Cycling Exercise in Mechanical Ventilation

Not Applicable

Completed

• Conditions: Mechanical Ventilation Complication; Muscle Weakness
• Interventions: Other: Cycling Exercise; Other: Conventional Physiotherapy

• Registration Number: NCT03581760
• Lead Sponsor: University Hospital Ostrava

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-05-02
• Study First Submitted: 2018-06-12
• Study First Submitted QC: 2018-06-26
• Study First Posted: 2018-07-10
• Primary Completion: 2020-11-30
• Study Completion: 2020-12-31
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-06
• Last Update Posted: 2022-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cycling Exercise	Cycling Exercise	Patients randomized into this arm will undergo cycling exercise once a day while on mechanical ventilation at intensive care unit.
Cycling Exercise	Conventional Physiotherapy	Patients randomized into this arm will undergo cycling exercise once a day while on mechanical ventilation at intensive care unit.
Conventional Physiotherapy	Conventional Physiotherapy	Patients randomized into this arm will undergo conventional physiotherapy twice a day while on mechanical ventilation at intensive care unit.

Primary Outcome Measures

Name	Time	Method
Number of ventilator days	43 months	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.

Secondary Outcome Measures

Name	Time	Method
Muscle strength	43 months	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.

Trial Locations

Locations (1)

University Hospital Ostrava; 🇨🇿 Ostrava, Moravian-Silesian Region, Czechia