UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056643 |
|---|---|
| Receipt number | R000064496 |
| Scientific Title | Evaluation of the Efficacy of Hybrid Training Incorporating Electrical Stimulation for Lower Limb Rehabilitation in Patients Undergoing Hemodialysis |
| Date of disclosure of the study information | 2025/01/07 |
| Last modified on | 2026/07/11 16:36:00 |
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Basic information
Public title
Efficacy of Combined Exercise Therapy and Electrical Stimulation for Lower Limb Rehabilitation in Hemodialysis Recipients
Acronym
Assessing the Impact of Hybrid Training on Physical Capabilities of Individuals Receiving Hemodialysis
Scientific Title
Evaluation of the Efficacy of Hybrid Training Incorporating Electrical Stimulation for Lower Limb Rehabilitation in Patients Undergoing Hemodialysis
Scientific Title:Acronym
Hybrid Training Study for Hemodialysis Patients (HT-HDP)
Region
| Japan |
Condition
Condition
Chronic Kidney Disease
Classification by specialty
| Nephrology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to investigate the effects of a novel Hybrid Training protocol that integrates voluntary exercise with simultaneous electrical stimulation on the physical performance of patients receiving hemodialysis treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in isometric knee extension force (KEF, Nm) from the period-specific baseline (Month 0) to Month 3
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Sequence A (usual exercise followed by hybrid training): Participants received 3 months of usual exercise, followed by a 1-month washout period and then 3 months of hybrid training. Usual exercise consisted of intradialytic supine cycling, whereas hybrid training consisted of the same cycling protocol combined with neuromuscular electrical stimulation.
Interventions/Control_2
Sequence B (hybrid training followed by usual exercise): Participants received 3 months of hybrid training, followed by a 1-month washout period and then 3 months of usual exercise. Hybrid training consisted of intradialytic supine cycling combined with neuromuscular electrical stimulation, whereas usual exercise consisted of intradialytic supine cycling alone.
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Adults who had been receiving maintenance hemodialysis for at least 3 months
2.Patients receiving maintenance hemodialysis three times weekly, with each session lasting 4 hours
3.Patients who received an adequate explanation of the study and voluntarily provided informed consent to participate
Key exclusion criteria
1.Individuals requiring assistance with activities of daily living
2.Individuals with unstable cardiovascular disease
3.Individuals with severe orthopedic disorders limiting exercise
4.Individuals with an implanted pacemaker or other contraindications to electrical stimulation
5.Individuals with severe skin hypersensitivity or dermatologic conditions affecting electrode placement
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Kengo |
| Middle name | |
| Last name | Taketani |
Organization
Toyota Memorial Hospital
Division name
Department of Rehabilitation
Zip code
4718513
Address
1-1,Hewiwa-cho,Toyota,Aichi
TEL
0565-28-0100
kengo_taketani@mail.toyota.co.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Kuwahara |
Organization
Toyota Memorial Hospital
Division name
Clinical Research Department
Zip code
4718513
Address
1-1,Hewiwa-cho,Toyota,Aichi
TEL
0565-28-0100
Homepage URL
keiko_kuwahara@mail.toyota.co.jp
Sponsor or person
Institute
Toyota Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Toyota Memorial Hospital Clinical Research Review Committee
Address
1-1,Hewiwa-cho,Toyota,Aichi
Tel
0565-28-0100
ya-kenkyu@mail.toyota.co.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 | 01 | 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
8
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
Deidentified individual participant data, including data dictionaries, will not be shared. No related documents will be made available.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | 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 | 01 | Month | 06 | Day |
Last modified on
| 2026 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064496
