UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037682 |
|---|---|
| Receipt number | R000042792 |
| Scientific Title | Effects of renal rehabilitation on motor function in home facilities for patients with pre-dialysis CKD and home hemodialysis |
| Date of disclosure of the study information | 2019/09/01 |
| Last modified on | 2019/08/20 13:17:11 |
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Basic information
Public title
Effects of renal rehabilitation on motor function in home facilities for patients with pre-dialysis CKD and home hemodialysis
Acronym
Effects of renal rehabilitation on motor function in home facilities for patients with pre-dialysis CKD and home hemodialysis
Scientific Title
Effects of renal rehabilitation on motor function in home facilities for patients with pre-dialysis CKD and home hemodialysis
Scientific Title:Acronym
Effects of renal rehabilitation on motor function in home facilities for patients with pre-dialysis CKD and home hemodialysis
Region
| Japan |
Condition
Condition
choronic renal disease
Classification by specialty
| Nephrology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study was to examine the improvement effect of exercise function by renal rehabilitation in patients with with pre-dialysis chronic kidney disease and in home hemodialysis patients at home facilities.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Exercise functions are evaluated by 6 minutes walking, Time "Up and Go" test, normal walking speed, maximum walking speed, 30 seconds sitting, 5 times sitting before and 1, 3, 6 months after renal rehabilitation.
Key secondary outcomes
Muscle mass (grip strength, large chest muscle strength, quadriceps femoris muscle strength), physical findings (body weight, cardiothoracic ratio), ADL (Functional Independence Measure) and blood data (blood hemoglobin concentration, serum albumin concentration, Kt / V, nPCR Evaluate) are evaluated before and 1, 3, 6 months after renal rehabilitation. At the same time, renal functions (blood urea nitrogen, creatinine, glomerular filtration rate, urinary protein) are evaluated in pre-dialysis chronic kidney disease patients.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Among the residents in Medical Home Fujimino, we will carry out kidney rehabilitation for patients with chronic kidney disease patients not on dialysis (5 patients) and home hemodialysis patients (10 patients) who agreed to perform renal rehabilitation.
Key exclusion criteria
Hemodialysis patients are excluded from this study when they discontinue dialysis, transition to peritoneal dialysis, combined with peritoneal dialysis, or receive kidney transplantation.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Tsuji |
Organization
Fuke Home Medical Rehabilitation Care Center
Division name
Medical division
Zip code
356-0051
Address
1839-4 Kamekubo, Fujimino Saitama, Japan
TEL
049-293-8222
atsuji@fukekai.com
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Tsuji |
Organization
Fuke Rehabilitation Home Care Center
Division name
Medical division
Zip code
356-0051
Address
1839-4 Kamekubo, Fujimino Saitama, Japan
TEL
049-293-8222
Homepage URL
http://www.fuke-zaitaku.com/
atsuji@fukekai.com
Sponsor or person
Institute
Fuke Rehabilitation Home Care Center
Medical division
Institute
Department
Personal name
Funding Source
Organization
Fuke hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Fuke hospital
Address
2197 Kamekubo, Fujimino Saitama, Japan
Tel
049-264-8811
t-futaesaku@fukekai.com
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
富家在宅リハビリテーションケアセンター / Fuke Home Medical Rehabilitation Care Center
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 14 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2021 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2021 | Year | 08 | Month | 31 | Day |
Other
Other related information
This is the observational study of cases. The subjects are 10 pre-dialysis CKD patients and 10 home hemodialysis patients who lived in Medical Home Fujimino from September 2019 to March 2020. The exercise programs consist of (1) Stretching the extremities trunk (2) Aerobic exercise (walking or ergometer, Borg scale 11 to 13 intensity for 20-60 minutes) A physical therapist drafts an individual program (set / day) and implements it three days a week (partly supervised twice, once self-managed). The items to be measured are 6 minutes walking for motor function, Time "Up and Go" test, normal walking speed, maximum walking speed, 30 seconds standing and sitting 5 times before study and after 1, 3 and 6 months.
Management information
Registered date
| 2019 | Year | 08 | Month | 14 | Day |
Last modified on
| 2019 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042792
