Critical IllnessNCT07361419
Metabolic Response to Supine Physiotherapy in Mechanically Ventilated ICU Patients
An observational study of Critical Illness and Mechanical Ventilation, run by Universidad de Extremadura at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Mechanical Ventilation, Intensive Care Unit-Acquired Weakness
- What is being tested?
- Supine Physiotherapy Session
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2026to 30 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult critically ill patients admitted to the intensive care unit who require invasive mechanical ventilation and receive routine supine physiotherapy as part of standard care. The study population includes both deeply sedated patients undergoing passive mobilization and awake or lightly sedated patients able to perform active-assisted mobilization, allowing characterization of metabolic responses across different levels of consciousness and participation.
Who may be able to join
- Adults aged 18 years or older.
- Admission to the intensive care unit.
- Invasive mechanical ventilation via endotracheal tube or tracheostomy.
- Ability to remain in the supine position during the measurement period.
- Clinical indication for supine physiotherapy as part of usual ICU care.
- Richmond Agitation-Sedation Scale (RASS) score between -5 and 0 at the time of the session.
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- Hemodynamic stability, defined as mean arterial pressure ≥65 mmHg with or without vasopressor support and no initiation or increase >20% in vasopressor dose within the previous 60 minutes.
- Respiratory stability, defined as no changes in ventilator settings within the previous 30 minutes and oxygen saturation ≥90% with FiO₂ ≤0.60 and PEEP ≤12 cmH₂O.
- Technical conditions allowing valid indirect calorimetry measurement (absence of significant air leaks and no planned circuit disconnections).
Who cannot join
- Use of extracorporeal membrane oxygenation (ECMO) or other extracorporeal gas exchange systems.
- Continuous renal replacement therapy during the measurement period when it may interfere with metabolic measurements.
- Significant air leaks in the airway or ventilator circuit that invalidate indirect calorimetry measurements.
- Planned procedures or interventions during the measurement period that could interfere with gas exchange (e.g., bronchoscopy, recruitment maneuvers, ventilator setting changes).
- Severe respiratory instability requiring FiO₂ >0.60 or PEEP >12 cmH₂O.
- Ongoing neuromuscular blockade infusion.
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- Clinical contraindications to limb mobilization (e.g., unstable fractures, active bleeding, uncontrolled intracranial hypertension).
- Agitation or risk of unplanned device removal (RASS >0).
- Refusal of participation by the patient or legally authorized representative, when applicable.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metabolic Response to Supine Physiotherapy in Mechanically Ventilated Critically Ill Patients Assessed by Indirect Calorimetry
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.
Read more
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.
- Conditions
- Critical Illness, Mechanical Ventilation, Intensive Care Unit-Acquired Weakness, Physical Rehabilitation in the Intensive Care Unit
- Being tested
- Supine Physiotherapy Session
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supine Physiotherapy SessionProcedure or surgery
Adult critically ill patients receiving invasive mechanical ventilation who undergo passive supine physiotherapy as part of usual intensive care unit care. Physiotherapy consists exclusively of passive limb mobilization performed by a physiotherapist, with no voluntary muscle activation by the patient, and is applied in deeply sedated patients.
| Study group | Role | What they receive |
|---|---|---|
| Passive Supine Physiotherapy | Adult critically ill patients receiving invasive mechanical ventilation who undergo standardized passive supine physiotherapy as part of usual ICU care. During the physiotherapy session, oxygen consumption is continuously measured using indirect calorimetry integrated into the ventilator, including baseline rest, intervention, and recovery periods. Receives: Procedure: Supine Physiotherapy Session | |
| Active-Assisted Supine Physiotherapy | Adult critically ill patients receiving invasive mechanical ventilation who undergo active-assisted supine physiotherapy as part of usual intensive care unit care. Physiotherapy consists of active-assisted limb mobilization, in which the patient voluntarily initiates the movement and the physiotherapist provides assistance as needed to complete the range of motion. This intervention is applied in patients who are awake or lightly sedated and able to cooperate. Receives: Procedure: Supine Physiotherapy Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oxygen Consumption (ΔVO₂) During Supine Physiotherapy
Oxygen consumption (VO₂) will be continuously measured using indirect calorimetry integrated into the mechanical ventilator during a standardized supine physiotherapy session performed as part of usual ICU care. The primary outcome is the change in VO₂ (ΔVO₂), defined as the difference between mean VO₂ during the physiotherapy intervention and mean VO₂ during a preceding baseline resting period, within the same session. Each participant serves as their own control.
Measured: During a single physiotherapy session (baseline rest and intervention periods).
Secondary outcomes (7)
Total Metabolic Load of the Physiotherapy Session (VO₂ Area Under the Curve Above Baseline)
Oxygen consumption (VO₂) will be continuously measured by indirect calorimetry during baseline rest, the physiotherapy intervention, and the recovery period. Total metabolic load will be expressed as the area under the VO₂-time curve above baseline (AUC above baseline), integrating the excess VO₂ over time attributable to the session.
Measured: During a single physiotherapy session (baseline, intervention, and recovery periods)
Peak Oxygen Consumption During Supine Physiotherapy
Peak VO₂ will be defined as the highest VO₂ value observed during the physiotherapy intervention period, measured continuously via indirect calorimetry. The outcome will be reported as the absolute peak VO₂ and may be expressed relative to baseline.
Measured: During the physiotherapy intervention period of a single session
Relative Change in Oxygen Consumption During Supine Physiotherapy (%ΔVO₂)
The relative change in oxygen consumption will be calculated as the percentage difference between mean VO₂ during the physiotherapy intervention and mean VO₂ during baseline rest within the same session.
Measured: During a single physiotherapy session (baseline rest and intervention periods).
Time to Recovery of Oxygen Consumption Toward Baseline After Physiotherapy
Recovery time will be defined as the time required after the end of the physiotherapy intervention for VO₂ to return to within ±10% of the baseline mean value and remain within that range for a sustained period (as per protocol). If VO₂ does not return to this range within the maximum monitoring window, recovery will be recorded as not achieved within the session.
Measured: Immediately after the physiotherapy intervention, up to the end of the recovery monitoring period within a single session.
Cardiorespiratory Stability During Supine Physiotherapy
Physiological stability during the session will be assessed by changes from baseline in heart rate, blood pressure (including mean arterial pressure), peripheral oxygen saturation (SpO₂), and ventilatory parameters recorded during baseline rest, intervention, and recovery. Clinically relevant events leading to interruption of the session (e.g., desaturation, hypotension, arrhythmia) will be documented.
Measured: During a single physiotherapy session (baseline, intervention, and recovery periods).
Carbon Dioxide Production (VCO₂) and Respiratory Exchange Ratio (RER) During Supine Physiotherapy
Carbon dioxide production (VCO₂) will be continuously measured by indirect calorimetry during baseline rest, intervention, and recovery. Respiratory exchange ratio (RER) will be calculated as VCO₂/VO₂ for the same periods to describe metabolic response patterns.
Measured: During a single physiotherapy session (baseline, intervention, and recovery periods).
Energy Expenditure During Supine Physiotherapy
Energy expenditure will be estimated from VO₂ and VCO₂ as provided by the indirect calorimetry system. Values will be summarized for baseline rest, the physiotherapy intervention, and the recovery period within the same session.
Measured: During a single physiotherapy session (baseline, intervention, and recovery periods).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start1 Feb 2026
- Primary completion30 May 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Fernández-Morales, Universidad de Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07361419
- Sponsor's protocol ID
- 12
- Status last verified
- Mar 2026
- First submitted
- 14 Jan 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Response to Supine Physiotherapy in Mechanically Ventilated Critically Ill Patients Assessed by Indirect Calorimetry
- ClinicalTrials.gov ID
- NCT07361419
- Acronym / sponsor ID
- 12
- Conditions
- Critical Illness, Mechanical Ventilation, Intensive Care Unit-Acquired Weakness, Physical Rehabilitation in the Intensive Care Unit
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidad de ExtremaduraUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Passive Supine Physiotherapy | – | Procedure: Supine Physiotherapy SessionAdult critically ill patients receiving invasive mechanical ventilation who undergo standardized passive supine physiotherapy as part of usual ICU care. During the physiotherapy session, oxygen consumption is continuously measured using indirect calorimetry integrated into the ventilator, including baseline rest, intervention, and recovery periods. |
| Active-Assisted Supine Physiotherapy | – | Procedure: Supine Physiotherapy SessionAdult critically ill patients receiving invasive mechanical ventilation who undergo active-assisted supine physiotherapy as part of usual intensive care unit care. Physiotherapy consists of active-assisted limb mobilization, in which the patient voluntarily initiates the movement and the physiotherapist provides assistance as needed to complete the range of motion. This intervention is applied in patients who are awake or lightly sedated and able to cooperate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult critically ill patients admitted to the intensive care unit who require invasive mechanical ventilation and receive routine supine physiotherapy as part of standard care. The study population includes both deeply sedated patients undergoing passive mobilization and awake or lightly sedated patients able to perform active-assisted mobilization, allowing characterization of metabolic responses across different levels of consciousness and participation.
Key inclusion criteria (9 listed)
- Adults aged 18 years or older.
- Admission to the intensive care unit.
- Invasive mechanical ventilation via endotracheal tube or tracheostomy.
- Ability to remain in the supine position during the measurement period.
- Clinical indication for supine physiotherapy as part of usual ICU care.
Key exclusion criteria (9 listed)
- Use of extracorporeal membrane oxygenation (ECMO) or other extracorporeal gas exchange systems.
- Continuous renal replacement therapy during the measurement period when it may interfere with metabolic measurements.
- Significant air leaks in the airway or ventilator circuit that invalidate indirect calorimetry measurements.
- Planned procedures or interventions during the measurement period that could interfere with gas exchange (e.g., bronchoscopy, recruitment maneuvers, ventilator setting changes).
- Severe respiratory instability requiring FiO₂ >0.60 or PEEP >12 cmH₂O.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supine Physiotherapy SessionAdult critically ill patients receiving invasive mechanical ventilation who undergo passive supine physiotherapy as part of usual intensive care unit care. Physiotherapy consists exclusively of passive limb mobilization performed by a physiotherapist, with no voluntary muscle activation by the patient, and is applied in deeply sedated patients. | Procedure or surgery | Active-Assisted Supine Physiotherapy, Passive Supine Physiotherapy |
Primary outcome
Change in Oxygen Consumption (ΔVO₂) During Supine Physiotherapy
Time frame: During a single physiotherapy session (baseline rest and intervention periods).
Oxygen consumption (VO₂) will be continuously measured using indirect calorimetry integrated into the mechanical ventilator during a standardized supine physiotherapy session performed as part of usual ICU care. The primary outcome is the change in VO₂ (ΔVO₂), defined as the difference between mean VO₂ during the physiotherapy intervention and mean VO₂ during a preceding baseline resting period, within the same session. Each participant serves as their own control.
7 secondary outcomes
Total Metabolic Load of the Physiotherapy Session (VO₂ Area Under the Curve Above Baseline)
Time frame: During a single physiotherapy session (baseline, intervention, and recovery periods)
Peak Oxygen Consumption During Supine Physiotherapy
Time frame: During the physiotherapy intervention period of a single session
Relative Change in Oxygen Consumption During Supine Physiotherapy (%ΔVO₂)
Time frame: During a single physiotherapy session (baseline rest and intervention periods).
Time to Recovery of Oxygen Consumption Toward Baseline After Physiotherapy
Time frame: Immediately after the physiotherapy intervention, up to the end of the recovery monitoring period within a single session.
Cardiorespiratory Stability During Supine Physiotherapy
Time frame: During a single physiotherapy session (baseline, intervention, and recovery periods).
Carbon Dioxide Production (VCO₂) and Respiratory Exchange Ratio (RER) During Supine Physiotherapy
Time frame: During a single physiotherapy session (baseline, intervention, and recovery periods).
Energy Expenditure During Supine Physiotherapy
Time frame: During a single physiotherapy session (baseline, intervention, and recovery periods).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Mechanical Ventilation, run by Universidad de Extremadura at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oxygen Consumption (ΔVO₂) During Supine Physiotherapy (time frame: During a single physiotherapy session (baseline rest and intervention periods).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.