eStimCycle: Early Rehabilitation in Critical Care

NCT02214823 | Completed DMC

• 1 other identifier: ACTRN12612000528853
• Study Type: interventional
• Target: 162
• Locations: 2 countries
• Sites: 4

Brief Summary

Project Summary: Patients who have a length of stay four or more days in ICU and requiring mechanical ventilation assistance to breathe for more than 48 hours will be invited to participate. Participants will be randomised to either receive Functional Electrical Stimulation (eStimCycle) assisted cycling or standard care. As cycling in bed has previously been shown to improve physical function, patients who receive cycling as a treatment will have one leg that cycles and the other leg that cycles with assistance of electrical stimulation as we want to establish the effectiveness of the addition of electrical stimulation of muscle. Muscle bulk, strength and physical function outcome measures will be measured at baseline, weekly in ICU, ICU discharge and hospital discharge. Cognitive function will also be measured at hospital discharge, 6- and 12-month follow-up. A small group of patients in this study will be invited to provide samples of blood, urine and muscle at ICU admission and discharge to try and determine what happens to muscle in patients who are critically ill. Significance of the Project: This is an important study because the development of ICU-acquired weakness (ICU-AW) can result in long term limitations in physical function. Early treatment to maintain strong muscles during an intensive care stay may help speed up recovery and enhance participation in other rehabilitation treatments and improve functional activities and cognition. These are important objectives for both patients and their families. In addition understanding why the muscles become so weak so quickly in patients in ICU will help to develop treatments that may help to maintain muscle strength. Study Hypotheses: Hypothesis 1: eStimCycle versus usual care rehabilitation will improve muscle strength at hospital discharge. Hypothesis 2: eStimCycle versus usual care rehabilitation will improve cognitive function at 6 month follow up. Hypothesis 3: Patients receiving eStimCycle will have improved activity of anabolic signalling pathways and less atrophy of skeletal muscle fibre size compared with usual care rehabilitation.

Conditions

Intensive Care Unit Acquired Weakness (ICUAW)

Outcome Measures

Primary Outcomes (3)

• Muscle mass and cross sectional area

  Bioimpedance Spectroscopy will be used to evaluate changes in muscle mass. Ultrasonography of the quadriceps will assess changes in muscle thickness and cross sectional area

  Baseline, weekly in ICU for an average 2 weeks and at CU discharge (on average 14 days) with participants beng followed for the duration of hospital stay, an expected average of 4 weeks

• Muscle Strength

  This will be assessed using the Medical Research Council Scale for identifying muscle weakness in ICU and also hand-held dynamometry for grip strength and isometric quadriceps strength

  Baseline, weekly in ICU for an average 2 weeks and at ICU discharge (on average 14 dats) with participants beng followed for the duration of hospital stay on average of 4 weeks. Hand-held dynamometry will also be assessed at 6 and 12 months.

• Neuropsychological Battery of Tests

  Including the following tests: Hayling Sentence Completion, Weschler Adult Intelligence Scale (Digit Span and Similarities), Weschler Memory III (Logical Memory 1 and 2) and Cognistat (Judgment and Orientation), and Controlled Oral Word Association

  6 and 12 months post ICU discharge

Secondary Outcomes (9)

• Biomarker analyses

  Baseline and ICU discharge with an expected average stay of 14 days

• Hours of mechanical ventilation, ICU hours and ICU readmission

  trial completion

• Confusion Assessment Method for ICU (CAM-ICU)

  Daily in ICU for an expected average of 14 days

• Montreal Cognitive Assessment (MoCA)

  Hospital discharge and expected stay on average of 4 weeks

• Activities of Daily Living and Instrumental Activities of Daily Living

  Baseline, 90-day status, 6-month call

Study Arms (2)

FES-Cycling

EXPERIMENTAL

Timeframe: Within 72 hours of ICU admission. Program: Standard care physiotherapy AND up to one hour of supine cycling daily using a cycle ergometer (RT300 supine model Restorative Therapies, Ltd or Letto 300.) attached to a six channel stimulator (SAGE) and 2 additional RT50 wireless stimulator channels. One leg will undergo cycling alone without the electrodes turned on (sham) and the other leg will undergo cycling and muscle stimulation. Electrodes will be placed on all major lower limb muscles. Intervention will be provided individually and supervised by a physiotherapist in ICU only. Duration /Intensity: Up to 1 hour at least 5 times a week for 28 days or ICU discharge, if 20 sessions have not occurred at this time, intervention will continue until this is achieved. Intensity of muscle stimulation will be delivered at a level able to cause visible muscle contractions, confirmed by palpation. A subgroup of 10 individuals will be involved in biomarker analyses.

Device: FES-Cycling; Other: Standard Care

Standard Care

ACTIVE COMPARATOR

Both groups will receive usual medical and nursing care in the ICU and ward. Both groups (control and intervention) will receive standard care physiotherapy including respiratory and rehabilitation with mobilisation activities such as sitting out of bed, marching on the spot, and mobility training. A subgroup of 10 individuals will be involved in biomarker analyses. This will involve collection of muscle biopsy, blood and urine analyses at baseline and ICU discharge.

Other: Standard Care

Interventions

FES-Cycling DEVICE

Also known as: Cycle ergometer (RT300 supine model Restorative Therapies, Ltd or Letto 300.), six channel SAGE stimulator and two RT50 wireless stimulator channels.

FES-Cycling

Standard Care OTHER

standard care physiotherapy including respiratory and rehabilitation with mobilisation activities such as sitting out of bed, marching on the spot, and mobility training.

FES-Cycling; Standard 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,
• expected mechanical ventilation or ECMO \>48 h with evidence of systemic inflammation as defined by American College of Chest Physicians (ACCP) Consensus Conference Criteria and
• predicted ICU length of stay ≥4 days.

You may not qualify if:

• Known primary systemic neuromuscular disease or intracranial process on ICU admission
• Lower limb amputation/s
• Unable to perform study physical outcome measures pre morbidly due to condition impairing mobility
• Assessed by medical staff as not-expected to survive ICU
• Pregnancy
• BMI \> 40
• Presence of external fixator or superficial metal in lower limb
• Open wounds or skin abrasions at electrode application points
• Presence of cardiac or diaphragmatic pacemaker or implanted defibrillator with no underlying rhythm, as confirmed by the treating physician
• Transferred from another ICU after \> 2 days of mechanical ventilation
• Platelets \< 40 000 and INR \> 1.6 (for muscle biopsy)
• Lower limb malignancy
• Pre-existing intellectual disability or cognitive impairment limiting the ability to accurately follow instructions.
• Non-English speaking background restricting the individuals ability to accurately and consistently follow instructions.
• Cognitive impairment (IQCODE \>3.3) done by proxy after informed consent obtained

Sponsors & Collaborators

• Associate Professor Sue Berney PhD, BPT: lead

Study Sites (4)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Duke University

Durham, North Carolina, 27708, United States

Location

Royal Brisbane and Women's Hospital

Herston, Queensland, 4006, Australia

Location

Austin Hospital

Melbourne, Victoria, 3084, Australia

Location

Related Publications (5)

• 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, Granger CL, Koopman R, El-Ansary D, Denehy L. Electrical muscle stimulation in the intensive care setting: a systematic review. Crit Care Med. 2013 Oct;41(10):2406-18. doi: 10.1097/CCM.0b013e3182923642.

  PMID: 23921276 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

• Berney S, Hopkins RO, Rose JW, Koopman R, Puthucheary Z, Pastva A, Gordon I, Colantuoni E, Parry SM, Needham DM, Denehy L. Functional electrical stimulation in-bed cycle ergometry in mechanically ventilated patients: a multicentre randomised controlled trial. Thorax. 2021 Jul;76(7):656-663. doi: 10.1136/thoraxjnl-2020-215093. Epub 2020 Dec 15.

  PMID: 33323480 DERIVED

• Parry SM, Denehy L, Beach LJ, Berney S, Williamson HC, Granger CL. Functional outcomes in ICU - what should we be using? - an observational study. Crit Care. 2015 Mar 29;19(1):127. doi: 10.1186/s13054-015-0829-5.

  PMID: 25888469 DERIVED

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Linda Denehy, PhD

  University of Melbourne

  PRINCIPAL INVESTIGATOR

• Susan Berney, PhD

  Austin Health

  PRINCIPAL INVESTIGATOR

• Dale Needham, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Jennifer Paratz, PhD

  Royal Brisbane and Women's Hospital

  PRINCIPAL INVESTIGATOR

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: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Head of Physiotherapy, Austin Hospital

Study Record Dates

• First Submitted: August 7, 2014
• First Posted: August 12, 2014
• Study Start: July 1, 2012
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: October 11, 2018

Record last verified: 2018-10

Locations

US (2); AU (2)