UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057370 |
|---|---|
| Receipt number | R000065559 |
| Scientific Title | The effect of preoperative neuromuscular electrical stimulation on muscle quality and clinical outcomes in patients undergoing cardiovascular surgery: a randomized controlled trial |
| Date of disclosure of the study information | 2025/03/30 |
| Last modified on | 2025/03/24 08:40:33 |
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Basic information
Public title
The effect of preoperative neuromuscular electrical stimulation on muscle quality and clinical outcomes in patients undergoing cardiovascular surgery: a randomized controlled trial
Acronym
Preoperative neuromuscular electrical stimulation in patients undergoing cardiovascular surgery
Scientific Title
The effect of preoperative neuromuscular electrical stimulation on muscle quality and clinical outcomes in patients undergoing cardiovascular surgery: a randomized controlled trial
Scientific Title:Acronym
Preoperative neuromuscular electrical stimulation in patients undergoing cardiovascular surgery
Region
| Japan |
Condition
Condition
Patients undergoing cardiovascular surgery
Classification by specialty
| Cardiovascular surgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of neuromuscular electrical stimulation on muscle quality and clinical outcomes in patients undergoing cardiovascular surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle quality
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The treatment group will receive 40 minutes of daily neuromuscular electrical stimulation to the lower limbs for at least two weeks until surgery.
Interventions/Control_2
The control group will receive exercise guidance using a pamphlet.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients aged 65 years or older who underwent preoperative CT evaluation.
2. Patients with a period of at least two weeks between surgery decision and surgery.
3. Patients who received a verbal explanation using an information document and provided written informed consent.
Key exclusion criteria
1. Patients with limb amputation
2. Patients with a pacemaker or Implantable Cardioverter Defibrillator (ICD) implantation
3. Patients with severe sensory impairment
4. Patients with hemiplegia
5. Patients with untreated bleeding at the site of electrical stimulation
6. Patients with unstable angina
7. Patients with uncontrolled arrhythmia
8. Patients with hemodynamic instability
9. Patients with inability to walk independently
10.Patients who failed to provide consent following explanation of the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Matsuzawa |
Organization
Hyogo Medical University
Division name
Department of Physical Therapy School of Rehabilitation
Zip code
650-8530
Address
1-3-6 Minatojima, Chuo-ku, Kobe, Hyogo
TEL
078-304-3181
ri-matsuzawa@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Matsuzawa |
Organization
Hyogo Medical University
Division name
Department of Physical Therapy School of Rehabilitation
Zip code
650-8530
Address
1-3-6 Minatojima, Chuo-ku, Kobe, Hyogo
TEL
078-304-3181
Homepage URL
ri-matsuzawa@hyo-med.ac.jp
Sponsor or person
Institute
Department of Physical Therapy School of Rehabilitation, Hyogo Medical University, Kobe, Hyogo, Japan
Institute
Department
Personal name
Funding Source
Organization
Department of Physical Therapy School of Rehabilitation, Hyogo Medical University, Kobe, Hyogo, Japan
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
The Ethics Review Board of Hyogo Medical University
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, 663-8501
Tel
0798-45-6066
rinri@hyo-med.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
| 2025 | Year | 03 | Month | 30 | 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
| 2025 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 10 | Month | 01 | 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 | 03 | Month | 24 | Day |
Last modified on
| 2025 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065559
