UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of electrical muscle stimulation-induced passive leg cycle ergometer training on ventilated intensive care unit patients.
Title of the study (Brief title)	Effect of hybrid EMS on ventilated ICU patients.
Region	Japan

Condition
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

Objectives
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

Assessment
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

Base
Study type	Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Fujisawa Chiharu
Organization	Shinko Hospital
Division name	Rehabilitation center
Address	1-4-47, Wakinohamacho, Chuoku, Kobe, 651-0072, JAPAN
TEL	078-261-6711
Email	chiharu.fujisawa@shinkohp.or.jp

Public contact
Name of contact person	Fujisawa Chiharu
Organization	Shinko Hospital
Division name	Rehabilitation center
Address	4-47, Wakinohamacho, Chuoku, Kobe, 651-0072, JAPAN
TEL	078-261-6711
Homepage URL
Email	chiharu.fujisawa@shinkohp.or.jp

Sponsor
Institute	Shinko Hospital
Institute
Department

Funding Source
Organization	Japanease Physical Therapy Association
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 12 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 12 Month 06 Day
Last modified on	2018 Year 07 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028944