UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052927 |
|---|---|
| Receipt number | R000060388 |
| Scientific Title | Comparison of two groups before and after the start of intervention regarding the effectiveness of intradialytic exercise therapy in outpatient dialysis patients |
| Date of disclosure of the study information | 2023/12/01 |
| Last modified on | 2024/04/08 21:40:43 |
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Basic information
Public title
The effect of exercise on outpatient dialysis patients
Acronym
The effect of exercise on outpatient dialysis patients
Scientific Title
Comparison of two groups before and after the start of intervention regarding the effectiveness of intradialytic exercise therapy in outpatient dialysis patients
Scientific Title:Acronym
Comparison of two groups before and after the start of intervention regarding the effectiveness of intradialytic exercise therapy in outpatient dialysis patients
Region
| Japan |
Condition
Condition
Chronic Kidney Disease
Classification by specialty
| Urology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We conducted a medical record survey of outpatient dialysis patients at our hospital who were eligible for additional benefits such as exercise guidance during dialysis, and compared the physical function evaluations conducted at the beginning and end of the additional calculation to verify the effectiveness of exercise therapy and to examine patient background information.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of Short Physical Performance Battery (SPPB) between two groups measured at the start of calculation of additional exercise guidance during dialysis and 90 days later
Key secondary outcomes
Verifying the correlation between dialysis efficiency, nutritional indicators, Elderly Status Assessment Set (E-SAS) results, and primary endpoints
Analysis of qualitative information (patient statements regarding exercise, patient questionnaires)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
At Ehime Prefectural Imabari Hospital, we calculated additional benefits such as exercise guidance during dialysis during the period from April 2023 to July 2023, and targeted outpatient dialysis patients who underwent supervised exercise therapy at our hospital.
Key exclusion criteria
Patients who meet the contraindications for exercise stress testing as stipulated in the "Kidney Rehabilitation Guidelines" or who have difficulty continuing exercise during the intervention period will be excluded.
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Mizuki |
| Middle name | |
| Last name | Inoue |
Organization
Ehime Prefectural Imabari Hospital
Division name
department of rehabilitation
Zip code
794-0006
Address
4-5-5 Ishiimachi, Imabari City, Ehime Prefecture
TEL
0898-32-7111
mi.inoue.0522@gmail.com
Public contact
Name of contact person
| 1st name | Mizuki |
| Middle name | |
| Last name | Inoue |
Organization
Ehime Prefectural Imabari Hospital
Division name
department of rehabilitation
Zip code
794-0006
Address
4-5-5 Ishiimachi, Imabari City, Ehime Prefecture
TEL
0898-32-7111
Homepage URL
mi.inoue.0522@gmail.com
Sponsor or person
Institute
Ehime Prefectural Imabari Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Ehime Prefectural Imabari Hospital Ethics Committee
Address
4-5-5 Ishiimachi, Imabari City, Ehime Prefecture
Tel
0898-32-7111
imabari-byoin@pref.ehime.lg.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
| 2023 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
18
Results
Pre- and post-comparison of SPPB measured at the beginning and at the end of 90 days after the calculation of the additional fee for exercise guidance during dialysis showed significant differences in the chair stand-up test and the total score. In the E-SAS results, the "human relations" item tended to be lower than the other items. A strong correlation was shown between initial SPPB and E-SAS total. No serious adverse events occurred throughout the intervention period.
Results date posted
| 2024 | Year | 04 | Month | 08 | Day |
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
| 2023 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
At Ehime Prefectural Imabari Hospital, we calculated additional benefits such as exercise guidance during dialysis during the period from April 2023 to July 2023, and targeted outpatient dialysis patients who underwent supervised exercise therapy at our hospital.Comparison of physical function evaluation (SPPB) measured at the beginning and end of calculation of exercise guidance during dialysis, etc. between two groups.
Management information
Registered date
| 2023 | Year | 11 | Month | 27 | Day |
Last modified on
| 2024 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060388
