Clinical Trial

Metabolic Response to Supine Physiotherapy in Mechanically Ventilated ICU Patients

Active, Not Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated March 19, 2026 (before its estimated May 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
Critically ill patients who require mechanical ventilation frequently experience rapid loss of muscle mass and physical function during their stay in the intensive care unit (ICU). As part of standard care, physiotherapy and limb mobilization exercises are commonly provided, even in patients who are sedated and confined to bed in a supine position. However, the actual physiological and metabolic intensity of these routine physiotherapy interventions is poorly understood, and current prescriptions are largely based on clinical judgment rather than objective measures of patient effort or tolerance. Oxygen consumption (VO₂) is a direct indicator of metabolic demand and physiological workload. In mechanically ventilated patients, indirect calorimetry integrated into the ventilator allows continuous measurement of VO₂ and carbon dioxide production without adding invasive procedures. While indirect calorimetry is routinely used to individualize nutritional support in the ICU, its potential role in quantifying the metabolic cost of physiotherapy interventions has been scarcely explored. The aim of this prospective observational study is to quantify the acute metabolic response to a standardized session of supine physiotherapy in adult critically ill patients receiving invasive mechanical ventilation. During routine physiotherapy sessions performed as part of usual care, oxygen consumption will be continuously measured using indirect calorimetry integrated into the ventilator circuit. Each session will include a baseline resting period, the physiotherapy intervention itself, and a post-intervention recovery period, allowing patients to act as their own controls. Physiotherapy sessions will consist of passive limb mobilization in deeply sedated patients and passive or active-assisted mobilization in patients who are awake or lightly sedated and able to cooperate. The primary outcome will be the change in oxygen consumption during physiotherapy compared with baseline rest. Secondary analyses will describe the total metabolic load of the session, peak oxygen consumption, and the time required for oxygen consumption to return toward baseline levels after the intervention. Basic cardiorespiratory variables, such as heart rate, blood pressure, oxygen saturation, and ventilatory parameters, will also be recorded to assess physiological stability and tolerance. By objectively characterizing the metabolic cost of common supine physiotherapy interventions, this study aims to improve understanding of the physiological demands imposed on mechanically ventilated ICU patients. The results may help inform safer and more individualized physiotherapy prescriptions in critical care, supporting a more objective approach to dosing rehabilitation based on patients' real metabolic responses rather than solely on activity type or sedation level.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2026-01-14; most recent amendment 2026-03-18.
Status change: Not Yet Recruiting → Active, Not Recruiting 2026-03-16
Trial Details
NCT Number NCT07361419
Lead Sponsor Universidad de Extremadura
Conditions Critical Illness, Mechanical Ventilation, Intensive Care Unit-Acquired Weakness, Physical Rehabilitation in the Intensive Care Unit
Enrollment 40 participants
Start Date 2026-02-01
Primary Completion 2026-05-30 (estimated)
Study Completion 2026-05-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-19