UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060955 |
|---|---|
| Receipt number | R000064301 |
| Scientific Title | Effects of exercise intervention on immune function and physical performance in long term intermittent hemodialysis patients -pilot study- |
| Date of disclosure of the study information | 2026/03/20 |
| Last modified on | 2026/03/17 06:45:35 |
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Basic information
Public title
Effects of exercise intervention on immune function and physical performance in long term intermittent hemodialysis patients -pilot study-
Acronym
Effects of exercise intervention on immune function and physical performance in long term intermittent hemodialysis patients -pilot study-
Scientific Title
Effects of exercise intervention on immune function and physical performance in long term intermittent hemodialysis patients -pilot study-
Scientific Title:Acronym
Effects of exercise intervention on immune function and physical performance in long term intermittent hemodialysis patients -pilot study-
Region
| Japan |
Condition
Condition
chronic kidney disease reated by dialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
There is insufficient information on exercise intervention studies in long-term hemodialysis patients. Therefore, we aimed to clarify the effects of exercise therapy on cellular immunity, humoral immunity, nutritional status, and motor function in long-term hemodialysis patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in peripheral blood natural killer (NK) cell activity before and after a 90-day intervention in outpatient maintenance hemodialysis patients undergoing hemodialysis three times per week (6 hours per session), who performed approximately 30 minutes of intradialytic exercise consisting of resistance training and aerobic exercise using a cycle ergometer during each dialysis session.
Key secondary outcomes
Outpatient maintenance hemodialysis patients undergoing hemodialysis three times per week (6 hours per session) were enrolled. During each dialysis session, participants performed approximately 30 minutes of intradialytic exercise consisting of resistance training and aerobic exercise using a cycle ergometer.
Immunological assessments conducted before the intervention and after 90 days included granulocyte activity, immunoglobulin levels, and natural killer (NK) cell activation receptors. Physical function was evaluated using the Short Physical Performance Battery (SPPB) and the Timed Up and Go test (TUG). Nutritional status was assessed using the Geriatric Nutritional Risk Index (GNRI) and the Nutritional Risk Index for Japanese Hemodialysis Patients (NRI-JH). Quality of life (QOL) was evaluated using the EQ-5D-5L.
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Outpatient maintenance dialysis patients undergoing 6-hour dialysis three times a week underwent resistance exercise and aerobic exercise using an ergometer for a total of approximately 30 minutes during dialysis for 90 days.
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
Patients who have provided written informed consent to participate in this study.
Sex: no restriction (both male and female patients are eligible).
Age: 20 years or older at the time of consent.
Treatment setting: outpatient.
Patients undergoing maintenance hemodialysis for at least 6 months since initiation of dialysis, with a dialysis duration of 6 hours or longer per session.
Key exclusion criteria
Patients who are considered to have contraindications to exercise therapy based on a cardiac exercise stress test.
Patients with a history of hospitalization within the past 3 months.
Patients who are judged by the attending physician to be inappropriate for participation in this study for any other reason.
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | hirayasu |
| Middle name | |
| Last name | kai |
Organization
Ibaraki Prefectural Central Hospital
Division name
Nephrology
Zip code
309-1703
Address
6528 Koibuchi, Kasama City, Ibaraki Prefecture
TEL
0296-77-1121
himawari.park21217@gmail.com
Public contact
Name of contact person
| 1st name | Akihisa |
| Middle name | |
| Last name | Hattori |
Organization
Ibaraki Prefectural Central Hospital
Division name
Nephrology
Zip code
309-1703
Address
6528 Koibuchi, Kasama City, Ibaraki Prefecture
TEL
0296-77-1121
Homepage URL
himawari.park21217@gmail.com
Sponsor or person
Institute
Ibaraki Prefectural Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Ibaraki Prefectural Central Hospital
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
Ibaraki Prefectural Central Hospital
Address
6528 Koibuchi, Kasama City, Ibaraki Prefecture
Tel
0296-77-1121
himawari.park21217@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 | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
9
Results
Regarding the primary outcome, natural killer cell activity did not show a statistically significant difference after the intervention (p = 0.23).
Results date posted
| 2026 | Year | 02 | Month | 26 | 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
| 2024 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2026 | 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 | 03 | Month | 17 | Day |
Last modified on
| 2026 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000064301
