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Trial registered on ANZCTR


Registration number
ACTRN12616000948493
Ethics application status
Approved
Date submitted
12/07/2016
Date registered
18/07/2016
Date last updated
7/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Does in-bed cycling with critically ill patients assist to maintain muscle mass and function?
Scientific title
A randomised controlled trial of in-bed cycling with critically ill patients on maintaining quadriceps muscle mass.
Secondary ID [1] 289642 0
None
Universal Trial Number (UTN)
Trial acronym
CYCLIST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical illness 299436 0
Intensive Care Unit Acquired Weakness (ICUAW) 299437 0
Sepsis 299438 0
Condition category
Condition code
Physical Medicine / Rehabilitation 299418 299418 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Group:
Timeframe: Within 120 hours of ICU admission until ICU discharge (28 days maximum) post ICU admission (whichever occurs sooner)

Program: In addition to usual standard of care physiotherapy interventions the intervention group will complete daily (Mon-Fri) additional progressive lower limb in-bed cycling using a bedside cycle ergometer (MOTOmed Letto 2) for 30-minutes .
Patients who are sedated or in a state of low arousal will cycle continuously and passively for 30 minutes at a cadence of 20 rpm.
Once the patient is able to follow commands they will be asked to cycle actively. The cycle ergometer will be adjusted to facilitate progression of intensity throughout the sessions (within safe limits, specified in stopping criteria). A physiotherapist with experience in prescribing exercise programs for critically ill patients will adjust the intensity of the in-bed cycling intervention based on the patients' physiological parameters and muscular endurance.
This will enable the patient to cycle in-bed either passively or actively (as able) with assistance from the cycle ergometer.
The patients’ cardiorespiratory and cardiovascular values will be monitored throughout the exercise intervention.
Patients will be progressed to exercise at the highest level of resistance that they tolerate whilst maintaining physiological values within pre-specified stopping criteria.
In-bed cycling sessions will continue until the patient completes a minimum of 5 cycle in-bed cycling sessions.
In-bed cycling sessions will continue in the acute hospital ward after discharge from ICU if the patient is discharged from ICU prior to completing 5 in-bed cycling sessions.
In-bed cycling sessions will continue until ICU discharge (28 days maximum), the maximum number of in-bed cycling sessions that could be completed is 20.
Intervention code [1] 295258 0
Rehabilitation
Comparator / control treatment
Control group (standard care):
Participants in the comparator group will receive usual physiotherapy interventions whilst an inpatient in intensive care. Physiotherapy interventions will be implemented by the usual treating physiotherapists in the unit and typically include respiratory physiotherapy and exercise interventions inclusive of sitting on the edge of the bed, sit to stand transfers, sitting out of bed and walking.

Both groups will receive usual , medical, nursing and allied health care in the ICU and elsewhere in the hospital following discharge from the ICU.
Control group
Active

Outcomes
Primary outcome [1] 298886 0
Percentage of change in cross-sectional area of rectus femoris measured by ultrasound scan.
Timepoint [1] 298886 0
Change (from baseline) at Day 10 post study enrolment is the primary endpoint for the primary outcome
(although measurements will also be taken at other timepoints e.g. day 3, day 7, 7 days post discharge from ICU).
Secondary outcome [1] 325539 0
Percentage of change in anterior to posterior muscle thickness of rectus femoris measured by ultrasound scan
Timepoint [1] 325539 0
Baseline (within 24 hours of study enrolment), day 3, 7 and 10 (primary end-point) and day 7 post ICU discharge
Secondary outcome [2] 325540 0
Percentage of change in anterior to posterior muscle thickness of vastus intermedius measured by ultrasound scan
Timepoint [2] 325540 0
Baseline (within 24 hours of study enrolment), day 3, 7 and 10 (primary end-point) and day 7 post ICU discharge
Secondary outcome [3] 325541 0
Muscle strength
Measured by Medical Research Council Sum-Score
Timepoint [3] 325541 0
ICU discharge and one week post ICU discharge
Secondary outcome [4] 325542 0
Muscle strength
Measured by hand-grip dynamometry
Timepoint [4] 325542 0
ICU discharge and one week post ICU discharge
Secondary outcome [5] 325543 0
Functional outcomes
Time to achieve functional milestones (time to stand, sit out of bed, mobilise and mobilise independently).
Timepoint [5] 325543 0
Daily in ICU
Secondary outcome [6] 325544 0
Functional outcome
Functional Status Score - ICU (FSS-ICU)
Timepoint [6] 325544 0
ICU discharge and one week post ICU discharge
Secondary outcome [7] 325545 0
Functional outcome
ICU Mobility Scale (IMS).
Timepoint [7] 325545 0
Measured daily in ICU
Secondary outcome [8] 325676 0
Walking endurance measured by the 6 minute walk test
Timepoint [8] 325676 0
One week post ICU discharge
Secondary outcome [9] 325677 0
Quality of Life measured by the EQ-5D
Timepoint [9] 325677 0
Day 10 post ICU admission and 3 months post discharge
Secondary outcome [10] 325678 0
Incidence of delirium measured by the Confusion Assessment Method for the intensive care unit (CAM-ICU)
Timepoint [10] 325678 0
Daily whilst an inpatient in ICU
Secondary outcome [11] 325679 0
Duration of delirium measured by the Confusion Assessment Method for the intensive care unit (CAM-ICU)
Timepoint [11] 325679 0
Daily whilst an inpatient in ICU
Secondary outcome [12] 325680 0
Patient perspectives (intervention group) assessed by a customised acceptability of intervention questionnaire
Timepoint [12] 325680 0
Day 10 post ICU admission or at completion of cycle ergometry sessions.

Eligibility
Key inclusion criteria
Critically ill patients admitted to ICU who are:
(i) expected to require >48 hours of mechanical ventilation,
(ii) able to provide consent or have a family member consent on their behalf,
(iii) enrolled into the study within 96 hours of ICU admission,
(iv) expected to remain in ICU for >48 hours following study enrolment.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) The presence of a pre-existing condition that is likely to impair mobility or the assessment of mobility following enrolment (e.g. neurological, musculoskeletal, cognitive or mental health disorder likely to impair daily function)
ii) Diagnosed or suspected acute primary brain lesion (e.g. traumatic brain injury, intracranial haemorrhage, stroke, hypoxic brain injury or neuromuscular disorder) that is likely to impair daily function.
iii) Injuries where in-bed cycling would be contraindicated (e.g. some spinal / pelvic / lower limb orthopaedic injuries / open abdominal wound).
iv) Death is deemed to be imminent or inevitable during this admission
v) Obesity (greater than 135 kg) as the maximum weight capacity for the in-bed cycle ergometer is 135 kg. (MOTOmed Letto 2)
vi) Has acute deep vein thrombosis or pulmonary embolism
vii) Acute coronary syndrome (evidence of coronary ischaemia e.g. chest pain or ECG changes)
viii) Uncontrolled seizures or status epilepticus
ix) Pregnancy

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)
The random allocation sequence, with variable block sizes will be concealed and uploaded on the Research Electronic Data Capture (REDCap) secure web based clinical trial workflow software. The REDCap randomisation module will be utilised to only reveal the allocation of the participant to either the control or intervention group to the intervention co-coordinator for the trial.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Offsite research personnel not involved in the day to day operation of the trial will use computerised random number generation to create a randomisation sequence. A treatment to control ratio of 1:1 and (random) block sizes will be used to minimise risk of potential differences in group sizes. Only the randomisation sequence generator will know the block sizes used.
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)
Efficacy
Statistical methods / analysis
Descriptive statistics and generalized linear mixed models will be used to examine the effect of group allocation (intervention vs. control) on the primary and secondary outcomes. As this is a randomised trial we do not plan to adjust for potential confounders (e.g., age, gender, comorbidities), but will compare the characteristics of the sample by treatment group and may adjust if a potential confounder differs greatly between groups).
Given the repeated measures design, a sample size calculation has estimated this sample will have 80% power to detect a 2.9% between group mean difference in cross sectional area change of Rectus Femoris; assuming alpha 0.05, standard deviation of 6%, and correlation of 0.5% between assessments after taking into account a drop-out rate of up to 20% . Data will be analysed and reported using an intention to treat analysis,
Additional analysis: A per protocol analysis may also be conducted (as a secondary or sensitivity analysis) if substantial variations from the intended treatment protocol are observed. If conducted, per protocol analysis will comprise participants who adhere to the protocol and received at least 80% of training sessions (minimum of 4 sessions).

The following sub-analyses are planned:
Analysis of muscle wasting examining the association with: number/ severity of vital organs assessed to have dysfunction/failure utilising a Sequential Organ Failure Score (SOFA); severity of illness on admission to ICU utilising APACHE II and APACHE III data; rectus femoris muscle cross sectional area at initial assessment.; number of days to a patient commences active activity; sedative and paralytic medications.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 6145 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 13584 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 294024 0
Government body
Name [1] 294024 0
Metro South Health Centres for Health Research
Address [1] 294024 0
Princess Alexandra Hospital
Centres for Health Research
Level 7 Translational Research Institute
37 Kent Street
Woolloongabba
QLD 4102
Country [1] 294024 0
Australia
Funding source category [2] 294054 0
Hospital
Name [2] 294054 0
Princess Alexandra Hospital
Address [2] 294054 0
Ipswich Rd
Woolloongabba
QLD 4102
Country [2] 294054 0
Australia
Primary sponsor type
Individual
Name
Marc Nickels
Address
Physiotherapy Department
Princess Alexandra Hospital
Ipswich Rd
Woolloongabba
QLD 4102
Country
Australia
Secondary sponsor category [1] 292843 0
Individual
Name [1] 292843 0
Assoc Prof Steven McPhail
Address [1] 292843 0
Centre for Functioning and Health Research
Level 3 Buranda Village
Cnr. Ipswich Rd and Cornwell St
Buranda
QLD 4102
Country [1] 292843 0
Australia
Secondary sponsor category [2] 292845 0
Individual
Name [2] 292845 0
Professor Leanne Aitken
Address [2] 292845 0
School of Health Sciences,
City University London
Northampton Square
London EC1V 0HB
Country [2] 292845 0
United Kingdom
Secondary sponsor category [3] 292846 0
Individual
Name [3] 292846 0
Assoc Prof Adrian Barnett
Address [3] 292846 0
Queensland University of Technology,
60 Musk Avenue,
Kelvin Grove,
QLD 4059
Country [3] 292846 0
Australia
Secondary sponsor category [4] 292847 0
Individual
Name [4] 292847 0
Dr James Walsham
Address [4] 292847 0
Intensive Care Unit
Princess Alexandra Hospital
Ipswich Rd
Woolloogabba,
QLD 4102
Country [4] 292847 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295434 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 295434 0
Centres for Health Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba
QLD 4102
Ethics committee country [1] 295434 0
Australia
Date submitted for ethics approval [1] 295434 0
Approval date [1] 295434 0
28/04/2016
Ethics approval number [1] 295434 0
HREC/16/QPAH/193

Summary
Brief summary
Critically ill patients often require prolonged mechanical ventilation for periods greater than 48 hours. It has been identified that skeletal muscle wasting occurs early and rapidly during the first week of critical illness. Despite international recommendations to commence activity as early as possible with critically ill patients it has been identified that exercise interventions are rarely initiated when a patient is on mechanical ventilation. This leads to prolonged immobility and may contribute to the development of ICU Acquired Weakness (ICUAW).

A randomised controlled trial (RCT) will compare outcomes of critically ill patients who receive standard physiotherapy (control group) and those who complete additional in-bed cycling intervention sessions. This will enable comparison of outcomes to assist clinicians to determine if additional in-bed cycling sessions may be beneficial with critically ill patients.

Objectives:
To determine:
(1) if in-bed cycling in addition to standard care is effective in reducing the rate of rectus femoris (RF) cross-sectional area (CSA) atrophy and intensive care unit acquired weakness (ICUAW) in patients requiring > 48 hrs of mechanical ventilation compared to standard care;
(2) whether in-bed cycling in addition to standard care improved functional and cognitive outcomes in patients requiring > 48 hours of mechanical ventilation compared to standard care.

Trial Design: Two (parallel) arm, preliminary randomised control trial with assessor blinding.

In summary, this study aims to examine if addition of an in-bed cycling intervention with critically ill patients reduces the loss of thigh muscle mass. Also to examine if in-bed cycling improves functional and cognitive outcomes post intensive care discharge.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67306 0
Mr Marc Nickels
Address 67306 0
Physiotherapy Department
Princess Alexandra Hospital
Ipswich Rd
Woollgabba
QLD 4102
Country 67306 0
Australia
Phone 67306 0
+61 7 31762401
Fax 67306 0
Email 67306 0
marc.nickels@health.qld.gov.au
Contact person for public queries
Name 67307 0
Mr Marc Nickels
Address 67307 0
Physiotherapy Department
Princess Alexandra Hospital
Ipswich Rd
Woollgabba
QLD 4102
Country 67307 0
Australia
Phone 67307 0
+61 7 31762401
Fax 67307 0
Email 67307 0
marc.nickels@health.qld.gov.au
Contact person for scientific queries
Name 67308 0
Mr Marc Nickels
Address 67308 0
Physiotherapy Department
Princess Alexandra Hospital
Ipswich Rd
Woollgabba
QLD 4102
Country 67308 0
Australia
Phone 67308 0
+61 7 31762401
Fax 67308 0
Email 67308 0
marc.nickels@health.qld.gov.au

No information has been provided regarding IPD availability
Summary results
No Results