eStimCycle: Early Rehabilitation in Critical Care

NCT ID: NCT02214823

Last Updated: 2018-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2018-10-31

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

FES-Cycling

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.

Group Type: EXPERIMENTAL

FES-Cycling

Intervention Type: DEVICE

Standard Care

Intervention Type: OTHER

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

Standard Care

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.

Group Type: ACTIVE_COMPARATOR

Standard Care

Intervention Type: OTHER

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

Interventions

FES-Cycling

Intervention Type: DEVICE

Standard Care

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

Intervention Type: OTHER

Other Intervention Names

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

Eligibility Criteria

Inclusion Criteria

1. ≥18 years,

2. 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

3. predicted ICU length of stay ≥4 days.

Exclusion Criteria

1. Known primary systemic neuromuscular disease or intracranial process on ICU admission

2. Lower limb amputation/s

3. Unable to perform study physical outcome measures pre morbidly due to condition impairing mobility

4. Assessed by medical staff as not-expected to survive ICU

5. Pregnancy

6. BMI > 40

7. Presence of external fixator or superficial metal in lower limb

8. Open wounds or skin abrasions at electrode application points

9. Presence of cardiac or diaphragmatic pacemaker or implanted defibrillator with no underlying rhythm, as confirmed by the treating physician

10. Transferred from another ICU after > 2 days of mechanical ventilation

11. Platelets < 40 000 and INR > 1.6 (for muscle biopsy)

12. Lower limb malignancy

13. Pre-existing intellectual disability or cognitive impairment limiting the ability to accurately follow instructions.

14. Non-English speaking background restricting the individuals ability to accurately and consistently follow instructions.

1. Cognitive impairment (IQCODE >3.3) done by proxy after informed consent obtained

2. No fixed home address

3. Score >= 10 on Alcohol use disorders and identification test (AUDIT)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Associate Professor Sue Berney PhD, BPT

OTHER

Sponsor Role: lead

Responsible Party

Associate Professor Sue Berney PhD, BPT

Associate Professor, Head of Physiotherapy, Austin Hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Linda Denehy, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Melbourne

Susan Berney, PhD

Role: PRINCIPAL_INVESTIGATOR

Austin Health

Dale Needham, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Jennifer Paratz, PhD

Role: PRINCIPAL_INVESTIGATOR

Royal Brisbane and Women's Hospital

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Duke University

Durham, North Carolina, United States

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Austin Hospital

Melbourne, Victoria, Australia

Countries

United States; Australia

References

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.

Reference Type: BACKGROUND

PMID: 22983782 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23921276 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24768534 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33323480 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25888469 (View on PubMed)

Other Identifiers

ACTRN12612000528853

Identifier Type: -

Identifier Source: org_study_id