UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049451 |
|---|---|
| Receipt number | R000056154 |
| Scientific Title | The Clinical Effects of Exercise in Non-obese Patients with Chronic Kidney Disease: A Systematic Review and Meta-analysis |
| Date of disclosure of the study information | 2022/11/07 |
| Last modified on | 2022/11/07 20:38:05 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The Clinical Effects of Exercise in Non-obese Patients with Chronic Kidney Disease: A Systematic Review and Meta-analysis
Acronym
A Systematic Review of Exercise in Patients with CKD.
Scientific Title
The Clinical Effects of Exercise in Non-obese Patients with Chronic Kidney Disease: A Systematic Review and Meta-analysis
Scientific Title:Acronym
A Systematic Review of Exercise in Non-obese Patients with CKD,
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To conduct a systematic review to clarify the clinical effects of exercise in non-obese patients with chronic kidney disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Kidney function (eGFR)
2) QOL (SF36)
3) Proteinuria (uPCR)
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
All randomized controlled trials and prospective intervention studies examining the clinical effects of exercise in patients with chronic kidney disease.
Key exclusion criteria
Observational studies, case reports, animal studies, and intervention studies involving only obese patients were excluded.
Target sample size
0
Research contact person
Name of lead principal investigator
| 1st name | Naohiko |
| Middle name | |
| Last name | Fujii |
Organization
Hyogo Prefectural Nishinomiya Hospital
Division name
Department of Nephrology
Zip code
662-0918
Address
13-9 Rokutanji-cho, Nishinomiya, Hyogo
TEL
+81-798-34-5151
nfujii-npr@umin.net
Public contact
Name of contact person
| 1st name | Naohiko |
| Middle name | |
| Last name | Fujii |
Organization
Hyogo Prefectural Nishinomiya Hospital
Division name
Department of Nephrology
Zip code
662-0918
Address
13-9 Rokutanji-cho, Nishinomiya, Hyogo
TEL
+81-798-34-5151
Homepage URL
nfujii-npr@umin.net
Sponsor or person
Institute
Hyogo Prefectural Nishinomiya Hospital / Japanese Society of Nephrology
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Nephrology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kansai Rosai Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo Prefectural Nishinomiya Hospital
Address
13-9 Rokutanji-cho, Nishinomiya, Hyogo
Tel
+81-798-34-5151
kennishi-chiken@hp.pref.hyogo.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
| 2022 | Year | 11 | Month | 07 | 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
0
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
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
The guidelines of the Japanese Society of Renal Rehabilitation concluded that exercise intervention for patients with non-dialysis-dependent CKD has the potential to improve physical function and QOL and to maintain kidney function; however, most of the cited articles were written for obese patients, which does not necessarily match the CKD patients we see in our daily clinical practice. Therefore, we will conduct a systematic review based on the latest RCTs published in PubMed from 1990 to the end of 2021 in patients with non-dialysis-dependent CKD without obesity. Outcomes will be determined using the Delphi method, and the risk of bias will be assessed by multiple reviewers. Meta-analysis will be performed if necessary.
Management information
Registered date
| 2022 | Year | 11 | Month | 07 | Day |
Last modified on
| 2022 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056154
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
