UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019010 |
|---|---|
| Receipt number | R000021989 |
| Scientific Title | Association between muscle cramps and physical active mass in the dialysis in the hemodialysis patient |
| Date of disclosure of the study information | 2015/09/14 |
| Last modified on | 2020/05/02 19:46:06 |
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Basic information
Public title
Association between muscle cramps and physical active mass in the dialysis in the hemodialysis patient
Acronym
Association between muscle cramps and physical active mass in the dialysis of the hemodialysis patient
-Exercise instruction effect inspection-
Scientific Title
Association between muscle cramps and physical active mass in the dialysis in the hemodialysis patient
Scientific Title:Acronym
Association between muscle cramps and physical active mass in the dialysis of the hemodialysis patient
-Exercise instruction effect inspection-
Region
| Japan |
Condition
Condition
hemodialysis
Classification by specialty
| Nephrology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
I examine an association between muscle cramps and physical active mass in the dialysis of the hemodialysis patient and inspect an effect of the exercise instruction intervention
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1.Physical active mass
Key secondary outcomes
2.Knee extension muscular strength
3.Health-related QOL
4.Activity of daily living
5.Behavior therapy
6.Other laboratory data and examination for motor ability
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
I exercise and instruct it and am improved muscle cramps
Interventions/Control_2
I exercise and instruct it
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
The possible person who stands alone of foreign hemodialysis
Key exclusion criteria
Walking alone impossibility
Leg amputation
Dementia
Unstable complications
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Tamatani |
Organization
Kawashima Hospital
Division name
Department of rehabilitation
Zip code
Address
1-1-39 Kitasako,Tokushima,770-8548,Japan
TEL
088-631-0110
takahiro1208@mf.pikara.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Tamatani |
Organization
Kawashima Hospital
Division name
Department of rehabilitation
Zip code
Address
1-1-39 Kitasako,Tokushima,770-8548,Japan
TEL
088-631-0110
Homepage URL
takahiro1208@mf.pikara.ne.jp
Sponsor or person
Institute
Kawashima Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
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
川島透析クリニック(徳島県)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 14 | 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
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2016 | Year | 12 | 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
| 2015 | Year | 09 | Month | 14 | Day |
Last modified on
| 2020 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021989
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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