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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039745
Receipt No. R000045323
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
Date of disclosure of the study information 2020/03/12
Last modified on 2020/03/09

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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 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 Preinitiation
Date of protocol fixation
2019 Year 08 Month 01 Day
Date of IRB
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

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 03 Month 09 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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