UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029940
Receipt No. 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 2019/07/24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email shinriha@heart-center.or.jp

Sponsor
Institute Gifu Heart Center
Institute
Department

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
Email 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 Open public recruiting
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
2019 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034200

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.