UMIN-CTR Clinical Trial

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
Email	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
Email	vrku61257@zeus.eonet.ne.jp

Sponsor
Institute	Seiyuukai Shinnmei Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034255