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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000005091
Receipt No. 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

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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
Email 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
Email hiraki7@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of medicine Department of Medicine Division of Nephrology & Hypertension
Institute
Department

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
Email

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
URL(English) https://upload.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
Registered date File name


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