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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000037460
Receipt No. R000042707
Scientific Title Efficacy of exercse therapy for sarcopenia preventionin dialysis patients
Date of disclosure of the study information 2019/07/25
Last modified on 2020/02/03

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Basic information
Public title Efficacy of exercse therapy for sarcopenia preventionin dialysis patients
Acronym Efficacy of exercse therapy for sarcopenia preventionin dialysis patients
Scientific Title Efficacy of exercse therapy for sarcopenia preventionin dialysis patients
Scientific Title:Acronym Efficacy of exercse therapy for sarcopenia preventionin dialysis patients
Region
Japan

Condition
Condition chronic kidney disease
Classification by specialty
Nephrology Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigation of the effects by exercise therapy with ergometer on the motor function, activity of daily living and nutritional status in dialysis patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of motor function by six-minutes walking distance and stand-up test,
evaluation of activity of daily living by Barthel Index
Key secondary outcomes Lean body mass and skeletal muskle mass measurements with Bioelectrical impedance analysis, and skin perfusion pressure

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Exercise therapy with ergometer
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 Hemodialysis patients
Key exclusion criteria cachectic state of malignancy
progressed liver dysfunction
pregnancy
stage 3-4 cardiac failure
active infection
unable to walk
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Yasuyuki
Middle name
Last name Ushiogi
Organization fukui saiseikai hospital
Division name Blood purification center
Zip code 828-8503
Address Wadanaka-cho Funabashi 7-1 Fukui Pref. Japan
TEL 0776-23-1111
Email ushiogi.yasuyuki3001@fukui.saiseikai.or.jp

Public contact
Name of contact person
1st name Yasuyuki
Middle name
Last name Ushiogi
Organization fukui saiseikai hospital
Division name Blood purification center
Zip code 918-8503
Address Wadanaka-cho Funabashi 7-1 Fukui Pref. Japan
TEL 0776-23-1111
Homepage URL
Email ushiogi.yasuyuki3001@fukui.saiseikai.or.jp

Sponsor
Institute fukui saiseikai hospital
Institute
Department

Funding Source
Organization fukui saiseikai hospital
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization hukui saiseikai hospital
Address Wadanaka-cho Funabashi 7-1 Fukui Pref. Japan
Tel 0776-23-1111
Email ushiogi.yasuyuki3001@fukui.saiseikai.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 07 Month 25 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 07 Month 10 Day
Date of IRB
2019 Year 07 Month 10 Day
Anticipated trial start date
2019 Year 07 Month 11 Day
Last follow-up date
2023 Year 07 Month 10 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 07 Month 23 Day
Last modified on
2020 Year 02 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042707

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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