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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02214823




Registration number
NCT02214823
Ethics application status
Date submitted
7/08/2014
Date registered
12/08/2014
Date last updated
11/10/2018

Titles & IDs
Public title
eStimCycle: Early Rehabilitation in Critical Care
Scientific title
Functional Electrical Stimulation Assisted Cycling (eStimCycle):A Novel Intervention to Improve Outcomes in the Critically Ill
Secondary ID [1] 0 0
ACTRN12612000528853
Universal Trial Number (UTN)
Trial acronym
eStimCycle
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intensive Care Unit Acquired Weakness (ICUAW) 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Standard Care

Experimental: 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.

Active comparator: 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.


Other interventions: 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 code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Muscle mass and cross sectional area
Timepoint [1] 0 0
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 outcome [2] 0 0
Muscle Strength
Timepoint [2] 0 0
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 outcome [3] 0 0
Neuropsychological Battery of Tests
Timepoint [3] 0 0
6 and 12 months post ICU discharge
Secondary outcome [1] 0 0
Biomarker analyses
Timepoint [1] 0 0
Baseline and ICU discharge with an expected average stay of 14 days
Secondary outcome [2] 0 0
Hours of mechanical ventilation, ICU hours and ICU readmission
Timepoint [2] 0 0
trial completion
Secondary outcome [3] 0 0
Confusion Assessment Method for ICU (CAM-ICU)
Timepoint [3] 0 0
Daily in ICU for an expected average of 14 days
Secondary outcome [4] 0 0
Montreal Cognitive Assessment (MoCA)
Timepoint [4] 0 0
Hospital discharge and expected stay on average of 4 weeks
Secondary outcome [5] 0 0
Activities of Daily Living and Instrumental Activities of Daily Living
Timepoint [5] 0 0
Baseline, 90-day status, 6-month call
Secondary outcome [6] 0 0
Physical function
Timepoint [6] 0 0
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 outcome [7] 0 0
Informant Questionnaire on Cognitive Decline in the Elderly, short form (IQCODE-SF)
Timepoint [7] 0 0
Baseline
Secondary outcome [8] 0 0
Hospital Anxiety and Depression Scale
Timepoint [8] 0 0
6 and 12 months post recruitment
Secondary outcome [9] 0 0
Impact of Events Scale - Revised (IES-R)
Timepoint [9] 0 0
6 and 12 months post recruitment

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2018
Sample size
Target
Accrual to date
Final
162
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [2] 0 0
Austin Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
4006 - Herston
Recruitment postcode(s) [2] 0 0
3084 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Maryland
Country [2] 0 0
United States of America
State/province [2] 0 0
North Carolina

Funding & Sponsors
Primary sponsor type
Other
Name
Associate Professor Sue Berney PhD, BPT
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT02214823
Trial related presentations / publications
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.
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.
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Linda Denehy, PhD
Address 0 0
University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02214823