UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037460 |
|---|---|
| Receipt number | 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 | 2023/04/07 18:49:16 |
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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
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
ushiogi.yasuyuki3001@fukui.saiseikai.or.jp
Sponsor or person
Institute
fukui saiseikai hospital
Institute
Department
Personal name
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
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
| 2023 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042707
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
