UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039745 |
|---|---|
| Receipt number | 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 | 2020/11/29 14:33:43 |
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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
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
keipons55@yahoo.co.jp
Sponsor or person
Institute
Matsumoto City Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045323
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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