UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050382 |
|---|---|
| Receipt number | R000057369 |
| Scientific Title | Effects of renal rehabilitation on sleep status and physical activity of outpatients with end-stage kidney disease |
| Date of disclosure of the study information | 2023/03/01 |
| Last modified on | 2024/02/20 16:20:34 |
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Basic information
Public title
Effects of renal rehabilitation on sleep status and physical activity of outpatients with end-stage kidney disease
Acronym
Effects of renal rehabilitation on sleep status and physical activity of outpatients with end-stage kidney disease
Scientific Title
Effects of renal rehabilitation on sleep status and physical activity of outpatients with end-stage kidney disease
Scientific Title:Acronym
Effects of renal rehabilitation on sleep status and physical activity of outpatients with end-stage kidney disease
Region
| Japan |
Condition
Condition
end-stage renal disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
nvestigating the effects of renal rehabilitation on sleep status and physical activity level.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep status
Key secondary outcomes
physical activity level
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
| Behavior,custom | Maneuver |
Interventions/Control_1
stimulating awakening during dialysis, exercise during dialysis, nutritional guidance
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
patients with end-stage renal disease on outpatient maintenance dialysis
Key exclusion criteria
patients who are unable to walk independently
patients with dementia
patients not on maintenance dialysis 3 times a week
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Ishikawa |
Organization
Kobe University Graduate School of Health Science
Division name
Department of Public Health
Zip code
654-0142
Address
7-10-2, Tomogaoka, Suma-ku, Kobe Hyogo
TEL
078-796-4502
ishikawa@bear.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Ishikawa |
Organization
Kobe University Graduate School of Health Science
Division name
Department of Public Health
Zip code
654-0142
Address
7-10-2, Tomogaoka, Suma-ku, Kobe Hyogo
TEL
078-796-4502
Homepage URL
ishikawa@bear.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Health Science
Institute
Department
Personal name
Akira Ishikawa
Funding Source
Organization
Kobe University Graduate School of Health Science
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Graduate School of Health Science
Address
7-10-2, Tomogaoka, Suma-ku, Kobe Hyogo
Tel
078-796-4502
N/A
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
札幌ふしこ内科・透析クリニック（北海道）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | 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
Suspended
Date of protocol fixation
| 2022 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 02 | Month | 18 | Day |
Last modified on
| 2024 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057369
