UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059616 |
|---|---|
| Receipt number | R000068177 |
| Scientific Title | Validation of muscle function assessment on dialysis and non-dialysis days in patients with kidney failure: an observational study |
| Date of disclosure of the study information | 2025/11/02 |
| Last modified on | 2025/11/01 23:29:28 |
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Basic information
Public title
Validation of muscle function assessment on dialysis and non-dialysis days in patients with renal failure
Acronym
Public title (short): Validation of muscle function tests on dialysis vs non-dialysis days
Scientific Title
Validation of muscle function assessment on dialysis and non-dialysis days in patients with kidney failure: an observational study
Scientific Title:Acronym
Dialysis-day Muscle Function Assessment validity study
Region
| Japan |
Condition
Condition
Hospitalized patients with chronic renal failure receiving maintenance dialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Patients on hemodialysis typically undergo 4 hours of treatment three times per week. Consequently, dialysis days entail substantial time constraints patients are confined to bed during treatment and often report fatigue afterward, leading to reduced activity levels. This in turn predisposes to declines in activities of daily living (ADL) and quality of life (QOL) through deterioration of systemic metabolic function. With advancing age and longer dialysis vintage, overall physical activity also tends to decrease.
It is well established among physiotherapists that exercise therapy for patients on dialysis can improve muscle strength, ADL, and QOL. However, clinical guidelines recommend low-intensity physiotherapy during the dialysis period, particularly on dialysis days, favoring conditioning or stretching. In practice, exercise therapy may be difficult to implement on dialysis days because patients frequently experience fatigue and difficulty generating force. Moreover, although systematic reviews have investigated the acute post-dialysis effects on lower-limb muscle function, consensus has not yet been reached.
Therefore, in this study we will examine differences in quadriceps force generation between dialysis and non-dialysis days and evaluate the effects of exercise therapy, with the aim of clarifying dialysis-related differences in muscle function.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Pre- and post-intervention fatigue (modified Borg scale)
2.Pre- and post-intervention surface EMG of the vastus medialis during seated knee extension
3.Pre- and post-intervention lower-limb muscle strength (quadriceps) during seated knee extension, measured with a handheld dynamometer
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
On two consecutive days-one dialysis day (post-dialysis) and one non-dialysis day-fatigue at the same time of day will be assessed using a visual analogue scale (VAS) interview.
Subsequently, isometric knee-extension strength will be measured five times with a handheld dynamometer.
During these measurements, surface electromyography (sEMG) of the vastus medialis will be recorded simultaneously.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with renal failure who were hospitalized at our institution and received dialysis between April 2023 and April 2026, and who meet all of the following inclusion criteria
1.A prescription for physical therapy issued by a rehabilitation physician.
2.Ability to understand the instructions.
3.No implanted pacemaker and no metallic implants in the thigh.
4.Age over 18 years.
Key exclusion criteria
Patients in whom evaluation devices cannot be used because of infectious diseases or similar conditions.
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Kurita |
| Middle name | |
| Last name | Shinya |
Organization
Tokyo Metropolitan Hospital Organization Tokyo Metropolitan Okubo Hospital
Division name
Department of Rehabilitation Medicine
Zip code
160-8488
Address
2-44-1 Kabukicho, Shinjuku-ku, Tokyo, Japan
TEL
0352858811
shinya_kurita@tmhp.jp
Public contact
Name of contact person
| 1st name | Kurita |
| Middle name | |
| Last name | Shinya |
Organization
Tokyo Metropolitan Hospital Organization Tokyo Metropolitan Okubo Hospital
Division name
Department of Rehabilitation Medicine
Zip code
160-8488
Address
2-44-1 Kabukicho, Shinjuku-ku, Tokyo, Japan
TEL
0352858811
Homepage URL
shinya_kurita@tmhp.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
Other
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
Tokyo Metropolitan Hospital Organization Tokyo Metropolitan Okubo Hospital
Address
2-44-1 Kabukicho, Shinjuku-ku, Tokyo, Japan
Tel
0352858811
shinya_kurita@tmhp.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 | 11 | Month | 02 | 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
45
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
Completed
Date of protocol fixation
| 2023 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | 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 | 11 | Month | 01 | Day |
Last modified on
| 2025 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068177
