UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011165 |
|---|---|
| Receipt number | R000013077 |
| Scientific Title | Effects of Postoperative Electrical Muscle Stimulation on Functional Decline in Patients after Cardiovascular Surgery - Multicentre Randomized Controlled Trial - |
| Date of disclosure of the study information | 2013/07/10 |
| Last modified on | 2023/01/31 10:12:10 |
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Basic information
Public title
Effects of Postoperative Electrical Muscle Stimulation on Functional Decline in Patients after Cardiovascular Surgery - Multicentre Randomized Controlled Trial -
Acronym
Effects of Postoperative Electrical Muscle Stimulation on Functional Decline in Patients after Cardiovascular Surgery - Multicentre Randomized Controlled Trial -
Scientific Title
Effects of Postoperative Electrical Muscle Stimulation on Functional Decline in Patients after Cardiovascular Surgery - Multicentre Randomized Controlled Trial -
Scientific Title:Acronym
Effects of Postoperative Electrical Muscle Stimulation on Functional Decline in Patients after Cardiovascular Surgery - Multicentre Randomized Controlled Trial -
Region
| Japan |
Condition
Condition
Adult patients who are intended for elective cardiovascular surgery
Classification by specialty
| Cardiovascular surgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the preventive effect of postoperative electrical muscle stimulation on functional decline after cardiovascular surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Isometric knee extensor muscle strength, 6 minutes walking distance
Key secondary outcomes
Grip strength, 10 meter normal walking time, Thigh circumference, Calf circumference, Self-Efficacy of Physical Activity, Hospital Anxiety and Depression Scale, Performance Measure for Activities of Daily Living-8, Participation-6, Physical activity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Electrical muscle stimulation and ambulation program
Electrical muscle stimulation: implemented on the bilateral quadriceps and triceps surae muscles for 30-60 minutes per day, 5 days per week, and 2 weeks after surgery
Interventions/Control_2
Ambulation program
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 18 years old
2. Patients who are intended for elective cardiovascular surgery
Key exclusion criteria
1.Patients with peripheral arterial disease
2.Patients with cognitive impairment before surgery (MMSE<23)
3.Patients with a previous history of psychiatric disorder
4.Patients with a previous history of neuromuscular disease
5.Patients who are not allowed to receive electrical muscle stimulation by primary doctor
Target sample size
166
Research contact person
Name of lead principal investigator
| 1st name | Sumio |
| Middle name | |
| Last name | Yamada |
Organization
Nagoya University
Division name
Graduate School of Medicine
Zip code
461-8673
Address
Daikominami 1-1-20 Higashi-ku Nagoya
TEL
052-719-1346
yamadas@met.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Sumio |
| Middle name | |
| Last name | Yamada |
Organization
Nagoya University
Division name
Graduate School of Medicine
Zip code
461-8673
Address
Daikominami 1-1-20 Higashi-ku Nagoya
TEL
052-719-1346
Homepage URL
yamadas@met.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
MINATO MEDICAL SCIENCE CO.,LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Nagoya University Graduate School of Medicine
Address
65 Tsurumai-cho, Showa-ku, Nagoya
Tel
052-744-2061
ethics@med.nagoya-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
| 2013 | Year | 07 | Month | 10 | Day |
Related information
URL releasing protocol
https
Publication of results
Unpublished
Result
URL related to results and publications
https
Number of participants that the trial has enrolled
166
Results
This study stopped because data needed for the analysis was not fully obtained.
Results date posted
| 2023 | Year | 01 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Mean age: Intervention 67.8(SD 11.3) yo, Control 69.7(SD 10.5) yo
Men: Intervention n=55, Control n=50
BMI: Intervention 23.4 (SD 3.8) kg/m2, Control 23.2 (SD) 3.2 kg/m2
Participant flow
A total of 166 patients were recruited. Eleven patients and 9 patients dropped out from the intervention group and control group, respectively.
Of those assigned to the intervention group, 20 patients did not receive enough volume of intervention (NMES).
Adverse events
Not observed.
Outcome measures
This study stopped because data needed for the analysis was not fully obtained.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2013 | Year | 11 | Month | 27 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 15 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 10 | Day |
Last modified on
| 2023 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013077
