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
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
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
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
