UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035706 |
|---|---|
| Receipt number | R000034255 |
| Scientific Title | Consideration for immediate reaction of therapeutic exercise under hemodialysis ~Verification by the fluctuation of salivary amylase of a astressmarker~ |
| Date of disclosure of the study information | 2020/09/30 |
| Last modified on | 2019/09/27 19:05:18 |
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Basic information
Public title
Consideration for immediate reaction of therapeutic exercise under hemodialysis
~Verification by the fluctuation of salivary amylase of a astressmarker~
Acronym
Consideration for immediate reaction of therapeutic exercise under hemodialysis
~Verification by the fluctuation of salivary amylase of a astressmarker~
Scientific Title
Consideration for immediate reaction of therapeutic exercise under hemodialysis
~Verification by the fluctuation of salivary amylase of a astressmarker~
Scientific Title:Acronym
Consideration for immediate reaction of therapeutic exercise under hemodialysis
~Verification by the fluctuation of salivary amylase of a astressmarker~
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effectiveness of exercise therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Saliva amylase under hemodialysis
Key secondary outcomes
blood pressure
heart rate
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
In this study, we randomly allocate two groups of exercise therapy period and control period.In exercise therapy, implement ergometer of carry out two sets of fifteen minutes during hemodialysis.This study intervenes in three days of the dialysis day.
Interventions/Control_2
The wash out period of one week, the treatment is replaced, carried out for one week, the observation period is one week, and end.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Hemodialysis patients who have visiting our hospital for over a month.
2.Patients with stable water removal in hemodialysis.
3.Patients who can perform ergometer exercise set in this study.
4.Patients who can obtain written consent to participate in research by freedom intent.
Key exclusion criteria
1.Patients who poor water removal by hemodialysis.
2.Patients who are using vasopressor to low blood pressure seen by hemodialysis.
3.Patients who difficult of ergometer exercise by severe movement disorders.
4.Patients who severe neuropathy by diabetic nephropathy.
5.Patients who suspected of dementia(HDS-R less than 20).
6.During exercise ,patients who can not hear the main complaint.
7.Patients who can not obtain consent to participate in research.
8.Other, patients who judged inappropriate by the attending physician or kidney lnternal physician.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Eigo |
| Middle name | |
| Last name | Kobayashi |
Organization
Seiyuukai Shinnmei Hospital
Division name
Rehabilitation Department
Zip code
674-0051
Address
Akashi city Ohkubo Ookubo 2920
TEL
078-935-9000
vrku61257@zeus.eonet.ne.jp
Public contact
Name of contact person
| 1st name | Eigo |
| Middle name | |
| Last name | Kobayashi |
Organization
Seiyuukai Shinnmei Hospital
Division name
Rehabilitation Department
Zip code
674-0051
Address
Akashi city Ohkubo Ookubo 2920
TEL
078-935-9000
Homepage URL
vrku61257@zeus.eonet.ne.jp
Sponsor or person
Institute
Seiyuukai Shinnmei Hospital
Institute
Department
Personal name
Funding Source
Organization
Seiyuukai Shinnmei Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shinnmei Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Seiyuukai Shinnmei Hospital
Address
Akashi city Ohkubo Ookubo 2920
Tel
078-935-9000
vrku61257@zeus.eonet.ne.jp
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
| 2020 | Year | 09 | Month | 30 | 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 | 03 | Month | 14 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 28 | Day |
Last modified on
| 2019 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034255
