UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039926 |
|---|---|
| Receipt number | R000045532 |
| Scientific Title | The effectiveness of electrical muscle stimulation in patients after open heart surgery |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2023/03/27 09:07:15 |
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Basic information
Public title
The effectiveness of electrical muscle stimulation in patients after open heart surgery
Acronym
The effectiveness of electrical muscle stimulation in patients after open heart surgery
Scientific Title
The effectiveness of electrical muscle stimulation in patients after open heart surgery
Scientific Title:Acronym
The effectiveness of electrical muscle stimulation in patients after open heart surgery
Region
| Japan |
Condition
Condition
Adult patients who are intending for elective open heart surgery
Classification by specialty
| Cardiology | Cardiovascular surgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of post-operative electrical muscle stimulation on early ambulation and hospital discharge after open heart surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Length of days to walk 100 m
Key secondary outcomes
Post-operative length of hospital stay
The rate of discharge at home
Muscle quantity
Grip strength
Knee extension strength
Gait speed
One leg standing time
Short physical performance battery (SPPB)
6-minutes walking distance
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Post-operative ambulation program and electrical muscle stimulation.
Electrical muscle stimulation: implemented on the bilateral quadriceps, hamstrings, triceps surae, tibial anterior muscles using belt electrode for 30 minutes per day during operation day to post operation day 6 (7 days).
Interventions/Control_2
Post-operative ambulation program and electrical muscle stimulation.
Electrical muscle stimulation: implemented on the bilateral quadriceps, hamstrings, triceps surae, tibial anterior muscles but intensity is not cause muscle contraction for 30 minutes per day during operation day to post operation day 6 (7 days).
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Over 20 years old
2. Patients undergo elective open heart surgery
Key exclusion criteria
1. Patients After pacemaker implantation
2. Patients with skin disorder
3. Patients after stroke with severe functional limitation
4. Patients who cannot walk before surgery
5. Patients with deep vein thrombus
6. Patients with severe cognitive impairment
7. Patients deemed ineligible by the attending physician
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Kiryu |
Organization
Akita University Graduate School of Medicine
Division name
Department of Cardiovascular Surgery
Zip code
010-8543
Address
1-1-1, Hondo, Akita
TEL
018-884-6134
k.kiryu83@gmail.com
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Kiryu |
Organization
Akita University Graduate School of Medicine
Division name
Department of Cardiovascular Surgery
Zip code
010-8543
Address
1-1-1, Hondo, Akita
TEL
018-884-6134
Homepage URL
k.kiryu83@gmail.com
Sponsor or person
Institute
Akita University
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Akita University Medical Ethic Committee
Address
1-1-1, Hondo, Akita
Tel
018-884-6028
soken@hos.akita-u.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
| 2020 | Year | 04 | Month | 01 | 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
0
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
Terminated
Date of protocol fixation
| 2019 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2020 | Year | 03 | Month | 24 | Day |
Last modified on
| 2023 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045532
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
