UMIN-CTR Clinical Trial

Public title

Effect of electrical muscle stimulation-induced passive leg cycle ergometer training on ventilated intensive care unit patients.

Acronym

Effect of hybrid EMS on ventilated ICU patients.

Scientific Title

Effect of electrical muscle stimulation-induced passive leg cycle ergometer training on ventilated intensive care unit patients.

Scientific Title:Acronym

Effect of hybrid EMS on ventilated ICU patients.

Region

Japan

Condition

Inclusion criteria were ICU patients who had been ventilated for more 2 days.

Classification by specialty

Intensive care medicine

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of this study will be to identify the effect of electrical muscle stimulation-induced passive leg cycle ergometer training (H-EMS) in ventilated intensive care unit (ICU) patients.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Primary outcomes were a change in the muscle cross-sectional area and muscle thickness from baseline to after 2 weeks, as measured using real-time B-mode ultrasonography with a 50mm 8MHz linear probe. During the ultrasonography, the participants were in a supine position with their knees extended at 0 degree and muscles relaxed. Four ultrasonography images were recorded at 50% on the line from the anterior superior iliac spine to the upper region of the patella of rectus femoris, vastus lateralis and vastus intermedius, and at 80% on the line between the anterior superior iliac spine and the joint space in front of the anterior border of the medial ligament of vastus medialis. Muscle thickness was calculated as the length between the deep aponeurosis and surface aponeurosis at 3 different points in the image. The mean thickness was calculated in each ultrasonography image.

Key secondary outcomes

Secondary outcomes included changes in physical function from day 2 after admission to the ICU and after being on a ventilator for more 2 days, to after 2 weeks as well as the health care cost and, health-related quality of life.
Interval-scored physical function ICU test (PFIT-s)
The medical research council (MRC) sum score
Quadriceps muscle strength: Isometric muscle strength of the quadriceps muscle was measured at the time of discharge from the hospital using a hand-held dynamometer . Patients sat with their hips and kneespositioned at 90 degree of flexion, and their arms folded across their chests. A sensor of the hand held dynamometer was attached to the lateral malleolus axis at the front of the lower leg. We instructed the patients to contract the quadriceps muscle "as hard and fast as possible" during the isometric quadriceps muscle contraction test. The test was repeated twice and a maximum knee extensor contraction of 5 seconds was performed with 2 minutes of rest between each test. The largest maximal volitional isometric knee extensor strength data was recorded as the absolute value.
Grip strength: Grip strength was measured on day 2 after admission to the ICU and after 2 weeks using a hand-held dynamometer. Patients lay with their elbow positioned at 90 degree of flexion. The test was repeated twice, and a maximum grip contraction of 3 seconds was performed with 2 minutes of rest between each test.
Intensive care delirium screening checklist
Confusion assessment method for the ICU
Length of bed rest
36 item short-form health survey

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

YES

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

ICU patients received traditional physical therapy and Hybrid EMS, which began within 48 hours of admission and continued daily for 2 weeks until discharge from ICU. The Hybrid EMS intervention involved an automatic cycle ergometer attached to a belt electrode skeletal muscle stimulator (Homer Ion Co. Ltd, Tokyo, Japan). The automatic cycle ergometer (Escargot, PBE100) was set at 40 to 50 revolutions per min. The quadriceps femoris, hamstrings, tibialis anterior muscle, and triceps surae were stimulated for Hybrid EMS in this study. The stimulator current waveform was used for exponential climbing pulse to reduce discomfort during muscle stimulation, and designed to produce co contractions in the lower extremity muscle groups at a frequency of 20 Hz with a pulse duration of 250 micro second. Stimulation intensity was increased until muscle contraction was observed or palpable to a maximum of 130 to 230 mA, without causing discomfort. The duty cycle was a 3s stimulation with a 3s pause for a period of 20 min. We used safety guidelines of exercise to determine if exercise training was unsafe to commence or should be ceased. The Hybrid EMS program was conducted 7 days per week, and each session consisted of 1 or 2 sets of 20 min.

Interventions/Control_2

The control group received traditional physical therapy consisting of early mobilization (range of motion exercise, upper and lower extremity exercise, ambulation, sitting on the edge of the bed, standing, sit to stand, and functional and activity of daily living exercise) for 20 to 60 min perday, for 5 to 7 days per week, until the patient was discharged from the hospital.

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

90

years-old

>=

Gender

Male and Female

Key inclusion criteria

Inclusion criteria were ICU patients who had been ventilated for more 2 days.

Key exclusion criteria

Exclusion criteria were patients with neurological disorders, stroke, traumatic brain injury, brain tumor, amputation, spinal cord injury, and ventilated for less 2 days.

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Fujisawa Chiharu

Organization

Shinko Hospital

Division name

Rehabilitation center

Zip code

Address

1-4-47, Wakinohamacho, Chuoku, Kobe, 651-0072, JAPAN

TEL

078-261-6711

Email

chiharu.fujisawa@shinkohp.or.jp

Name of contact person

1st name
Middle name
Last name	Fujisawa Chiharu

Organization

Shinko Hospital

Division name

Rehabilitation center

Zip code

Address

4-47, Wakinohamacho, Chuoku, Kobe, 651-0072, JAPAN

TEL

078-261-6711

Homepage URL

Email

chiharu.fujisawa@shinkohp.or.jp

Institute

Shinko Hospital

Institute

Department

Personal name

Organization

Japanease Physical Therapy Association

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

12

Month

06

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2016

Year

09

Month

09

Day

Date of IRB

Anticipated trial start date

2016

Year

10

Month

01

Day

Last follow-up date

2018

Year

04

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

2018

Year

04

Month

01

Day

Other related information

Registered date

2016

Year

12

Month

06

Day

Last modified on

2018

Year

07

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028944