UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031938 |
|---|---|
| Receipt number | R000036084 |
| Scientific Title | Examination of factors constituting fatigue of patients with maintenance dialysis patients and verification of effects of aerobic exercise to improve fatigue |
| Date of disclosure of the study information | 2018/03/29 |
| Last modified on | 2020/10/19 19:51:08 |
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Basic information
Public title
Examination of factors constituting fatigue of patients with maintenance
dialysis patients and verification of effects of aerobic exercise to improve
fatigue
Acronym
study on fatigue in patients with maintenance dialysis
Scientific Title
Examination of factors constituting fatigue of patients with maintenance
dialysis patients and verification of effects of aerobic exercise to improve
fatigue
Scientific Title:Acronym
study on fatigue in patients with maintenance dialysis
Region
| Japan |
Condition
Condition
maintenance dialysis patients
Classification by specialty
| Nephrology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
exercise establishes as one of the evidence approaches to fatigue of dialysis patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
fatigability
Key secondary outcomes
Physical activity, Lower limb muscle, Fatigue, Depression
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
aerobic exercise during hemodialysis for two 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Able to ambulate
2) Capable of giving informed consent
Key exclusion criteria
1) Hospitalization within 3 months prior to study enrollment
2)Duration of maintenance hemodialysis less
than 3 months
3)Evidence of active malignancy
4)Those who are told refrain from exercising
5)Leg amputation
6)Those who have difficulty understanding instruction
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Nishida |
| Middle name | |
| Last name | yuusuke |
Organization
International University of Health and Welfare
Division name
Health Science at Narita Department of Physical Therapy
Zip code
286-8686
Address
4-3 Kozunomori, Narita city, Chiba 286-8686 Japan
TEL
0476-20-7701
yuusuken@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Takeki |
| Middle name | |
| Last name | Ishida |
Organization
Graduate School of International University of Health and Welfare
Division name
Department of Health and Science, Health and Welfare Science Course
Zip code
286-8686
Address
4-3 Kozunomori, Narita city, Chiba 286-8686 Japan
TEL
0476-20-7701
Homepage URL
17S3008@g.iuhw.ac.jp
Sponsor or person
Institute
Graduate School of International University of Health and Welfare
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
Graduate School of International University of Health and Welfare
Address
4-3 Kozunomori, Narita city, Chiba 286-8686 Japan
Tel
0476-20-7701
s-rinri@iuhw.ac.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
| 2018 | Year | 03 | Month | 29 | 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
| 2018 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | 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
| 2018 | Year | 03 | Month | 28 | Day |
Last modified on
| 2020 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036084
