UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038313 |
|---|---|
| Receipt number | R000043639 |
| Scientific Title | Effect of intradialytic exercise in hemodialysis patients |
| Date of disclosure of the study information | 2019/11/01 |
| Last modified on | 2021/04/17 10:07:32 |
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Basic information
Public title
Effect of intradialytic exercise in hemodialysis patients
Acronym
Effect of intradialytic exercise in hemodialysis patients
Scientific Title
Effect of intradialytic exercise in hemodialysis patients
Scientific Title:Acronym
Effect of intradialytic exercise in hemodialysis patients
Region
| Japan |
Condition
Condition
End stage kidney disease
Classification by specialty
| Nephrology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We assess potential factors which affect the effect of intradialytic exercise for sarcopenia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle mass, muscle strength, and physical performance six months after the initiation of intradialytic exercise
Key secondary outcomes
Index of depression, frailty index and nutritional data six months after the initiation of intradialytic exercise
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
Intradialytic exercise
Resistance training and aerobic exercise
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hemodialysis patients
Key exclusion criteria
Patients with severe cardiovascular disease
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Takizawa |
Organization
Teine Keijinkai Hospital
Division name
Devision of nephrology
Zip code
006-0811
Address
1-12, Maeda, Teine-ku, Sapporo, Hokkaido, Japan
TEL
011-681-8111
takizawa.tdr@keijinkai.or.jp
Public contact
Name of contact person
| 1st name | Takuto |
| Middle name | |
| Last name | Maeda |
Organization
Teine Keijinkai Hospital
Division name
Devision of nephrology
Zip code
006-0811
Address
1-12, Maeda, Teine-ku, Sapporo, Hokkaido, Japan
TEL
011-681-8111
Homepage URL
maeda-ta@keijinkai.or.jp
Sponsor or person
Institute
Teine keijinkai hospital
Institute
Department
Personal name
Funding Source
Organization
No
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
Teine keijinkai hospital
Address
1-12, Maeda, Teine-ku, Sapporo, Hokkaido, Japan
Tel
011-681-8111
teine@keijinkai.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 | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2022 | 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
| 2019 | Year | 10 | Month | 16 | Day |
Last modified on
| 2021 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043639
| 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 |
