Cycling Exercise in Mechanical Ventilation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-02

Study Completion Date

2020-12-31

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.

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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.

Conditions

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Muscle Weakness Mechanical Ventilation Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients enrolled in the study will be randomized into two groups - active intervention and control group.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

This is an open-label study, no masking model is applied.

Study Groups

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Cycling Exercise

Patients randomized into this arm will undergo cycling exercise once a day while on mechanical ventilation at intensive care unit.

Group Type EXPERIMENTAL

Cycling Exercise

Intervention Type OTHER

Cycling exercise will be performed in the patients once a day.

Conventional Physiotherapy

Intervention Type OTHER

Conventional physiotherapy will be performed in the patients twice a day.

Conventional Physiotherapy

Patients randomized into this arm will undergo conventional physiotherapy twice a day while on mechanical ventilation at intensive care unit.

Group Type ACTIVE_COMPARATOR

Conventional Physiotherapy

Intervention Type OTHER

Conventional physiotherapy will be performed in the patients twice a day.

Interventions

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Cycling Exercise

Cycling exercise will be performed in the patients once a day.

Intervention Type OTHER

Conventional Physiotherapy

Conventional physiotherapy will be performed in the patients twice a day.

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No