UMIN-ICDS Clinical Trial

Public title

A Study of the Effects of Electrical Muscle Stimulation on Leg Venous Blood Flow During Upright Positioning in Critically Ill Patients

Acronym

eMVP-ICU Study

Scientific Title

Effects of Combined Electrical Muscle Stimulation and Cardiac Chair Positioning on Femoral Venous Blood Flow in Critically Ill Patients: A Randomized Crossover Pilot Trial

Scientific Title:Acronym

eMVP-ICU Trial

Region

Japan

Condition

Critically ill adult patients admitted to an intensive care unit who are unable to undergo early mobilization

Classification by specialty

Emergency medicine	Intensive care medicine	Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the effect of adding electrical muscle stimulation to cardiac chair positioning on the change in common femoral vein blood flow from 15 minutes of supine rest to 3 minutes after cardiac chair positioning, compared with cardiac chair positioning alone, in critically ill adult patients who are unable to undergo early mobilization in the intensive care unit. The study will also explore the associations of baseline thigh muscle mass and changes in blood pressure with changes in common femoral vein blood flow, and will estimate effect sizes and variability for a future confirmatory trial.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Change in common femoral vein blood flow from 15 minutes of supine rest to 3 minutes after cardiac chair positioning (Flow, mL/min).
Change in Flow is calculated as common femoral vein blood flow at 3 minutes after cardiac chair positioning minus common femoral vein blood flow after 15 minutes of supine rest. Change in Flow will be compared between the electrical muscle stimulation plus cardiac chair positioning condition and the cardiac chair positioning-alone condition.

Key secondary outcomes

1. Associations of rectus femoris cross-sectional area and combined rectus femoris and vastus intermedius muscle thickness, measured by ultrasound at baseline, with changes in common femoral vein blood flow under each intervention condition.
2. Associations of changes in systolic, diastolic, and mean arterial blood pressure from 15 minutes of supine rest to 3 minutes after cardiac chair positioning with changes in common femoral vein blood flow.

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Maneuver

Interventions/Control_1

AB sequence. Electrical muscle stimulation plus cardiac chair positioning followed by a washout period and then cardiac chair positioning alone.

Treatment A. After 15 minutes of supine rest, electrical muscle stimulation will be initiated using a belt electrode skeletal muscle electrical stimulation device called G TES. Stimulation will be delivered continuously at a frequency of 4 Hz and a pulse width of 250 microseconds. The stimulation intensity will be adjusted to produce visible muscle contractions. After 10 minutes of stimulation in the supine position, cardiac chair positioning will be applied while electrical muscle stimulation is continued. Cardiac chair positioning will consist of 30 degrees of head of bed elevation combined with 12 degrees of whole bed tilt. Common femoral vein blood flow and blood pressure will be measured 3 minutes after positioning.

A washout period will be provided after Treatment A. Treatment B will be initiated after blood pressure has returned to the baseline value measured after 15 minutes of supine rest.

Treatment B. After 15 minutes of supine rest, cardiac chair positioning consisting of 30 degrees of head of bed elevation combined with 12 degrees of whole bed tilt will be applied without electrical muscle stimulation. Common femoral vein blood flow and blood pressure will be measured 3 minutes after positioning. Both treatments will be conducted on the same day.

Interventions/Control_2

BA sequence. Cardiac chair positioning alone followed by a washout period and then electrical muscle stimulation plus cardiac chair positioning.

Treatment B. After 15 minutes of supine rest, cardiac chair positioning consisting of 30 degrees of head of bed elevation combined with 12 degrees of whole bed tilt will be applied without electrical muscle stimulation. Common femoral vein blood flow and blood pressure will be measured 3 minutes after positioning.

A washout period will be provided after Treatment B. Treatment A will be initiated after blood pressure has returned to the baseline value measured after 15 minutes of supine rest.

Treatment A. After 15 minutes of supine rest, electrical muscle stimulation will be initiated using a belt electrode skeletal muscle electrical stimulation device called G TES. Stimulation will be delivered continuously at a frequency of 4 Hz and a pulse width of 250 microseconds. The stimulation intensity will be adjusted to produce visible muscle contractions. After 10 minutes of stimulation in the supine position, cardiac chair positioning will be applied while electrical muscle stimulation is continued. Cardiac chair positioning will consist of 30 degrees of head of bed elevation combined with 12 degrees of whole bed tilt. Common femoral vein blood flow and blood pressure will be measured 3 minutes after positioning. Both treatments will be conducted on the same day.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Adult patients aged 18 years or older who are admitted to the intensive care unit at Hitachi General Hospital.
2. Patients primarily managed by the Department of Emergency and Critical Care Medicine.
3. Patients referred for rehabilitation by the Department of Emergency and Critical Care Medicine.
4. Patients who are unable to undergo early mobilization and have an ICU Mobility Scale score of less than 3.
5. Patients for whom written informed consent is obtained from the patient or a legally authorized representative.

Key exclusion criteria

1. Patients capable of early mobilization, defined as an ICU Mobility Scale score of 3 or higher.
2. Patients receiving extracorporeal membrane oxygenation, IMPELLA support, or intra-aortic balloon pumping.
3. Patients with a contraindication to electrical muscle stimulation, including an implanted cardiac pacemaker or skin lesions at the electrode application sites.
4. Patients with active deep vein thrombosis in a lower limb.
5. Patients receiving neuromuscular blocking agents.
6. Patients who decline participation or for whom written informed consent cannot be obtained from the patient or a legally authorized representative.

Target sample size

30

Name of lead principal investigator

1st name	Takahiro
Middle name
Last name	Fujita

Organization

Hitachi General Hospital

Division name

Department of Rehabilitation

Zip code

3170077

Address

2-1-1 Jonancho, Hitachi, Ibaraki 317-0077, Japan

TEL

0294-23-1111

Email

arigato.jan.3rd.1439@gmail.com

Name of contact person

1st name	Takahiro
Middle name
Last name	Fujita

Organization

Hitachi General Hospital

Division name

Department of Rehabilitation

Zip code

317-0077

Address

2-1-1 Jonancho, Hitachi, Ibaraki 317-0077, Japan

TEL

0294-23-1111

Homepage URL

Email

arigato.jan.3rd.1439@gmail.com

Institute

Hitachi General Hospital

Institute

Department

Personal name

Organization

Hitachi General Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Graduate School of Health Science, Juntendo University

Name of secondary funder(s)

Organization

Research Ethics Review Committee, Hitachi General Hospital

Address

2-1-1 Jonancho, Hitachi, Ibaraki 317-0077, Japan

Tel

0294-23-1111

Email

arigato.jan.3rd.1439@gmail.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

株式会社日立製作所 日立総合病院（茨城県）

Date of disclosure of the study information

2026

Year

08

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

14

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

Recruitment status

Completed

Date of protocol fixation

2026

Year

02

Month

20

Day

Date of IRB

2026

Year

02

Month

20

Day

Anticipated trial start date

2026

Year

02

Month

23

Day

Last follow-up date

2026

Year

07

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

08

Month

20

Day

Last modified on

2026

Year

08

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071671