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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033356
Receipt No. R000037992
Official scientific title of the study Effect of preoperative handgrip exercise on vessel diameter in patients with end-stage renal disease : a multicenter randomized controlled trial
Date of disclosure of the study information 2018/07/12
Last modified on 2018/07/10

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Basic information
Official scientific title of the study Effect of preoperative handgrip exercise on vessel diameter in patients with end-stage renal disease : a multicenter randomized controlled trial
Title of the study (Brief title) Effect of preoperative handgrip exercise on vessel diameter in patients with end-stage renal disease : a multicenter randomized controlled trial
Region
Japan

Condition
Condition end-stage renal disease
Classification by specialty
Nephrology Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy of preoperative handgrip exercise on vessel diameter in patients with end-stage renal disease
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes diameters of the artery before and after handgrip exercise
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 preoperative handgrip exercise
Interventions/Control_2 control
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. Necessity for planning to create vascular access
2. Age >= 20 years old
3. Willingness to provided written informed consent



Key exclusion criteria 1. Concomitant disease (e.g., terminal cancer or systemic severe infection) result in death within 1 year
2. Patients who will undergo kidney transplantation within 1 year
3. Previous arteriovenous access creation
4. Disability to perform handgrip exercise physically or psychologically
5. Difficulty for vascular access creation due to severe heart failure, hand ischemia, or central venous stenosis/occlusion
Target sample size 190

Research contact person
Name of lead principal investigator Masaaki Murakami
Organization Shizuoka General Hospital
Division name Department of Nephrology
Address 4-27-1 Kitaando, Aoiku, Shizuoka, Shizuoka
TEL 054-247-6111
Email mmurakami77207@gmail.com

Public contact
Name of contact person Masaaki Murakami
Organization Shizuoka General Hospital
Division name Department of Nephrology
Address 4-27-1 Kitaando, Aoiku, Shizuoka, Shizuoka
TEL 054-247-6111
Homepage URL
Email mmurakami77207@gmail.com

Sponsor
Institute Shizuoka General Hospital
Institute
Department

Funding Source
Organization Shizuoka General Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2018 Year 07 Month 12 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 05 Month 01 Day
Anticipated trial start date
2018 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 07 Month 10 Day
Last modified on
2018 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037992

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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