UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062958 |
|---|---|
| Receipt number | R000072082 |
| Scientific Title | Combined exercise and nutritional intervention in patients undergoing maintenance hemodialysis with cachexia: A pilot study |
| Date of disclosure of the study information | 2026/09/21 |
| Last modified on | 2026/09/17 13:01:17 |
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Basic information
Public title
Combined exercise and nutritional intervention in patients undergoing maintenance hemodialysis with cachexia: A pilot study
Acronym
Exercise and nutrition intervention in hemodialysis patients
Scientific Title
Combined exercise and nutritional intervention in patients undergoing maintenance hemodialysis with cachexia: A pilot study
Scientific Title:Acronym
Exercise and nutrition intervention in hemodialysis patients
Region
| Japan |
Condition
Condition
End-stage kidney disease on maintenance hemodialysis with cachexia
Classification by specialty
| Nephrology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To exploratively evaluate the effectiveness of a combined exercise and nutritional intervention for improving cachexia-related symptoms in patients with end-stage kidney disease undergoing maintenance hemodialysis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in handgrip strength from baseline to 3 months after initiation of the intervention
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
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Participants will receive a 3-month nutritional intervention using an oral nutritional supplement (ENEVO) to achieve a protein intake of 1.2 g/kg/day. In addition, aerobic exercise using an adjustable-load cycle ergometer will be performed during outpatient hemodialysis for 30 minutes per session, three times per week, for 3 months. Exercise intensity will be adjusted to approximately 13 on the Borg Rating of Perceived Exertion Scale.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients aged 18 years or older at the time of enrollment.
2. Patients with end-stage kidney disease undergoing outpatient maintenance hemodialysis who have cachexia.
3. Patients who have received sufficient explanation about the study and provided written informed consent.
Key exclusion criteria
1. Patients with physical or cognitive impairments that may interfere with the conduct of the study.
2. Patients with malignancies or medical conditions requiring active treatment.
3. Patients receiving steroid therapy.
4. Patients in poor general condition with an expected prognosis limited to several months.
5. Patients considered unsuitable for participation in the study by the attending physician.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Hideyuki |
| Middle name | |
| Last name | Oritsu |
Organization
Yokohama City University Hospital
Division name
Department of Rehabilitation
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa 236-0004, Japan
TEL
045-787-2800
oritsu@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Masatsugu |
| Middle name | |
| Last name | Okamura |
Organization
Yokohama City University
Division name
Department of Rehabilitation Medicine, School of Medicine
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa 236-0004, Japan
TEL
045-787-2713
Homepage URL
okamura@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS)
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
Yokohama City University Ethics Committee
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa 236-0004, Japan
Tel
045-370-7627
rinri@yokohama-cu.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
| 2026 | Year | 09 | Month | 21 | 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 | 04 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | 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
| 2026 | Year | 09 | Month | 17 | Day |
Last modified on
| 2026 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072082
