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| Study identifier | Title | PI/country | Inclusion criteria | N | Study arms | Outcomes | Status, completion date |
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| NCT02520193 | Impact of Early Mobilization on Mechanical Ventilation Duration in Intubated Critically Ill Patients (EarlyMob) | Poiroux/Belgium | Age ≥ 18
Admission to ICU
MV for 24–48 hours | 772 | I: protocolized EM strategy
C: standard mobilization strategy | (1) Number of days without MV
(2) Incidence of ICUAW, pressure ulcers, delirium, hospital LOS, place of transfer at discharge, days between intubation to spontaneous breathing trial, extubation failure.Time from MV-stand up, ICU length of stay | Unknown 2018 |
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| NCT02872792 | Early Mobilization in Intensive Care Unit: Interest of Cyclo-Ergometry in Patients with Septic Chock (MUEVELO) | Beduneau/ France | Age ≥ 18
Hospitalized in ICU
Septic shock dx ≥ 24 hours
HD stable before 72 hours of MV, RASS ≤ −2
BMI ≤ 40
Contraception (WOCBA) | 234 | I: EM with cyclo-ergometer daily in addition to standard PT
C: standard PT | (1) Number of days between HD stability and discharge from ICU
(2) Number of days between HD stability and cessation of sedation
(3) Number of days under MV | Recruiting 2019 |
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| NCT02300662 | Early Mobilization for Critical Patients on Invasive Mechanical Ventilation in the Intensive Care Unit (MoVe-ICU) | Vierira/ Brazil | Age ≥ 18
ICU transfer ≤ 1 week after ER/ward
MV 24–48 hours | 28 | I: conventional PT and cycle ergometer for 20 minutes, passive movement of cycle—flexion/extension of knees and hips
C: conventional PT | (1) Change in cross-sectional quadriceps thickness
(2) Change in length of fascicle, pennation angle, thickness of vastus lateralis, diaphragm thickness and excursion | Completed 2015 |
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| NCT02312648 | Impact of Mobilization on Cardiac Surgery | Chiavegato/Brazil | Age 21–90
Elective CABG
BMI 20–30
MV < 24 hours
HD stable ± pressors
No arrhythmia/angina
MAP 60–100
HR 60–100
No respiratory distress | 52 | I: deep breath until POD#7, NIV for 30–60 minutes post extubation
Upper + lower limb ergometer exercises, limb exercises, chair transfer
C: respiratory exercises, NIV for 30–60 minutes post-extubation | (1) Functional capacity—preoperative, at hospital discharge, and 60 days postoperative (6-minute walk test)
(2) ICU and hospital length of stay, postoperative pulmonary complication | Completed 2016 |
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| NCT02864745 | Early Mobilization and Intensive Rehabilitation in the Critically Ill (EMIR) | Duska/Czech Republic | Age ≥ 18
MV or imminent need
Predicted ICU LOS ≥7 days | 150 | I: very early (<48 hours), protocolized, intensive rehabilitation—functional electrical stimulation-assisted cycle ergometry
C: standard rehab delivered by non-study PT | (1) Quality of life—Short Form 36 score
(2) 4-item physical fitness in ICU, muscle mass, nitrogen balance, muscle power, number ventilator free days, number rehab interruptions, number episodes of elevated ICP, number dialysis interruptions, ICU LOS | Recruiting 2019 |
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| NCT03554811 | Early Rehabilitation using Functional Electrical Stimulation-Assisted Supine Cycling in the Intensive Care Unit | Smith/USA | Age ≥ 18
Predicted ICU LOS ≥4 days
Expected ICU survival
Expected MV > 48 hours
Can perform outcome measures premorbidly | 32 | I: functional electrical stimulation-assisted supine cycling within 48 hours of ICU admission
C: conventional early exercise and mobility interventions—standard ICU exercise and mobility as per alertness and stability | (1) Percent change of rectus femoris cross-sectional area (baseline, weekly, at ICU discharge and hospital discharge)
(2) Diaphragm muscle thickness by ultrasound, muscle strength (MRCS), physical function (PFIT, FFS-ICU, SPPB, 6MWT), quality of life (SF-36 survey), cognition (MoCA), hospital LOS, ICU LOS, duration of MV | Not yet recruiting 2020 |
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| NCT03229070 | Cycle Ergometer in the Postoperative of Thoracic Surgery (CE_PTS) | Macagna/ Brazil | Age 30–80
Planned thoracotomy, VATS for pulmonary resection
Extubated
HD stable MAP 60–100, HR 50–100 O2 saturation ≥ 90%
Prescription for respiratory and motor PT | 135 | IA: interval effort group: high load -> active recovery phase with light to moderate load
1B: continuous effort group: mild to moderate intensity
C: standard care | (1) 6MWT
(2) Number of success on lift and sit on chair | Not yet recruiting 2018 |
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| NCT03133377 | Treatment of Invasively Ventilated Adults with Early Activity and Mobilization (TEAM (III)) | Hodgson/Australia | Age ≥ 18
MV for 2 or more days
HD stable
Respiratory stability | 750 | I: daily assessment by ICU PT using IMS scale, protocol is hierarchical
C: standard care by PT | (1) Number of days alive and out of hospital
(2) Mortality, ventilator-free days, ICU-free days, quality of life, EQ5D-5L, Barthel’s basic activities of daily living, Lawton’s instrumental activities of daily living, WHODAS.
Others: delirium-free days, MoCA, HADS, and IES-R scores | Recruiting 2021 |
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| NCT03771014 | A Feasibility Study of Early Mobilization Programmes in Critical Care (EMPRESS) | Cusack/United Kingdom | Age ≥ 42
ICU admission
Independent (barthel > 80)
in hospital <5 days
Expected MV for 48 hours | 90 | I: standard PT regimen and 2 times 30 minutes rehabilitation sessions 5 days per week
C: standard care PT | (1) Physical function ICU test score
(2) Muscle strength and function MRC, handheld dynamometry, CPAX, time up and go, clinical frailty score, Barthel ADL, 6MWT, HADS WHODAS, EQ5D-5L | Not yet recruiting 2021 |
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| NCT03770442 | Muscle Wasting in the Critically Ill | Welters/United Kingdom | Age 18–90
ICU admission
MV and initial sedation
Definite or suspected sepsis of any source | 36 | I: cycling with functional electrical stimulation (FES).
Will also receive routine PT.
C: routine PT | (1) Change in muscle thickness or fascicle pennation angle of various muscles. Change in thickness with respiration.
(2) Change in blood or urine biomarkers, 6MWT, hand grip dynamometry, limb strength, balance, SF-36, MIP, CAM ICU, RRT, total dose of noradrenaline, fluid balance, insulin per day, glucose, HR variability, safety measures | Not yet recruiting 2020 |
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| NCT01705015 | Organ Transplantation Rehabilitation: Effect of Bedside Exercise Devices and Activity Reinforcement | Chen/Taiwan | Age 18–80
After heart or liver transplant at NTUH
Independent 6 weeks preadmission | 110 | I: ICFit and direct feedback—encouraged to look at summary of daily data and encouraged to pedal
C: UCFit and encouraged—graph of mins cycled left at bedside | (1) Level of independence for walking 150 feet; walking speed for 50 feet; 6MWT; cardiopulmonary exercise testing
(2) total exercise; SF-36; LOS; rate of rehospitalization; complications to exercise | Unknown 2015 |
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| ACTRN12618000374268 | The Effectiveness of Early Functional Occupation-Based Retraining Therapy in a Medical/Surgical Intensive Care Unit | Rapolthy-Beck/Australia | Age ≥ 18
ICU admission
Expected MV ≥ 48 hours | 30 | I: (I) performance-based and cognitive stimulation
(II) Qualitative component –explore experience of participants
C: usual OT care | (1) Independence for activities of daily living (FIM) at discharge and 90 days follow-up
(2) Functional ability (modified Barthel’s), MoCA, dynamometer, SF-36, HADS, RASS, GCS, CAM-ICU | Recruiting 2020 |
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| ACTRN12614001059651 | Effects of Combined Electrical Muscle Stimulation and Resistance Exercises in Duration of Mechanical Ventilation in Critically Ill Patients | Vieira/ Brazil | Age ≥ 18
ICU admission
MV | 40 | I: resistance exercise, electrical mechanical stimulation, or both
C: usual care by respiratory PT | (1) Duration of MV
(2) LOS in ICU, biomarker analysis (IGF-1, IL1B, IL-6, IL-10, IL-18, TNF-a) performed at baseline and at ICU discharge | Completed 2015 |
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| ACTRN12614000763640 | A Randomized Controlled Study of the Awakening and Breathing Trial Coordination; Delirium Monitoring and Management; and Early Exercise and Mobility (ABCDE) Bundle to Improve Functional and Cognitive Capacity in Ventilated Critically Ill Patients | Sosnowski/Australia | Age 18–99
MV ≥ 48 hours | 100 | I: daily SBT and SAT, delirium assessment and exercise to identify etiology and minimize, target RASS
C: standard therapy without use of any protocols | (1) Physical function ICU test, MoCA, and Barthel index (2) RASS scale, CAM-ICU | Not yet recruiting 2014 |
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