Intensive Care Unit Acquired Weakness (ICUAW) Clinical Trial
— eStimCycleOfficial title:
Functional Electrical Stimulation Assisted Cycling (eStimCycle):A Novel Intervention to Improve Outcomes in the Critically Ill
| Verified date | October 2018 |
| Source | University of Melbourne |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 162 |
| Est. completion date | October 2018 |
| Est. primary completion date | October 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. Exclusion criteria for the 6 and 12 month cognitive testing follow-up portion of the study: 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) |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Royal Brisbane and Women's Hospital | Herston | Queensland |
| Australia | Austin Hospital | Melbourne | Victoria |
| United States | Johns Hopkins University | Baltimore | Maryland |
| United States | Duke University | Durham | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Associate Professor Sue Berney PhD, BPT |
United States, Australia,
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. Review. — View Citation
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). pii: e001891. doi: 10.1136/bmjopen-2012-001891. Print 2012. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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. | |
| Primary | 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 | Biomarker analyses | Muscle biopsy, 24 hour urine collection and blood analyses in subgroup of n=20 from main pilot randomised controlled trial. | Baseline and ICU discharge with an expected average stay of 14 days | |
| Secondary | Hours of mechanical ventilation, ICU hours and ICU readmission | This will be collected from medical records data. This will all be reported at the completion of the trial | trial completion | |
| Secondary | Confusion Assessment Method for ICU (CAM-ICU) | The CAM-ICU is a tool for screening for delirium in critically ill patients. | Daily in ICU for an expected average of 14 days | |
| Secondary | Montreal Cognitive Assessment (MoCA) | A screening tool for cognitive impairment | Hospital discharge and expected stay on average of 4 weeks | |
| Secondary | Activities of Daily Living and Instrumental Activities of Daily Living | Two short and simple questionnaires assessing activities of daily living. | Baseline, 90-day status, 6-month call | |
| Secondary | Physical function | The physical function in ICU test (PFIT), functional status score in the ICU (FSS-ICU), short physical performance battery (SPPB) and six minute walk test (6MWT). | Baseline and then weekly until ICU discharge an expected stay on average of 14 days. SPPB and 6MWT will also be measured at hospital discharge with an average length of stay of 4 weeks. 6MWT will be assessed and 6 and 12 months. | |
| Secondary | Informant Questionnaire on Cognitive Decline in the Elderly, short form (IQCODE-SF) | The IQCODE-SF for cognitive dysfunction will be completed at baseline by the proxy after obtaining informed consent. | Baseline | |
| Secondary | Hospital Anxiety and Depression Scale | A scale used to detect the states of anxiety and depression | 6 and 12 months post recruitment | |
| Secondary | Impact of Events Scale - Revised (IES-R) | IES-R is an instrument to measure the subjective response to a specific traumatic event, especially in the response sets of intrusion (intrusive thoughts, nightmares, intrusive feelings and imagery, dissociative-like re-experiencing), avoidance (numbing of responsiveness, avoidance of feelings, situations, and ideas), and hyperarousal (anger, irritability, hypervigilance, difficulty concentrating, heightened startle), as well as a total subjective stress IES-R score. | 6 and 12 months post recruitment |