Early Mobilization and Intensive Rehabilitation in the Critically Ill

NCT02864745 | Unknown

• 1 other identifier: 16-28663A
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

ICU acquired weakness contributes (ICUAW) to poor functional outcome in survivors of critical care. Most damage occurs during the first week of critical illness when patients are unable to cooperate with conventional active rehabilitation. Functional electrical stimulation-assisted cycle ergometry (FES-CE) may improve muscle function and long-term outcome. Methods: Assessor-blinded pragmatic single-centre randomized controlled trial. Adults (n=150) mechanically ventilated for \< 48 hours from 4 ICUs who are estimated to need \>7 days of critical care will be randomized to receive either FES-CE-based intensified rehabilitation or routine care, which will continue until ICU discharge. Primary outcome: Quality of life as measured by SF-36 score at 6 months. Secondary outcomes: functional performance at ICU discharge, cross sectional muscle diameter and nitrogen balance, and muscle power. In a subgroup we will assess insulin sensitivity and perform skeletal muscle biopsies to look at mitochondrial function, fibre typing and regulatory protein expression in response to FES-CE.

Conditions

Critical Illness

Keywords

early rehabilitation; critically ill; muscle weakness; neuromuscular stimulation; functional electrical stimulation-assisted cycle ergometry; ICUAW

Outcome Measures

Primary Outcomes (1)

• Quality of life as per 36-Item Short Health Survey (SF-36) score

  at 6 months

Secondary Outcomes (9)

• 4-item Physical Fitness in Intensive Care test

  at 28 days or discharge from ICU whichever occurs earlier

• Muscle mass measured by rectus m. crosssectional area on B-mode ultrasound

  at 7 day intervals up to 28th day or discharge from ICU, whichever occurs earlier

• Nitrogen balance measured in g/m2 of body surface area

  at 7 day intervals up to 28th day or discharge from ICU, whichever occurs earlier

• Muscle power per Medical Research Council (MRC) score

  at 7 day intervals up to 28th day or discharge from ICU, whichever occurs earlier

• Number of ventilator-free days

  at 28 days

Other Outcomes (1)

• Estimated cost of care in Euro per patient per hospital stay

  at 6 months

Study Arms (2)

Early rehabilitation arm

EXPERIMENTAL

These patients will receive very early (\<48 hours after ICU admission), protocolised, intensive rehabilitation, which will include functional electrical stimulation-assisted cycle ergometry.

Device: functional electrical stimulation-assisted cycle ergometry

Standard-of-care

ACTIVE COMPARATOR

These patients will receive standard rehabilitation delivered by non-study physiotherapist.

Other: standard rehabilitation

Interventions

functional electrical stimulation-assisted cycle ergometry DEVICE

Early intensive rehabilitation protocol, which includes the use of functional electrical stimulation-assisted cycle ergometry

Early rehabilitation arm

standard rehabilitation OTHER

This group will receive standard rehabilitation, which will be monitored, but not protocolised.

Standard-of-care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years;
• Mechanical ventilation, or imminent need of it at presentation;
• Predicted ICU length of stay ≥7 days;

You may not qualify if:

• Known primary systemic neuromuscular disease or permanent neurological damage at admission
• Severe lower limb injury or amputation
• Bedridden premorbid state
• Assessed by medical staff as approaching imminent death or withdrawal of medical treatment within 24 h
• Pregnancy
• Presence of external fixator or superficial metallic implants in lower limb
• Open wounds or skin abrasions at electrode application points
• Presence of pacemaker, implanted defibrillator or other implanted electronic medical device
• Transferred from another ICU after 24 hours of consecutive mechanical ventilation
• Presence of other condition preventing the use of FES--CE or considered unsuitable for the study by a responsible medical team
• Prior participating in another functional outcome-based intervention research study.

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• Faculty Hospital Kralovske Vinohrady: collaborator

Study Sites (1)

Kralovske Vinohrady University Hospital

Prague, 10034, Czechia

Location

Related Publications (17)

• Kress JP, Hall JB. ICU-acquired weakness and recovery from critical illness. N Engl J Med. 2014 Apr 24;370(17):1626-35. doi: 10.1056/NEJMra1209390. No abstract available.

  PMID: 24758618 BACKGROUND

• Fan E. Critical illness neuromyopathy and the role of physical therapy and rehabilitation in critically ill patients. Respir Care. 2012 Jun;57(6):933-44; discussion 944-6. doi: 10.4187/respcare.01634.

  PMID: 22663968 BACKGROUND

• Sacanella E, Perez-Castejon JM, Nicolas JM, Masanes F, Navarro M, Castro P, Lopez-Soto A. Functional status and quality of life 12 months after discharge from a medical ICU in healthy elderly patients: a prospective observational study. Crit Care. 2011;15(2):R105. doi: 10.1186/cc10121. Epub 2011 Mar 28.

  PMID: 21443796 BACKGROUND

• Fan E, Dowdy DW, Colantuoni E, Mendez-Tellez PA, Sevransky JE, Shanholtz C, Himmelfarb CR, Desai SV, Ciesla N, Herridge MS, Pronovost PJ, Needham DM. Physical complications in acute lung injury survivors: a two-year longitudinal prospective study. Crit Care Med. 2014 Apr;42(4):849-59. doi: 10.1097/CCM.0000000000000040.

  PMID: 24247473 BACKGROUND

• Herridge MS, Tansey CM, Matte A, Tomlinson G, Diaz-Granados N, Cooper A, Guest CB, Mazer CD, Mehta S, Stewart TE, Kudlow P, Cook D, Slutsky AS, Cheung AM; Canadian Critical Care Trials Group. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011 Apr 7;364(14):1293-304. doi: 10.1056/NEJMoa1011802.

  PMID: 21470008 BACKGROUND

• Herridge MS. Mobile, awake and critically ill. CMAJ. 2008 Mar 11;178(6):725-6. doi: 10.1503/cmaj.080178. No abstract available.

  PMID: 18332388 BACKGROUND

• Needham DM. Mobilizing patients in the intensive care unit: improving neuromuscular weakness and physical function. JAMA. 2008 Oct 8;300(14):1685-90. doi: 10.1001/jama.300.14.1685.

  PMID: 18840842 BACKGROUND

• Slutsky AS. Neuromuscular blocking agents in ARDS. N Engl J Med. 2010 Sep 16;363(12):1176-80. doi: 10.1056/NEJMe1007136. No abstract available.

  PMID: 20843254 BACKGROUND

• Puthucheary ZA, Rawal J, McPhail M, Connolly B, Ratnayake G, Chan P, Hopkinson NS, Phadke R, Dew T, Sidhu PS, Velloso C, Seymour J, Agley CC, Selby A, Limb M, Edwards LM, Smith K, Rowlerson A, Rennie MJ, Moxham J, Harridge SD, Hart N, Montgomery HE. Acute skeletal muscle wasting in critical illness. JAMA. 2013 Oct 16;310(15):1591-600. doi: 10.1001/jama.2013.278481.

  PMID: 24108501 BACKGROUND

• Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447.

  PMID: 18367735 BACKGROUND

• Hermans G, De Jonghe B, Bruyninckx F, Van den Berghe G. Clinical review: Critical illness polyneuropathy and myopathy. Crit Care. 2008;12(6):238. doi: 10.1186/cc7100. Epub 2008 Nov 25.

  PMID: 19040777 BACKGROUND

• Parry SM, Berney S, Koopman R, Bryant A, El-Ansary D, Puthucheary Z, Hart N, Warrillow S, Denehy L. Early rehabilitation in critical care (eRiCC): functional electrical stimulation with cycling protocol for a randomised controlled trial. BMJ Open. 2012 Sep 13;2(5):e001891. doi: 10.1136/bmjopen-2012-001891. Print 2012.

  PMID: 22983782 BACKGROUND

• Parry SM, Berney S, Warrillow S, El-Ansary D, Bryant AL, Hart N, Puthucheary Z, Koopman R, Denehy L. Functional electrical stimulation with cycling in the critically ill: a pilot case-matched control study. J Crit Care. 2014 Aug;29(4):695.e1-7. doi: 10.1016/j.jcrc.2014.03.017. Epub 2014 Mar 26.

  PMID: 24768534 BACKGROUND

• Schweickert WD, Pohlman MC, Pohlman AS, Nigos C, Pawlik AJ, Esbrook CL, Spears L, Miller M, Franczyk M, Deprizio D, Schmidt GA, Bowman A, Barr R, McCallister KE, Hall JB, Kress JP. Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial. Lancet. 2009 May 30;373(9678):1874-82. doi: 10.1016/S0140-6736(09)60658-9. Epub 2009 May 14.

  PMID: 19446324 BACKGROUND

• Burtin C, Clerckx B, Robbeets C, Ferdinande P, Langer D, Troosters T, Hermans G, Decramer M, Gosselink R. Early exercise in critically ill patients enhances short-term functional recovery. Crit Care Med. 2009 Sep;37(9):2499-505. doi: 10.1097/CCM.0b013e3181a38937.

  PMID: 19623052 BACKGROUND

• Waldauf P, Hruskova N, Blahutova B, Gojda J, Urban T, Krajcova A, Fric M, Jiroutkova K, Rasova K, Duska F. Functional electrical stimulation-assisted cycle ergometry-based progressive mobility programme for mechanically ventilated patients: randomised controlled trial with 6 months follow-up. Thorax. 2021 Jul;76(7):664-671. doi: 10.1136/thoraxjnl-2020-215755. Epub 2021 Apr 30.

  PMID: 33931570 DERIVED

• Waldauf P, Gojda J, Urban T, Hruskova N, Blahutova B, Hejnova M, Jiroutkova K, Fric M, Jansky P, Kukulova J, Stephens F, Rasova K, Duska F. Functional electrical stimulation-assisted cycle ergometry in the critically ill: protocol for a randomized controlled trial. Trials. 2019 Dec 16;20(1):724. doi: 10.1186/s13063-019-3745-1.

  PMID: 31842936 DERIVED

MeSH Terms

Conditions

Critical Illness; Muscle Weakness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Officials

• Petr Waldauf

  Faculty Hospital Kralovske Vinohrady

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Dept. of Anaesthesia and Intensive Care, 3rd Faculty of Medicine

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: August 12, 2016
• Study Start: October 4, 2016
• Primary Completion: March 10, 2020
• Study Completion: March 10, 2020
• Last Updated: October 11, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CZ (1)