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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043318
Receipt No. R000047967
Scientific Title Effect of the exercise therapy during hemodialysis on the patients of arteriosclerosis obliterans
Date of disclosure of the study information 2021/03/31
Last modified on 2021/02/13

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Basic information
Public title Effect of the exercise therapy during hemodialysis on the patients of arteriosclerosis obliterans
Acronym Effect of the exercise therapy during hemodialysis
Scientific Title Effect of the exercise therapy during hemodialysis on the patients of arteriosclerosis obliterans
Scientific Title:Acronym Effect of the exercise therapy during hemodialysis
Region
Japan

Condition
Condition arteriosclerosis obliterans
Classification by specialty
Nephrology Vascular surgery Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to investigate whether exercise therapy during hemodialysis prevents deterioration of activities of daily life, maintains muscle strength, increases peripheral circulation, and shortens the length of hospitalization.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes increase of peripheral circulation oxygen and partial pressure by exercise therapy during hemodialysis
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 exercise therapy during hemodialysis
Interventions/Control_2
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) inpatients with ASO Rutherford criteria
Key exclusion criteria bed-bound patient
Target sample size 10

Research contact person
Name of lead principal investigator
1st name SATO
Middle name
Last name MIYU
Organization TOKYO MEDICAL AND DENTAL UNIVERSITY MEDICAL HOSPITAL
Division name Blood purification therapy department
Zip code 1138519
Address 1-5-45 Yushima Bunkyo-ku Tokyo
TEL 0338135662
Email m.fujimaki.mnrs@tmd.ac.jp

Public contact
Name of contact person
1st name SATO
Middle name
Last name MIYU
Organization TOKYO MEDICAL AND DENTAL UNIVERSITY MEDICAL HOSPITAL
Division name Blood purification therapy department
Zip code 1138519
Address 1-5-45 Yushima Bunkyo-ku Tokyo
TEL 0338135662
Homepage URL
Email m.fujimaki.mnrs@tmd.ac.jp

Sponsor
Institute Ministry of education
Institute
Department

Funding Source
Organization TOKYO MEDICAL AND DENTAL UNIVERSITY MEDICAL HOSPITAL Nephrology
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization TOKYO MEDICAL AND DENTAL UNIVERSITY MEDICAL HOSPITAL Blood purification therapy department
Address 1-5-45 Yushima Bunkyo-ku Tokyo
Tel 0338135662
Email m.fujimaki.mnrs@tmd.ac.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
2021 Year 03 Month 31 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 Preinitiation
Date of protocol fixation
2020 Year 04 Month 30 Day
Date of IRB
Anticipated trial start date
2021 Year 03 Month 20 Day
Last follow-up date
2021 Year 04 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
2021 Year 02 Month 13 Day
Last modified on
2021 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047967

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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