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

NCT ID: NCT06912308

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-30
• Study Completion Date: 2027-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Active Physiotherapy

Intervention Type: OTHER

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

Passive Physiotherapy Intervention Arm (n=75)

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

Group Type: EXPERIMENTAL

Passive Physiotherapy

Intervention Type: OTHER

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

Interventions

Active Physiotherapy

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

Intervention Type: OTHER

Passive Physiotherapy

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lithuanian University of Health Sciences

OTHER

Sponsor Role: collaborator

Laura Rutkauskienė

OTHER

Sponsor Role: lead

Responsible Party

Laura Rutkauskienė

Clinical Researcher

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Lithuanian University of Health Sciences

Kaunas, , Lithuania

Countries

Lithuania

Other Identifiers

Protocol number 1 • Version 3

Identifier Type: -

Identifier Source: org_study_id