study was implemented. No improvement in sarcopenia, the primary endpoint, was obtained, but we believe this was largely due to the sample size.
*Secondary endpoints
Secondary endpoints were as follows: changes in various blood data (including high-sensitivity C-reactive protein, abnormal glucose and lipid metabolism), lower limb muscle mass, upper limb muscle mass, skeletal muscle index (limb muscle mass (kg)/height (m) squared), upper arm circumference and subcutaneous fat thickness, upper arm muscle area, MIS (Malnutrition Inflammation Score), GNRI (Geriatric Nutritional Risk Index), and QIDS-J (Quick Inventry of Depressive Symptomatology).
Although it is difficult to evaluate changes over time in the secondary endpoints described in the previous section due to the small sample size, at least no significant increase or decrease was indicated.
*Other considerations
The remaining 13 patients continued only 3 months of exercise therapy, which resulted in a significant improvement in gait speed, independent of the presence or absence of sarcopenia.
This subanalysis was published by the collaborators and is a valuable report of the effect of short-term exercise therapy in the dialysis unit under COVID-19 (Koki Abe, et al. Ren Replace Ther. 2020; 6(1): 36).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 10 | Day |
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
| 2023 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044597
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