UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037895 |
|---|---|
| Receipt number | R000043146 |
| Scientific Title | Approach and effect for QOL improvement by exercise therapy intervention during dialysis |
| Date of disclosure of the study information | 2019/09/02 |
| Last modified on | 2020/06/02 01:01:59 |
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Basic information
Public title
Approach and effect for QOL improvement by exercise therapy intervention during dialysis
Acronym
Effects of exercise therapy during dialysis
Scientific Title
Approach and effect for QOL improvement by exercise therapy intervention during dialysis
Scientific Title:Acronym
Effects of exercise therapy during dialysis
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology | Rehabilitation medicine | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
ADL maintenance and QOL improvement such as maintenance of lower limb muscle strength and increased activity in daily life through exercise therapy intervention during dialysis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1.Health-related quality of life
Key secondary outcomes
2.Leg strength
3.Sleep evaluation
4.Behavior transformation stage
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Exercise every hamodialysis
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Outpatient hemodialysis patients who do not have exercise habits and have lower leg muscle strength
Key exclusion criteria
1.Person who cannot walk even if we use welfare tool
2.Unstable cardiovascular disease
3.Person with arteriosclerosis obliterans
4.Patients with lumbar disease such as lumbar spinal canal stenosis and lumbar disc herniation
5.Patients with cognitive impairment
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ai |
| Middle name | |
| Last name | Horimoto |
Organization
Kawashima Hospital
Division name
Artificial dialysis
Zip code
770-0011
Address
1-39Kitasakoichiban-cho, Tokushima city , Tokushima, Japan
TEL
088-631-0110
moonar325@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Ai |
| Middle name | |
| Last name | Horimoto |
Organization
Kawashima Dialysis Clinic
Division name
Artificial dialysis
Zip code
770-0011
Address
1-39 Kitasakoichiban-cho, Tokushima city , Tokushima, Japan
TEL
088-631-0110
Homepage URL
moonar325@yahoo.co.jp
Sponsor or person
Institute
Kawashima Hospital
Institute
Department
Personal name
Funding Source
Organization
Kawashima Hospital
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
Kawashima Hospital
Address
1-39 Kitasakoichiban-cho, Tokushima city , Tokushima, Japan
Tel
088-631-0110
sasaka@khg.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
川島病院（徳島県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 02 | 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
6
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
Completed
Date of protocol fixation
| 2019 | Year | 04 | Month | 16 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2019 | Year | 10 | 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
| 2019 | Year | 09 | Month | 02 | Day |
Last modified on
| 2020 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043146
