UMIN-CTR Clinical Trial

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