Cycling Exercise in Mechanical Ventilation

Study Overview
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Brief Summary
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Prolonged critical illness renders survivors with increased long-term morbidity associated with high healthcare costs. Muscle weakness and fatigue are reported as the main contributors to long-term poor functional outcomes. Emerging evidence for early mobilisation demonstrates reduction in the number of ventilator days and hospital length of stay. It has been demonstrated that daytime motoring (passive and active) can improve functional capacity in intensive care patients. The aim of the proposed study is to evaluate the effect of cycling exercise in patients on mechanical ventilation appointed to weaning process.

Detailed Description
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This prospective randomized study is being performed at the Department of Anesthesiology, Resuscitation and Intensive Care (CARIM) of the University Hospital Ostrava. All mechanically ventilated patients are followed. At the time of weaning initiation, the randomization into two groups (the study (cycling) and control group) is performed. The physiotherapy will be carried out twice a day in both groups according to the mobility protocol. The cycling exercise is performed only in the study group, once a day. Before a patient is released from the ICU, a cycling test, dynamometry test will be performed on both groups.

Official Title
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Effect of a Cycling Exercise on Restoration of Muscle Strength in Patients Undergoing Mechanical Ventilation

Conditions
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Muscle Weakness, Mechanical Ventilation Complication

Intervention / Treatment
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* Other: Cycling Exercise
* Other: Conventional Physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years ICU admission Mechanically ventilated for more than 5 days Indications for starting weaning Informed consent for participation Exclusion Criteria: Inability to use cycling exercise: trauma or operation of lower limbs, pelvis, open abdomen, non-cooperation (qualitative and quantitative disturbance of consciousness) Encephalopathy (ischemic, traumatic) Extreme obesity (body mass index ≥ 40) Anticipated survival time ≤ 7 days Patient height ≤ 1.5 m More than 48 hours of mechanical ventilation outside of the department

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients enrolled in the study will be randomized into two groups - active intervention and control group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cycling Exercise<br>Patients randomized into this arm will undergo cycling exercise once a day while on mechanical ventilation at intensive care unit. | Other: Cycling Exercise<br>* Cycling exercise will be performed in the patients once a day.<br>Other: Conventional Physiotherapy<br>* Conventional physiotherapy will be performed in the patients twice a day.<br>|
| Active Comparator: Conventional Physiotherapy<br>Patients randomized into this arm will undergo conventional physiotherapy twice a day while on mechanical ventilation at intensive care unit. | Other: Conventional Physiotherapy<br>* Conventional physiotherapy will be performed in the patients twice a day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of ventilator days | The influence of cycling exercises on the number of ventilator days will be assessed in the patients. The number of ventilator days will be compared in both groups of patients. | 43 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength | Muscle strength will be assessed in the mechanically ventilated patients in both groups on the Medical Research Council Manual Muscle Testing scale. This muscle scale grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle; the higher the measured value, the bigger the muscle strength and vice versa. | 43 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cycling exercise, mechanically ventilated patient, muscle strength assessment, muscle weakness