None listed
Conditions
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.
Interventions
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
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.
Sponsors
Marc Nickels
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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
Outcome results
None listed