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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038313
Receipt No. R000043639
Scientific Title Effect of intradialytic exercise in hemodialysis patients
Date of disclosure of the study information 2019/11/01
Last modified on 2019/10/16

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Basic information
Public title Effect of intradialytic exercise in hemodialysis patients
Acronym Effect of intradialytic exercise in hemodialysis patients
Scientific Title Effect of intradialytic exercise in hemodialysis patients
Scientific Title:Acronym Effect of intradialytic exercise in hemodialysis patients
Region
Japan

Condition
Condition End stage kidney disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We assess potential factors which affect the effect of intradialytic exercise for sarcopenia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Muscle mass, muscle strength and physical performance six months after the initiation of intradialytic exercise
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Intradialytic exercise
Resistance training and aerobic exercise
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Hemodialysis patients
Key exclusion criteria Patients with severe cardiovascular disease
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Hideki
Middle name
Last name Takizawa
Organization Teine Keijinkai Hospital
Division name Devision of nephrology
Zip code 006-0811
Address 1-12, Maeda, Teine-ku, Sapporo, Hokkaido, Japan
TEL 011-681-8111
Email takizawa.tdr@keijinkai.or.jp

Public contact
Name of contact person
1st name Koki
Middle name
Last name Abe
Organization Teine Keijinkai Hospital
Division name Devision of nephrology
Zip code 006-0811
Address 1-12, Maeda, Teine-ku, Sapporo, Hokkaido, Japan
TEL 011-681-8111
Homepage URL
Email a.abe@sapmed.ac.jp

Sponsor
Institute Teine keijinkai hospital
Institute
Department

Funding Source
Organization No
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 Teine keijinkai hospital
Address 1-12, Maeda, Teine-ku, Sapporo, Hokkaido, Japan
Tel 011-681-8111
Email teine@keijinkai.or.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
2019 Year 11 Month 01 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
2019 Year 10 Month 01 Day
Date of IRB
2019 Year 10 Month 10 Day
Anticipated trial start date
2019 Year 11 Month 01 Day
Last follow-up date
2022 Year 03 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
2019 Year 10 Month 16 Day
Last modified on
2019 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043639

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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