UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060822 |
|---|---|
| Receipt number | R000069595 |
| Scientific Title | A Study on the Effects of Exercise During Dialysis and Cognitive Function Interventions on Quality of Life in Elderly Dialysis Patients |
| Date of disclosure of the study information | 2026/03/05 |
| Last modified on | 2026/03/04 18:09:59 |
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Basic information
Public title
Effects of Exercise During Dialysis on Physical Function, Cognitive Function, and Quality of Life in Elderly Dialysis Patients
Acronym
Research on Exercise for Dialysis Patients
Scientific Title
A Study on the Effects of Exercise During Dialysis and Cognitive Function Interventions on Quality of Life in Elderly Dialysis Patients
Scientific Title:Acronym
Intradialytic Exercise study
Region
| Japan |
Condition
Condition
hemodialysis patients
Classification by specialty
| Nephrology | Geriatrics | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to clarify the effects of exercise interventions during dialysis on physical function, cognitive function, and quality of life in elderly dialysis patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive Function (MMSE, CogEvo)
Key secondary outcomes
Sarcopenia Assessment (AWGS2019)
Quality of Life (KDQOL-SF)
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
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
During hemodialysis, pedal exercise primarily targeting the lower limbs will be performed, and its effects will be evaluated. The intervention period is 6 weeks, conducted during dialysis three times per week. Each intervention session lasts approximately 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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Eligibility criteria for subjects included being 75 years of age or older, having undergone maintenance dialysis for at least 6 months at the time of study enrollment, and being in stable general health. Additionally, subjects must have minimal blood pressure fluctuations during dialysis and be capable of pedaling, as ergometers were used in this study.
Key exclusion criteria
Patients whose primary physician determined that exercise during dialysis poses a problem.
Other patients deemed unsuitable as research subjects by the principal investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Mitsu |
| Middle name | |
| Last name | Iso |
Organization
Kinjo University
Division name
Nursing
Zip code
924-0865
Address
1-250 Kuramitsu, Hakusan City, Ishikawa Prefecture
TEL
08042559152
namiwaka1004@gmail.com
Public contact
Name of contact person
| 1st name | Mitsue |
| Middle name | |
| Last name | Iso |
Organization
Kinjo University
Division name
Nursing
Zip code
924-0865
Address
1-250 Kuramitsu, Hakusan City, Ishikawa Prefecture
TEL
08042559152
Homepage URL
namiwaka1004@gmail.com
Sponsor or person
Institute
Kinjo University
Institute
Department
Personal name
Mitsue Iso
Funding Source
Organization
Japan Society for the Promotion of Science: JSPS
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kinjo Univesity
Address
1-250 Kuramitsu, Hakusan City, Ishikawa Prefecture
Tel
08042559152
namiwaka1004@gmail.com
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 | 03 | Month | 05 | Day |
Related information
URL releasing protocol
Not available
Publication of results
Unpublished
Result
URL related to results and publications
Not available
Number of participants that the trial has enrolled
10
Results
A dialysis exercise intervention was implemented for 10 elderly dialysis patients. While no significant changes were observed in the primary outcome measures of cognitive function (MMSE, CogEvo) before and after the intervention, significant improvements were noted in grip strength and in the "Overall Health Perception" and "Burden of Kidney Disease" subscales of the KDQOL-SF quality of life assessment. Regarding sarcopenia, the number of patients with severe sarcopenia decreased after the intervention.
Results date posted
| 2026 | Year | 03 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study included 10 elderly patients aged 75 years or older (all male, mean age 81.3 SD 4.9 years) undergoing maintenance hemodialysis.
Participant flow
Ten elderly dialysis patients who consented to participate in the study were enrolled. All subjects underwent the exercise intervention during dialysis and completed pre- and post-intervention assessments, making all 10 subjects eligible for analysis.
Adverse events
No serious adverse events related to the exercise intervention during dialysis were observed during the study period.
Outcome measures
Cognitive function (MMSE, CogEvo), quality of life (KDQOL-SF), sarcopenia assessment (AWGS2019), and physical function (SPPB), grip strength, and skeletal muscle mass (SMI) were evaluated.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 23 | 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 | 03 | Month | 04 | Day |
Last modified on
| 2026 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069595
