UMIN-CTR Clinical Trial

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
Email	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
Email	nfujii-npr@umin.net

Sponsor
Institute	Hyogo Prefectural Nishinomiya Hospital / Japanese Society of Nephrology
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056154