UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058701 |
|---|---|
| Receipt number | R000067106 |
| Scientific Title | Effects of resistance exercise intervention during dialysis treatment on alertness and executive function in outpatient maintenance dialysis patients Randomized controlled trial |
| Date of disclosure of the study information | 2025/08/07 |
| Last modified on | 2025/08/05 08:46:58 |
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Basic information
Public title
The effect of exercise during dialysis treatment on cognitive function
Acronym
Intervention trial
Scientific Title
Effects of resistance exercise intervention during dialysis treatment on alertness and executive function in outpatient maintenance dialysis patients
Randomized controlled trial
Scientific Title:Acronym
Randomized controlled trial
Region
| Japan |
Condition
Condition
chronic renal failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of resistance exercise intervention during dialysis treatment on executive function in outpatient maintenance dialysis patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary endpoint was alertness during dialysis treatment. The psychomotor vigilance test, which assesses alertness, uses a tablet device to assess alertness quantitatively. The test was conducted within two hours of the start of dialysis, when vital signs were stable during dialysis. The subject pressed a button when numbers appeared on the device at irregular intervals over a three-minute period. The items measured included the mean and median reaction times and the number of failures.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Resistance exercise follows the report by Yabe et al., with the frequency of exercise being performed three times a week during dialysis visits, within two hours of the start of dialysis. Subjects were defined as moderately stressed at a perceived intensity of exertion13, and exercise was performed using three different types of rubber bands with different loads, tailored to the characteristics of each subject. Four types of resistance exercise using stretching and Therabands were performed, with three sets of 10 repetitions each, over a 90-day period. Regular treatment refers to the series of treatments for outpatient maintenance dialysis patients, from puncture to hemostasis.
Interventions/Control_2
Conventional treatment refers to a series of treatments for outpatient maintenance dialysis patients, from puncture to hemostasis.
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
| 18 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The subjects were 1,100 maintenance dialysis patients who visit Seijinkai Medical Corporation as outpatients and who gave their consent to participate in this study.
Key exclusion criteria
Those with severe dementia who are unable to understand oral or written instructions on how to measure, or who have motor paralysis in the non-shunted limb or both upper limbs and have difficulty operating the measurement device.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Nishida |
Organization
International University of Health and Welfare
Division name
School of Health Sciences at Narita
Zip code
286-8686
Address
4-3, Kozunomori, Narita-shi,Chiba-ken.
TEL
0476-20-7701
yuusuken@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Ryohei |
| Middle name | |
| Last name | Yamaguchi |
Organization
Seijinkai Medical Corporation Mihama Hospital
Division name
rehabilitation department
Zip code
261-0013
Address
1-1-5 Utase, Mihama-ku, Chiba City, Chiba Prefecture
TEL
043-271-2288
Homepage URL
24s3061@g.iuhw.ac.jp
Sponsor or person
Institute
Seijinkai Medical Corporation Mihama Hospital
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
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
Seijinkai Medical Corporation Mihama Hospital
Address
1-1-5 Utase, Mihama-ku, Chiba City, Chiba Prefecture
Tel
043-271-2288
24s3061@g.iuhw.ac.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
| 2025 | Year | 08 | Month | 07 | 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
| 2025 | Year | 08 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 08 | Month | 05 | Day |
Last modified on
| 2025 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067106
