UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040057 |
|---|---|
| Receipt number | R000045637 |
| Scientific Title | Impact of moderate-intensity exercise to renal function and exercise capacity of pre-dialysis chronic kidney disease patients. |
| Date of disclosure of the study information | 2020/04/08 |
| Last modified on | 2024/04/09 10:59:13 |
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Basic information
Public title
Impact of moderate-intensity exercise to renal function and exercise capacity of pre-dialysis chronic kidney disease patients.
Acronym
Impact of moderate-intensity exercise to renal function and exercise capacity of pre-dialysis chronic kidney disease patients.
Scientific Title
Impact of moderate-intensity exercise to renal function and exercise capacity of pre-dialysis chronic kidney disease patients.
Scientific Title:Acronym
Impact of moderate-intensity exercise to renal function and exercise capacity of pre-dialysis chronic kidney disease patients.
Region
| Japan |
Condition
Condition
pre-dialysis chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine the effect of moderate-intensity exercise to renal function and exercise capacity of pre-dialysis chronic kidney disease patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change rate of eGFR at 12 months
Key secondary outcomes
Change of exercise capacity at 12 months
Muscle mass measured by bioelectrical impedance analysis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
walking, 30 minites per day, 5 times per weeks
Interventions/Control_2
no intervention
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
eGFR 16-60 ml/min/1.73m2.
The patients who attend a hospital for more than 1 year.
Key exclusion criteria
The patients who need help during walking.
Hypermetabolism.
Acute on chronic kidney disease.
The patients who are suspected heart disease.
Heart failure (NYHA 2-4).
Acute myocardial infarction, congestive heart failure, or stroke during past 1 year.
Angina.
Intermittent claudication.
Chronic obstructive pulmonary disease.
Malignancy on treatment.
Mental disease or dimentia.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Okushima |
Organization
Osaka general medical center
Division name
Division of nephrology and hypertension
Zip code
558-8558
Address
3-1-56, Bandaihigashi,Sumiyoshi-ku, Osaka
TEL
06-6692-1201
h.okushima00@gmail.com
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Okushima |
Organization
Osaka general medical center
Division name
Division of nephrology and hypertension
Zip code
558-8558
Address
3-1-56, Bandaihigashi,Sumiyoshi-ku, Osaka
TEL
06-6692-1201
Homepage URL
h.okushima00@gmail.com
Sponsor or person
Institute
Osaka general medical center
Institute
Department
Personal name
Funding Source
Organization
no
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka general medical center, clinical research center
Address
3-1-56, Bandaihigashi,Sumiyoshi-ku, Osaka
Tel
06-6692-1201
kenkyusien@gh.opho.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
大阪急性期・総合医療センター
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 08 | 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
2
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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 03 | 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
Ongoing
participant:13
Management information
Registered date
| 2020 | Year | 04 | Month | 04 | Day |
Last modified on
| 2024 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045637
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
