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 | 2026/05/08 11:21:16 |
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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
Alterations in lower limb muscle strength
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
Implementation of Hybrid Training Approach ( integrating voluntary exercise and electrical stimulation): Exercise Protocol A encompasses Hybrid Training followed by standard exercise regimens, with an intervening one-month washout period between the two interventions.
Interventions/Control_2
Exercise Protocol B standard exercise regimens, with an intervening one-month washout period between the two interventions.
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. Individuals aged 20 to 90 years receiving dialysis treatment at Toyota Memorial Hospital during the consent acquisition phase
2. Individuals demonstrating complete comprehension of the study protocols and voluntarily consenting to participate
Key exclusion criteria
1. Individuals with contraindications to electrical stimulation (including those with implanted electronic medical devices such as pacemakers, deep vein thrombosis, malignant tumors, or hemorrhagic lesions near electrode placement sites)
2. Patients in the acute phase of various diseases
3. Those with lower limb amputations
4. Non-ambulatory individuals
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
Kansai Medical University
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
No longer recruiting
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
| 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
| 2025 | Year | 01 | Month | 06 | Day |
Last modified on
| 2026 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064496
