UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050089 |
|---|---|
| Receipt number | R000057060 |
| Scientific Title | A multicentre prospective cohort study on the effect of exercise and physical activity on functional decline, cardiovascular disease and mortality in patients undergoing hemodialysis |
| Date of disclosure of the study information | 2023/01/21 |
| Last modified on | 2025/01/20 19:12:26 |
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Basic information
Public title
A multicentre prospective cohort study on the effect of exercise and physical activity on functional decline, cardiovascular disease and mortality in patients undergoing hemodialysis
Acronym
REPnet Cohort
Scientific Title
A multicentre prospective cohort study on the effect of exercise and physical activity on functional decline, cardiovascular disease and mortality in patients undergoing hemodialysis
Scientific Title:Acronym
REPnet Cohort
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of the effect of reduction for functional decline, cardiovascular disease, and mortality by exercise and physical activity management
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Incidence of functional decline (physical function, nutritional status, cognitive function) at 1, 2, 3, 4, and 5 years after cohort entry
2. Effect of reduction for cardiovascular disease by exercise and physical activity
3. Effect of reduction for mortality by exercise and physical activity
Key secondary outcomes
cachexia
Fall
dialysis hypotension
frailty
sarcopenia
osteoporosis
Base
Study type
Observational
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. age: 20 years or more
2. dialysis vintage: 3 months or more
Key exclusion criteria
1. Patients who can not be allowed to join this study
2. dialysis vintage: 3 months or less
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Masakazu |
| Middle name | |
| Last name | Saitoh |
Organization
Juntendo University
Division name
Department of Physical Therapy, Faculty of Health Science
Zip code
113-0033
Address
3-12-22, Hongo, Bukyo-ku, Japan
TEL
03-3811-3111
m.saito.tl@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Masakazu |
| Middle name | |
| Last name | Saitoh |
Organization
Juntendo University
Division name
Department of Physical Therapy, Faculty of Health Science
Zip code
113-0033
Address
3-12-22, Hongo, Bukyo-ku, Japan
TEL
03-3813-3111
Homepage URL
m.saito.tl@juntendo.ac.jp
Sponsor or person
Institute
other
Institute
Department
Personal name
Masakazu Saitoh
Funding Source
Organization
Japan Society for the Promotion of Science KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of department of Physical Therapy, Faculty of Health Science Juntendo University
Address
3-2-12, Hongo, Bunkyo-ku, Japan
Tel
03-3813-3111
r.hayashi.yt@juntendo.ac.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
順天堂大学(東京）、嬉泉病院（東京）、聖路加国際病院（東京）、三井記念病院（東京）、東葛クリニック（千葉）、岩槻南病院（埼玉）、新潟臨港病院（新潟）、魚沼基幹病院（新潟）、上尾中央総合病院（埼玉）、石和共立病院（山梨）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 21 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Among haemodialysis patients.
1) Less likely to experience functional decline if exercise therapy and appropriate physical activity management are in place
2) A reduction in cardiovascular morbidity and mortality is more likely to be observed.
Exercise and appropriate physical activity management are beneficial for healthy life expectancy in haemodialysis patients.
Management information
Registered date
| 2023 | Year | 01 | Month | 20 | Day |
Last modified on
| 2025 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057060
