UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063446 |
|---|---|
| Receipt number | R000072616 |
| Scientific Title | Introduction of Exercise Therapy at the Dialysis Center An Initiative Focusing on Changes in Motor Function and Daily Living Conditions |
| Date of disclosure of the study information | 2026/10/29 |
| Last modified on | 2026/10/28 16:43:34 |
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Basic information
Public title
Introduction of Exercise Therapy at the Dialysis Center An Initiative Focusing on Changes in Motor Function and Daily Living Conditions
Acronym
Introduction of Exercise Therapy at the Dialysis Center An Initiative Focusing on Changes in Motor Function and Daily Living Conditions
Scientific Title
Introduction of Exercise Therapy at the Dialysis Center An Initiative Focusing on Changes in Motor Function and Daily Living Conditions
Scientific Title:Acronym
Introduction of Exercise Therapy at the Dialysis Center An Initiative Focusing on Changes in Motor Function and Daily Living Conditions
Region
| Japan |
Condition
Condition
chronic renal failure
Classification by specialty
| Nephrology | Rehabilitation medicine | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Dialysis patients are prone to a decline in muscle strength and physical activity due to the effects of prolonged rest and fatigue resulting from dialysis treatment. By introducing exercise therapy at dialysis centers, this study aims to clarify changes in patients physical function and quality of life, as well as to investigate how their attitudes toward exercise change, with the goal of using these findings to support their ongoing exercise regimens.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
laboratory test data (Alb, Hb, P, GA, total protein), dry weight (DW), BMI, Kt/V, symptoms (palpitations, shortness of breath, dizziness), sleep status, grip strength, lower-limb circumference, and questionnaire-based assessments (at the start of the exercise program and one year later).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Implementation of an exercise program consisting of three sessions per week, each lasting about 20 minutes
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
(1) Patients currently receiving treatment at our hospital's dialysis center (2) Patients who understand the nature of this study and are willing to give their consent
Key exclusion criteria
(1) Patients who fall under the contraindications for exercise therapy as outlined in the Guidelines for Exercise Therapy in Heart Disease(2) Patients with dementia or mental illness, those with active bleeding, or those experiencing pain (3) Patients from whom consent cannot be obtained
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | TOMO |
| Middle name | |
| Last name | NAKAMURA |
Organization
National Hospital Organization Kanmon Medical Center
Division name
Nursing Department Dialysis Center
Zip code
7528510
Address
1-1 Chofu-Sotoura-cho, Shimonoseki City, Yamaguchi Prefecture
TEL
0832411199
nakamura.tomo.kv@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | TOMO |
| Middle name | |
| Last name | NAKAMURA |
Organization
National Hospital Organization Kanmon Medical Center
Division name
Dialysis Center
Zip code
7528510
Address
1-1 Chofu-Sotoura-cho, Shimonoseki City, Yamaguchi Prefecture
TEL
0832411199
Homepage URL
nakamura.tomo.kv@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Kanmon Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Kanmon Medical Center
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
National Hospital Organization Kanmon Medical Center
Address
1-1 Chofu-Sotoura-cho, Shimonoseki City, Yamaguchi Prefecture
Tel
0832411199
nakamura.tomo.kv@mail.hosp.go.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
| 2026 | Year | 10 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 29 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 10 | Month | 28 | Day |
Last modified on
| 2026 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072616
