UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015276 |
|---|---|
| Receipt number | R000017768 |
| Scientific Title | Effects of exercise training on kidney function in patients with chronic kidney disease: A prospective multicenter study |
| Date of disclosure of the study information | 2014/10/01 |
| Last modified on | 2018/10/02 12:28:20 |
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Basic information
Public title
Effects of exercise training on kidney function in patients with chronic kidney disease: A prospective multicenter study
Acronym
CKD-Ex Study
Scientific Title
Effects of exercise training on kidney function in patients with chronic kidney disease: A prospective multicenter study
Scientific Title:Acronym
CKD-Ex Study
Region
| Japan |
Condition
Condition
CKD patients
Classification by specialty
| Cardiology | Nephrology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effects of exercise training on kidney function in patients with CKD
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Etimated glomerular filtration rate (eGFR)
Key secondary outcomes
Urine protein, urinary albumin
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Intervention group
Frequency: Aerobic exercise training more than 3/week (include supervised aerobic exercise training more than 2/week)
Time: 30-60min/day
Intensity: aerobic threshold (AT) level calculated by cardiopulmonary exercise test
Periods: 3months
Interventions/Control_2
Control group
Continued usucal daily life with recommended CKD management lifestyle
Periods: 3month
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Chronic kidney disease patients(CKD stage: G3a, G3b and G4) and not be applicable to exclusion criteria of exercise training recommended by guideline for Rehabilitation in Patients with Cardiovascular Disease (2012)
Key exclusion criteria
End stage renal failure with hemodialysis therapy, disable patients due to orthopedics or neuromuscular problem, active nephritis, patients with cognitive impairment, patients onset myocardial infarction, stroke, acute heart failure within 1 month or underwent cardiac surgery within 1 month, and keep stable condition at least 1 month, patients have possibility of use EPO during study period.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masakazu Saioth |
Organization
SAKAKIBARA HEART INSTITUTE HOSPITAL
Division name
Department of Physiotherapy
Zip code
Address
3-16-1, Asai-cho, Fuchu-shi, Tokyo
TEL
042-314-3111
msaitoh@shi.heart.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masakazu Saitoh |
Organization
SAKAKIBARA HEART INSTITUTE HOSPITAL
Division name
Department of Physiotherapy
Zip code
Address
3-16-1, Asai-cho, Fuchu-shi, Tokyo
TEL
042-314-3111
Homepage URL
msaitoh@shi.heart.or.jp
Sponsor or person
Institute
SAKAKIBARA HEART INSTITUTE HOSPITAL
Institute
Department
Personal name
Funding Source
Organization
Japan research promotion society for cardiovascular disease
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 10 | Month | 01 | 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
Completed
Date of protocol fixation
| 2014 | Year | 05 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 29 | Day |
Last modified on
| 2018 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017768
