UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000063044 |
|---|---|
| Receipt number | R000072165 |
| Scientific Title | Pengaruh Edukasi Fluid-Rest Balance terhadap Penurunan Interdialytic Weight Gain dan Restless Legs Syndrome pada Pasien Hemodialisis |
| Date of disclosure of the study information | 2026/09/24 |
| Last modified on | 2026/09/24 18:28:12 |
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Basic information
Public title
Fluid-Rest Balance Education for Interdialytic Weight Gain and Restless Legs Syndrome in Hemodialysis Patients
Acronym
Fluid-Rest Balance Education in Hemodialysis Patients
Scientific Title
Pengaruh Edukasi Fluid-Rest Balance terhadap Penurunan Interdialytic Weight Gain dan Restless Legs Syndrome pada Pasien Hemodialisis
Scientific Title:Acronym
Pengaruh Edukasi Fluid-Rest Balance terhadap Penurunan Interdialytic Weight Gain dan Restless Legs Syndrome pada Pasien Hemodialisis (Fluid-Rest Balance Education)
Region
| Asia(except Japan) |
Condition
Condition
Chronic Kidney Disease undergoing Hemodialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the effect of Fluid-Rest Balance education on the reduction of interdialytic weight gain and restless legs syndrome in hemodialysis patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in interdialytic weight gain (IDWG), measured in kilograms (kg) using pre- and post-hemodialysis body weight records. IDWG will be assessed at baseline before the first scheduled hemodialysis treatment and at post-intervention before the sixth scheduled hemodialysis treatment, following completion of four structured Fluid-Rest Balance education sessions delivered during the second to fifth scheduled hemodialysis treatments.
Key secondary outcomes
Change in the severity of Restless Legs Syndrome (RLS), measured using the International Restless Legs Syndrome Study Group Rating Scale (IRLS). RLS severity will be assessed at baseline before the first scheduled hemodialysis treatment and at post-intervention during the sixth scheduled hemodialysis treatment, following completion of four structured Fluid-Rest Balance education sessions delivered during the second to fifth scheduled hemodialysis treatments.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Fluid-Rest Balance education consists of four structured educational sessions, each lasting 15-20 minutes, delivered during the second to fifth scheduled hemodialysis treatments.
Interventions/Control_2
Fluid-Rest Balance booklet without structured educational sessions.
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients undergoing hemodialysis aged 18-60 years.
2. Undergoing hemodialysis for at least 3 months, with a frequency of 2-3 sessions per week.
3. No cognitive impairment based on the Mini-Mental State Examination (MMSE).
4. Experiencing Restless Legs Syndrome (RLS) symptoms based on clinical criteria of the International Restless Legs Syndrome Study Group (IRLSSG).
5. Having pre- and post-hemodialysis body weight records for at least the previous 2-4 weeks.
Key exclusion criteria
1. Participants who refuse to continue participation in the study.
2. Change of hemodialysis therapy to another renal replacement therapy, such as kidney transplantation or peritoneal dialysis.
3. Severe neurological disorders, including severe peripheral neuropathy, Parkinson's disease, or stroke.
4. Decreased level of consciousness or clinically unstable condition.
5. Comorbid conditions that may affect body fluid status, including a history of heart failure, diabetes mellitus, pulmonary edema, or pleural effusion.
6. Major changes in dopaminergic or antidepressant medication regimen within the previous 2-4 weeks.
Target sample size
96
Research contact person
Name of lead principal investigator
| 1st name | Maya |
| Middle name | Masita |
| Last name | Ratri |
Organization
Institut Teknologi dan Kesehatan Muhammadiyah Kalimantan Barat
Division name
Master of Nursing Program
Zip code
78391
Address
Jl. Sungai Raya Dalam Gg. Ceria V Nomor 2, Kubu Raya, Kalimantan Barat
TEL
085828386252
mayamasitaratri@gmail.com
Public contact
Name of contact person
| 1st name | Maya |
| Middle name | Masita |
| Last name | Ratri |
Organization
Institut Teknologi dan Kesehatan Muhammadiyah Kalimantan Barat
Division name
Master of Nursing Program
Zip code
78391
Address
Jl. Sungai Raya Dalam Gg. Ceria V Nomor 2, Kubu Raya, Kalimantan Barat
TEL
085828386252
Homepage URL
mayamasitaratri@gmail.com
Sponsor or person
Institute
Institut Teknologi dan Kesehatan Muhammadiyah Kalimantan Barat
Institute
Department
Personal name
Funding Source
Organization
Institut Teknologi dan Kesehatan Muhammadiyah Kalimantan Barat
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Komite Etik Penelitian Kesehatan RSUD Dr. Soedarso
Address
Jl. Dr. Soedarso No. 1, Pontianak, Kalimantan Barat
Tel
0561737701
kepk.rsuddrsoedarso@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
RSUD dr. Soedarso (Pontianak)
RSU YARSI Pontianak (Pontianak)
Rumah Sakit Tk. II Kartika Husada (Kubu Raya)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 24 | 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
No
IPD sharing Plan description
No plan to share individual participant data.
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 26 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | 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 | 24 | Day |
Last modified on
| 2026 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072165
