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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000020418
Receipt No. R000023582
Scientific Title The Relation Between Exercise Therapy and Quality of Life of Maintance Dialysis
Date of disclosure of the study information 2016/10/01
Last modified on 2016/01/03

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Basic information
Public title The Relation Between Exercise Therapy and Quality of Life of Maintance Dialysis
Acronym The Relation Between Exercise Therapy and Quality of Life
Scientific Title The Relation Between Exercise Therapy and Quality of Life of Maintance Dialysis
Scientific Title:Acronym The Relation Between Exercise Therapy and Quality of Life
Region
Japan

Condition
Condition Maintance Dialysis Patient
Classification by specialty
Nephrology Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The related to the improvement of QOL and bodily functions by the exercise therapy of maintance patients are obviously.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Assessment of QUALITY of life KDQOL-SFver1.3 be used. Kidney disease specific measure for 8 items, non-health related measures for 3 items, a comprehensive scale for 8 items (78 question of the totally)
Key secondary outcomes 1. isokinetic evaluation:CS-30
2. physical assessment:
Dialysis efficiency(Kt/V),
foot-brachial Index (ABI), hemodynamic (blood pressure and oxygen saturation measured with exercise therapy before and after)
3.exercise therapy before and after subjective evaluation: lower extremity of presence and feelings of fatigue and shortness of breath with or without

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 15 hemodialysis patients, aerobic exercise and muscle-strengthening exercise during dialysis .The period is 6 months
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
49 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria 1.The dialysis patients outside in
Hospital
2. patients with consciousness clear 3.No excise limitations
4.dialysis in patients with low blood pressure in patients with lower legs
5.patients be assure by doctor
6. To participate in this study received sufficient information, obtained the written consent by the free will of the individual
Key exclusion criteria Investigator or investigator be inappropriate as determined
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Wan-Ling Huang
Organization TOKAI UNIVERSITY HACHIOJI HOSRITAL
Division name NURSING
Zip code
Address 1838 Ishikawa Hachioji city Tokyo
TEL 042-639-1111
Email Huang.wanling@tsc.u-tokai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Wan-Ling Huang
Organization TOKAI UNIVERSITY HACHIOJI HOSRITAL
Division name NURSEING
Zip code
Address 1838 Ishikawa Hachioji city Tokyo
TEL 042-639-1111
Homepage URL
Email huang.wanling@tsc.u-tokai.ac.jp

Sponsor
Institute TOKAI UNIVERSITY HACHIOJI HOSRITAL
Institute
Department

Funding Source
Organization None
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
Address
Tel
Email

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 東海大学医学部付属八王子病院 (東京都) TOKAI UNIVERSITY HACHIOJI HOSRITA(Tokyo)

Other administrative information
Date of disclosure of the study information
2016 Year 10 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 Preinitiation
Date of protocol fixation
2015 Year 12 Month 16 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 01 Day
Last follow-up date
2016 Year 06 Month 30 Day
Date of closure to data entry
2016 Year 07 Month 31 Day
Date trial data considered complete
2016 Year 07 Month 31 Day
Date analysis concluded
2016 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 01 Month 03 Day
Last modified on
2016 Year 01 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023582

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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