Effect of Physiotherapy Methods on Functional and Respiratory Outcomes in ICU Patients With Respiratory Failure

Changes in Functional and Qualitative Indicators of Critically Ill Patients With Respiratory Failure Using Different Physiotherapy Methods

The aim of the biomedical study is to assess the changes in functional and qualitative indicators of critically ill patients with respiratory failure by applying different physiotherapy methods. By conducting this study and developing the "Physiotherapy Protocol for Critically Ill Patients Treated in the ICU," physiotherapists worldwide could be encouraged to work using a unified and adapted method.

It is expected that the results, conclusions, and practical clinical recommendations derived from this study will be beneficial not only for rehabilitation specialists and intensivists in Lithuania but also for medical professionals working with respiratory diseases, including COVID-19 patients, at various stages of their treatment and consultation.

Implementing an appropriate physiotherapy procedure protocol is anticipated to bring economic benefits, as early physiotherapy is safe and can reduce the incidence of delirium, decrease the duration of patient sedation, shorten the number of days on mechanical ventilation, and minimize hospital stay duration. Additionally, it aims to restore or improve patients' functional and independence levels, help prevent ICU-acquired weakness, and can be easily implemented in intensive care units.

Study Overview

• Status: Active, not recruiting
• Conditions: Respiratory Insufficiency
• Intervention / Treatment: Other: Active Physiotherapy; Other: Passive Physiotherapy

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lithuania
  • Kaunas, Lithuania, 49217
    • Lithuanian University of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults (≥18 years of age)
• Hospitalized in the Department of Reanimation and Intensive Therapy at LSMU Kaunas Clinics
• Diagnosis of respiratory failure (KFN) based on the following TLK-10-AM codes: J96.00, J96.01, J96.9, J96.10, J96.11, J96.19, J96.90, J96.91, J96.99
• Signed informed consent obtained from the patient or their legal representative

Exclusion Criteria:

• Conscious patients who refuse to participate in the study
• Unconscious patients whose legal representative does not consent
• Recent episode of myocardial ischemia
• Pregnancy
• Heart rate < 40 bpm or > 130 bpm
• Mean arterial pressure < 60 mmHg or > 110 mmHg
• Oxygen saturation (SpO₂) ≤ 85%
• Body temperature ≥ 38.5°C or ≤ 36.0°C

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Physiotherapy Intervention Arm (n=75); The subjects of one group will receive active physiotherapy (eg: verticalization, sitting on the edge of the bed, active breathing exercises).	Other: Active Physiotherapy; Involves patient-driven exercises such as verticalization, sitting on the edge of the bed, and active breathing exercises.
Experimental: Passive Physiotherapy Intervention Arm (n=75); The other group will receive passive physiotherapy methods (eg: passive movements, electrostimulation of the diaphragm).	Other: Passive Physiotherapy; Employs methods like passive movements and electrostimulation of the diaphragm, providing therapeutic benefits without requiring active patient engagement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1) from baseline to ICU discharge	Pulmonary function will be assessed using spirometry. The following parameters will be measured in liters and as percentages of predicted values: Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 second (FEV1). Measurements will be taken on Day 1 (baseline) and at ICU discharge. The mean change in FVC and FEV1 will be calculated to assess respiratory improvement.	From Day 1 of ICU admission to ICU discharge (up to 50 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Arterial Oxygenation Parameters (PaO₂, FiO₂, and PaO₂/FiO₂ Ratio) During ICU Stay	Arterial blood gas analysis will be performed to monitor oxygenation. The following parameters will be recorded daily: arterial oxygen partial pressure (PaO₂, mmHg), inspired oxygen fraction (FiO₂), and their ratio (PaO₂/FiO₂). These values will be used to assess the progression of respiratory function and severity of respiratory failure. Mean changes from baseline to ICU discharge will be analyzed.	From Day 1 of ICU admission to ICU discharge (up to 50 days)
Change in Heart Rate and Arterial Blood Pressure Before and After Physiotherapy Session	Heart rate (beats per minute) and arterial blood pressure (systolic and diastolic, mmHg) will be measured immediately before and after each physiotherapy session to evaluate acute cardiovascular responses. Data will be recorded daily throughout the ICU stay (up to 50 days). Mean changes will be analyzed.	Immediately before and immediately after each physiotherapy session, up to 50 days during ICU stay
Change in Intensive Care Unit Mobility Scale (ICUMS) Scores During ICU Stay	Patient mobility will be evaluated using the Intensive Care Unit Mobility Scale (ICUMS), which scores mobility from 0 (passive movements only) to 10 (independent ambulation). The scale will be administered at the beginning of each physiotherapy session. Mean score progression over time will be used to assess functional mobility changes.	From Day 1 of physiotherapy to ICU discharge (up to 50 days)

Collaborators and Investigators

• Sponsor: Laura Rutkauskienė
• Collaborators: Lithuanian University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: March 16, 2025
• First Submitted That Met QC Criteria: March 30, 2025
• First Posted (Actual): April 4, 2025

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: Protocol number 1 • Version 3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: For now, we do not have enough human and financial resources to share IPD, but if our circumstances change, we are open to reconsidering this decision.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No