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

NCT06912308 | Active Not Recruiting DMC

• 1 other identifier: Protocol number 1 • Version 3
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiratory Insufficiency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Arterial Oxygenation Parameters (PaO₂, FiO₂, and PaO₂/FiO₂ Ratio) During ICU Stay

  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

  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

  From Day 1 of physiotherapy to ICU discharge (up to 50 days)

Study Arms (2)

Active Physiotherapy Intervention Arm (n=75)

EXPERIMENTAL

The subjects of one group will receive active physiotherapy (eg: verticalization, sitting on the edge of the bed, active breathing exercises).

Other: Active Physiotherapy

Passive Physiotherapy Intervention Arm (n=75)

EXPERIMENTAL

The other group will receive passive physiotherapy methods (eg: passive movements, electrostimulation of the diaphragm).

Other: Passive Physiotherapy

Interventions

Active Physiotherapy OTHER

Involves patient-driven exercises such as verticalization, sitting on the edge of the bed, and active breathing exercises.

Active Physiotherapy Intervention Arm (n=75)

Passive Physiotherapy OTHER

Employs methods like passive movements and electrostimulation of the diaphragm, providing therapeutic benefits without requiring active patient engagement.

Passive Physiotherapy Intervention Arm (n=75)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laura Rutkauskienė: lead
• Lithuanian University of Health Sciences: collaborator

Study Sites (1)

Lithuanian University of Health Sciences

Kaunas, 49217, Lithuania

Location

Related Publications (1)

• Rutkauskiene L, Kubilius R, Tamosuitis T. Early mobilization, breathing exercises and chest wall oscillation in patients with bilateral pneumonia disease in the intensive care unit: a randomized clinical trial. BMC Pulm Med. 2025 Nov 25;26(1):20. doi: 10.1186/s12890-025-04028-7.

  PMID: 41286729 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Researcher

Study Record Dates

• First Submitted: March 16, 2025
• First Posted: April 4, 2025
• Study Start: September 30, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: April 9, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)