UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033356
Receipt number R000037992
Scientific Title 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 2023/08/14 16:11:35

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Basic information

Public title

Effect of preoperative handgrip exercise on vessel diameter in patients with end-stage renal disease : a multicenter randomized controlled trial

Acronym

Effect of preoperative handgrip exercise on vessel diameter in patients with end-stage renal disease : a multicenter randomized controlled trial

Scientific Title

Effect of preoperative handgrip exercise on vessel diameter in patients with end-stage renal disease : a multicenter randomized controlled trial

Scientific Title:Acronym

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

1st name MASAAKI
Middle name
Last name Masaaki Murakami

Organization

Shizuoka General Hospital

Division name

Department of Nephrology

Zip code

420-8527

Address

4-27-1 Kitaando, Aoiku, Shizuoka, Shizuoka

TEL

054-247-6111

Email

mmurakami77207@gmail.com


Public contact

Name of contact person

1st name MASAAKI
Middle name
Last name Masaaki Murakami

Organization

Shizuoka General Hospital

Division name

Department of Nephrology

Zip code

420-8527

Address

4-27-1 Kitaando, Aoiku, Shizuoka, Shizuoka

TEL

054-247-6111

Homepage URL


Email

mmurakami77207@gmail.com


Sponsor or person

Institute

Shizuoka General Hospital

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization

Shizuoka General Hospital

Address

4-27-1 Kitaando, Aoiku, Shizuoka, Shizuoka

Tel

0542476111

Email

mmurakami77207@gmail.com


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


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

Enrolling by invitation

Date of protocol fixation

2018 Year 05 Month 01 Day

Date of IRB

2018 Year 06 Month 12 Day

Anticipated trial start date

2018 Year 08 Month 01 Day

Last follow-up date

2029 Year 07 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 07 Month 10 Day

Last modified on

2023 Year 08 Month 14 Day



Link to view the page

Value
https://center6.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