Early Cycloergometric Physiotherapy in Critically Ill Patients With Invasive Mechanical Ventilation

Hospital Son Llatzer

Status: Unknown

Conditions: Weakness

Treatments: Procedure: Conventional physiotherapy; Procedure: Cycle ergometer physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02478411

CYCLE-ICU-001

Details and patient eligibility

About

Study designed to evaluate the functional and motor effects in critically ill subjects at ICU and hospital discharge with the incorporation of a mobilization program of cycloergometric physiotherapy sessions compared with conventional physiotherapy.

Full description

Cycloergometric treatment is described to improve the functional and motor status of critically ill subjects. However, there are few studies comparing cycloergometric physiotherapy and conventional physiotherapy in intensive care subjects under mechanical ventilation. The most relevant of these studies conducted by Burtin et al showed beneficial effects of cycloergometric treatment. However, the duration of the physiotherapy sessions in this study differed between groups as cycloergometric group received a double daily dose of treatment. It is known that the intensity of physiotherapy also affects the functional and motor status.

For this reason, the investigators designed a randomized controlled study with early cycloergometric or conventional treatment, with the same intensity between groups to analyze objective functional and motor endpoints.

Enrollment: 68 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Criteria of functional independence before hospital admission (Barthel scale > 70 points).
• Invasive mechanical ventilation < 72 hours.
• Signed informed consent.

Exclusion criteria

• Neuromuscular disease (peripheric or central neurologic disorder).
• Presumed fatal evolution in 48 hours.
• Conditions that impede pedaling movement (leg, pelvis or lumbar spinal surgery or traumatism).
• Admission due to cardiac arrest.
• Pregnancy.
• Thrombopenia less than 50.000.
• Severe agitation.
• Hemodynamic instability with noradrenaline requirements greater than 1 mcg/kg/min.
• Fraction of inspired Oxygen (FiO2) requirements greater that 0.55 and respiratory rate greater than 30 bpm.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

68 participants in 2 patient groups

Cycle ergometer physiotherapy

Experimental group

Description:

15 minutes of cycle ergometer physiotherapy plus 15 minutes of conventional physiotherapy, once daily, five days a week, as long as patients remain in the intensive care unit

Treatment:

Procedure: Cycle ergometer physiotherapy

Conventional physiotherapy

Active Comparator group

Description:

30 minutes of conventional physiotherapy, once daily, five days a week, as long as patients remain in the intensive care unit

Treatment:

Procedure: Conventional physiotherapy