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Improving Outcomes in Critical Illness with Early Rehabilitation

Mobilising Critically Ill patients: Physiological and Functional Outcomes following Early Rehabilitation in Sepsis

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000808044
Acronym
i-PERFORM Trial
Enrollment
50
Registered
2010-09-27
Start date
2010-10-31
Completion date
2012-12-31
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Admission to an intensive care unit occurs due to the either major trauma or critical illness. Approximately 12% of admissions to intensive care unit (ICU) are for sepsis and a further 20% will develop sepsis, which has major immediate and long term effects on morbidity and mortality. If the patient survives the initial illness, a combination of the detrimental effects of the major illness stress response, nutrition, glucose levels, inflammatory mediators, immobility, hospital acquired infections and certain pharmacological agents can result in the loss of large amounts of muscle mass attributed to a proteolytic or protein degradation process or specific critical care weakness syndromes. This all results in further inability to sit, walk, swallow and breathe and a decrease in endurance in respiratory muscles, necessitating a longer time on the ventilator, increased stay in ICU, increased potential for nosocomial infection and subsequent increased morbidity and mortality. These patients are frequently depressed and anxious which has been shown to be associated with an inability to wean from the ventilator and be readmitted to intensive care when eventually discharged. Readmission will result in a further increase in morbidity and mortality. Combined, these factors escalate health care resource use during and beyond the initial hospital stay. Studies investigating the quality of life of critically ill patients on discharge from hospital have found severe psychological and physical problems. Overall ICU survivors have been found to have a lower health related quality of life. ICU patients specifically with sepsis can have a worse outcome. Preliminary evidence suggests that simple physical interventions may prevent detrimental effects of intensive care stay. Muscle stretch and passive movement can decrease levels of inflammatory markers. These indicate there is potential to prevent protein degradation and loss of muscle mass. Oxidative stress which refers to stress of any kind, in the event of limited oxygen supply, is known to induce inflammatory responses and destroy cells in critically ill patients that can lead to an increased mortality rate. In trying to prevent oxidative stress, many critically ill patients are not mobilised in the early stages of ICU admission which contributes to loss of muscle mass and decline in functional ability upon ICU discharge. During rehabilitation in the ICU, it is hard to predict the level of exhaustion or fatigue the intensity of the exercise induces on the patients. There has been some evidence to support that both locomotive and breathing muscles in sepsis show dramatic decreases in mitochondrial content, causing an acute lack of energy when the muscle is activated again following discharge. This highlights the importance of maintaining the use of respiratory and skeletal muscles during the disease process. In surviving septic patients, energy expansion is limited and exhaustive exercise can worsen this condition. Patients with sepsis demonstrate high levels of lactate in the blood which can cause fatigue. Understanding the effects of acute exercise on lactate levels in septic patients can help predict a safe rehabilitation scope. Early use of skeletal muscles can contribute to lactate clearance. Regular low intensity exercise training can also increase the rate of lactate clearance . This suggests there is potential that low intensity exercise can control lactate levels and even help reduce it. This study will investigate the associations between early rehabilitation and fatigue. When a patient initially develops sepsis it is recommended that they do not receive physiotherapy intervention (even passive movements) as it is believed that during an inflammatory process they are too unstable. Some ICU's do not include rehabilitation either in the belief it is unsafe or due to insufficient staffing levels. This study will determine whether early rehabilitation for septic patients with sepsis in ICU is clinically effective and appropriate. It will provide insight and evidence on physiological outcomes that will determine the safety of early mobilisation in critically ill patients. With evidence for early targeted rehabilitation in the ICU, there can be facilitated early functional recovery in the critically ill patients and decreased stay in the ICU.

Interventions

Intervention Arm: Adminster Rehabiliation package ( targeted exercises) by physiotherapist in the intensive care unit (ICU). The intervention group will receive an early, specific, targeted rehabilitation program involving electrical muscle stimulation, passive and active range of motion exercises, mobilisation out of bed, tilt-table therapy, arm and leg ergometry exercises and ambulation. Commencement: 48hrs following Mechanical Ventilation Duration and Frequency: 30 mins x 1-2 day Overall

Intervention Arm: Adminster Rehabiliation package ( targeted exercises) by physiotherapist in the intensive care unit (ICU). The intervention group will receive an early, specific, targeted rehabilitation program involving electrical muscle stimulation, passive and active range of motion exercises, mobilisation out of bed, tilt-table therapy, arm and leg ergometry exercises and ambulation. Commencement: 48hrs following Mechanical Ventilation Duration and Frequency: 30 mins x 1-2 day Overall duration: From recruitment till ICU discharge Mode of adminstration: Individual exercise prescription by a physiotherapist

Sponsors

Ms Geetha Kayambu
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Acutely ill patients who are mechanically ventilated for longer than 48 hours with documented sepsis or those with strong clinical suspicion of possible sepsis

Exclusion criteria

Patients with head injuries, burns, spinal injuries, multiple fractured lower limbs and acute coronary syndrome

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 28, 2026