UMIN-CTR Clinical Trial

Basic information
Public title	The effectiveness of physical exercise training in patients with non-dialysis chronic kidney disease: a systematic review and meta-analysis of randomized controlled trials
Acronym	The effectiveness of physical exercise training in patients with non-dialysis chronic kidney disease: a systematic review and meta-analysis of randomized controlled trials
Scientific Title	The effectiveness of physical exercise training in patients with non-dialysis chronic kidney disease: a systematic review and meta-analysis of randomized controlled trials
Scientific Title:Acronym	The effectiveness of physical exercise training in patients with non-dialysis chronic kidney disease: a systematic review and meta-analysis of randomized controlled trials
Region	Japan

Condition
Condition	adult participants (18 years or older) with stage 2-5 chronic kidney disease with non dialysis.
Classification by specialty	Endocrinology and Metabolism Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine effectiveness of physical exercise training on physical function, kidney function and all-cause mortality in patients with non-dialysis chronic kidney disease
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1) All cause mortality 2) Kidney function (eGFR, serum creatinine, proteinuria) 3) Physical capacity (peak/maximum oxygen uptake)
Key secondary outcomes	1) Adverse events 2) Physical function (muscle strength, time up go test, 6-min walking test) 3) Health-related quality of life

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	We will include adult participants (18 years or older) with stage 2-5 chronic kidney disease with non dialysis.
Key exclusion criteria	We will exclude participants who have undergone a renal replacement therapy such as dialysis or a kidney transplant.
Target sample size

Research contact person
Name of lead principal investigator	1st name Nakamura Middle name Last name Keisuke
Organization	Matsumoto City Hospital
Division name	Rehabilitation
Zip code	390-1401
Address	4417-180, Hata, Matsumoto, Nagano
TEL	0263-92-3027
Email	keipons55@yahoo.co.jp

Public contact
Name of contact person	1st name Nakamura Middle name Last name Keisuke
Organization	Matsumoto City Hospital
Division name	Rehabilitation
Zip code	390-1401
Address	4417-180, Hata, Matsumoto
TEL	0263-92-3027
Homepage URL
Email	keipons55@yahoo.co.jp

Sponsor
Institute	Matsumoto City Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Matsumoto City Hospital
Address	4417-180, Hata, Matsumoto
Tel	0263-92-3027
Email	keipons55@yahoo.co.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 03 Month 12 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://www.nature.com/articles/s41598-020-75405-x
Number of participants that the trial has enrolled	848
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	2019 Year 08 Month 01 Day
Date of IRB	2019 Year 03 Month 12 Day
Anticipated trial start date	2019 Year 08 Month 01 Day
Last follow-up date	2021 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2020 Year 04 Month 20 Day

Other

Other related information

Two review authors will screen search results (title and abstract) of all potentially relevant studies as a result of the search. We will assess the full-text study reports/publications and two review authors will independently screen the full-text and identify studies for inclusion. We will resolve any disagreement in discussion or we will consult other review authors. We will use a data collection form for study characteristics and outcome data, which has been piloted on at least one study in the review. Two review authors (KN and TS) will extract characteristics from included studies, as follows: Methods: study design, total duration of study, location, study setting, withdrawals, and date of study. Participants: N, mean age, age range, gender, severity of condition, diagnostic criteria, cause of kidney disease, inclusion criteria, and exclusion criteria. Interventions: intervention, comparison. Outcomes: primary and secondary outcomes specified and collected, and time points reported.

Management information
Registered date	2020 Year 03 Month 09 Day
Last modified on	2020 Year 11 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045323