UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029940 |
|---|---|
| Receipt number | R000034200 |
| Scientific Title | Effects of perioperative electrical muscle stimulation in elderly patients with diabetes after cardiovascular surgery -a multicenter, parallel group, randomized controlled trial- |
| Date of disclosure of the study information | 2017/12/01 |
| Last modified on | 2023/01/16 17:17:31 |
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Basic information
Public title
Effects of perioperative electrical muscle stimulation in elderly patients with diabetes after cardiovascular surgery
-a multicenter, parallel group, randomized controlled trial-
Acronym
Effects of perioperative electrical muscle stimulation in elderly patients with diabetes after cardiovascular surgery
-a multicenter, parallel group, randomized controlled trial-
Scientific Title
Effects of perioperative electrical muscle stimulation in elderly patients with diabetes after cardiovascular surgery
-a multicenter, parallel group, randomized controlled trial-
Scientific Title:Acronym
Effects of perioperative electrical muscle stimulation in elderly patients with diabetes after cardiovascular surgery
-a multicenter, parallel group, randomized controlled trial-
Region
| Japan |
Condition
Condition
Elderly patients with diabetes who are intending for elective cardiovascular surgery
Classification by specialty
| Cardiovascular surgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of perioperative electrical muscle stimulation on decreasing physical function after cardiovascular surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Isometric knee extensor strength (Preoperative, Postoperative day 7)
Sub group analysis
Analysis of primary outcomes for stratification in patients with dialysis, diabetes neuropathy, frail, progress of NMES and management diabetes (postoperative hyperglycemia, amount of medication, hemoglobin A1c)
Key secondary outcomes
Comfortable walking speed (Preoperative, Postoperative day 7)
Maximum walking speed(Preoperative, Postoperative day 7)
Grip Strength(Preoperative, Postoperative day 7)
Self Efficacy of Walking (Preoperative, Postoperative day 7)
Sub group analysis
Analysis of secondary outcomes for stratification in patients with dialysis, diabetes neuropathy, frail, progress of NMES and management diabetes (postoperative hyperglycemia, amount of medication, hemoglobin A1c)
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
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Post-operative electrical muscle stimulation and ambulation program.
Electrical muscle stimulation: implemented on the bilateral quadriceps and triceps surae muscle for 60 minutes per day. 5 times per week after surgery . Amplitude set to elicit visible contraction to maximum tolerated intensity
Interventions/Control_2
Sham stimulation by micro current stimulation and ambulation program.
Sham stimulation: implemented on the bilateral quadriceps and triceps surae muscle for 60 minutes per day. 5 times per week after surgery.
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. Over 65 years-old
2. Patients with diabetes who are intended for elective cardiovascular surgery.
Key exclusion criteria
1. Patients with dimentia (MMSE <18)
2. Patients who can not walk independently
3. Patients who are using assisted circulation apparatus for more than 48 hours after surgery
4. Patients who the state of discontinuation criteria for neuroelectric stimulation therapy continues more than 48 hours after surgery
5. Development of central nervous system disease after surgery
6. Reoperation after surgery
7. Patients who can not stand up until 7th days after surgery
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Sumio |
| Middle name | |
| Last name | Yamada |
Organization
Nagoya University Graduate School
Division name
Medicine
Zip code
4618673
Address
1-1-20 Daiko-Minami, Higashi-ku, Nagoya City
TEL
0527191504
yamadas@met.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Kouya |
| Middle name | |
| Last name | Takino |
Organization
Gifu Heart Center
Division name
Cardiac rehabilitation
Zip code
5008384
Address
4-14-4, Yabuta-Minami, Gifu City
TEL
0582772277
Homepage URL
shinriha@heart-center.or.jp
Sponsor or person
Institute
Gifu Heart Center
Institute
Department
Personal name
Funding Source
Organization
none
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
Gifu heart center
Address
4-14-4, Yabuta-Minami, Gifu City
Tel
0582772277
shinriha@heart-center.or.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
| 2017 | Year | 12 | 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
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
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 12 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 02 | 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
| 2017 | Year | 11 | Month | 12 | Day |
Last modified on
| 2023 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034200
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
