UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020418 |
|---|---|
| Receipt number | 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 02:16:11 |
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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
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
huang.wanling@tsc.u-tokai.ac.jp
Sponsor or person
Institute
TOKAI UNIVERSITY HACHIOJI HOSRITAL
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023582
