UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058701 |
|---|---|
| Receipt number | R000067106 |
| Scientific Title | Effects of Intradialytic Resistance Exercise on Alertness and Executive Function in Outpatients Undergoing Maintenance Hemodialysis |
| Date of disclosure of the study information | 2025/08/07 |
| Last modified on | 2026/10/31 14:47:35 |
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Basic information
Public title
Effects of Intradialytic Resistance Exercise on Alertness and Executive Function in Outpatients Undergoing Maintenance Hemodialysis
Acronym
Intervention trial
Scientific Title
Effects of Intradialytic Resistance Exercise on Alertness and Executive Function in Outpatients Undergoing Maintenance Hemodialysis
Scientific Title:Acronym
Randomized controlled trial
Region
| Japan |
Condition
Condition
chronic renal failure
Classification by specialty
| Cardiology | Rehabilitation medicine |
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
Frontal Assessment Battery (FAB) (90 days after the start of the resistance exercise intervention during dialysis)
Key secondary outcomes
The following measures at 90 days
(between-group comparison adjusted for
baseline values):
1. PVT median reaction time (key
secondary outcome)
2. MNA-SF score (key secondary
outcome)
Supplementary measures: Epworth
Sleepiness Scale (ESS), International
Physical Activity Questionnaire-Short
Form (IPAQ-S), serum albumin,
cholinesterase, NT-proBNP, and exercise
adherence rate in the exercise group
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Exercise group: In addition to usual
hemodialysis care, participants perform
intradialytic resistance exercise within the
first 2 hours of dialysis, 3 times per week
for approximately 20 minutes per session,
for 90 days. Target intensity is a Borg
rating of perceived exertion of 13
(somewhat hard).
At sites A and B, participants perform six
lower-limb and gluteal resistance
exercises using elastic bands of four
resistance levels; at sites C and D, they
perform body-weight resistance exercises
(lower limbs, gluteal, trunk) while
following a video displayed on the
bedside monitor. Load and repetitions are
individually set by a physical therapist on
the first day to achieve moderate
intensity, with supervision by a physical
therapist as needed.
Interventions/Control_2
Control group: Participants continue usual
hemodialysis care for 90 days without any
study exercise program (no intradialytic
exercise is provided as usual care at any
participating site).
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
The study included 70 outpatients undergoing maintenance dialysis who provided informed, voluntary written consent. Inclusion criteria were: being an outpatient on maintenance dialysis capable of walking, and having no motor impairment in the limb not used for the vascular access (non-shunt limb).
Key exclusion criteria
Exclusion criteria included severe dementia or other conditions that would make it difficult for the patient to understand verbal instructions or written descriptions of the exercise regimen.
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
70
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study included 70 participants (35 in the exercise intervention group and 35 in the control group). The mean age was 76.44 +- 7.91 years; 42 participants (60.0%) were male, 29 (41.4%) had diabetes as the primary underlying disease, and the median duration of dialysis was 101 months. Baseline (pre-intervention) values were as follows: FAB score, 13.31 +- 2.43; PVT median reaction time, 419 ms; and MNA-SF score, 11. There were no significant differences between the groups regarding baseline characteristics or pre-intervention assessment scores.
Participant flow
Of 99 patients analyzed in the preceding
cross-sectional study, 29 were excluded
because they declined to participate or
could not provide consent due to
hospitalization or complications. The
remaining 70 patients provided written
consent, completed baseline assessment,
and were randomly allocated to the
exercise group (n = 35) or the control
group (n = 35) by stratified block
randomization by age (<80 / >=80 years).
All participants in both groups completed
the 90-day assessment with no dropouts
or missing data. All 70 participants were
analyzed according to their allocated
group.
Adverse events
No exercise-related
adverse events were observed during
the study period.
Outcome measures
Primary outcome: FAB
Key secondary outcomes: PVT median
reaction time, MNA-SF
Supplementary measures: ESS, IPAQ-S,
serum albumin, cholinesterase, NT-
proBNP, exercise adherence rate
Plan to share IPD
No
IPD sharing Plan description
There is no plan to share individual
participant data.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2025 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2026 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2026 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2026 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 08 | Month | 05 | Day |
Last modified on
| 2026 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067106
