UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005091 |
|---|---|
| Receipt number | R000006052 |
| Scientific Title | Randomized controlled pilot trial for the clinical utility of exercise therapy in patients with CKD |
| Date of disclosure of the study information | 2011/02/15 |
| Last modified on | 2015/08/18 14:38:04 |
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Basic information
Public title
Randomized controlled pilot trial for the clinical utility of exercise therapy in patients with CKD
Acronym
Clinical utility of exercise therapy in patients with CKD
Scientific Title
Randomized controlled pilot trial for the clinical utility of exercise therapy in patients with CKD
Scientific Title:Acronym
Clinical utility of exercise therapy in patients with CKD
Region
| Japan |
Condition
Condition
Chronic kidney disease stage 3 - 5
Classification by specialty
| Cardiology | Nephrology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the favorable effects of long-term sustainable exercise therapy on the rate of kidney function decline, incidence of cardiovascular disease, and motor function in CKD patients with renal dysfunction
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of kidney function decline
Incidence of cardiovascular disease
Motor function (muscle strength and exercise capacity)
Key secondary outcomes
Initiation of dialysis or death
Changes in blood pressure level
Changes in urinary protein level
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
More than 8,000 steps everyday with moderate degree of exercise three times a week
Interventions/Control_2
normal daily activities
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
| 30 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male
Key inclusion criteria
1. Male patients with stable CKD between 30 and 80 years of age
2. CKD stage 3 to 5; eGFR < 60 ml/min
3. Patients with written informed consent after receiving a full explanation
4. Patients with independent ADL without apparent dementia
Key exclusion criteria
1. Dialysis patient with renal failure
2. Renal transplant patient
3. Patient having a feeling of residual urine
4. Patient judged to be inappropriate by the charge doctor
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yugo Shibagaki |
Organization
St. Marianna University School of Medicine
Division name
Department of Medicine, Division of Nephrology & Hypertension
Zip code
Address
2-16-1 Sugao Miyamae-ku, Kawasaki, 216-8511, Japan
TEL
044-977-8111
shibagaki@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Hiraki |
Organization
St. Marianna University School of Medicine
Division name
Department of rehabilitation
Zip code
Address
2-16-1 Sugao Miyamae-ku, Kawasaki, 216-8511, Japan
TEL
044-977-8111
Homepage URL
hiraki7@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of medicine Department of Medicine Division of Nephrology & Hypertension
Institute
Department
Personal name
Funding Source
Organization
None
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
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
聖マリアンナ医科大学病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 15 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 01 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | 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
| 2011 | Year | 02 | Month | 15 | Day |
Last modified on
| 2015 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006052
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
