UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025162 |
|---|---|
| Receipt number | R000028944 |
| Scientific Title | Effect of electrical muscle stimulation-induced passive leg cycle ergometer training on ventilated intensive care unit patients. |
| Date of disclosure of the study information | 2016/12/06 |
| Last modified on | 2018/07/10 12:57:25 |
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Basic information
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
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
| 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
chiharu.fujisawa@shinkohp.or.jp
Public contact
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
chiharu.fujisawa@shinkohp.or.jp
Sponsor or person
Institute
Shinko Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028944
