Effect of Neurophysiological Facilitation Techniques in Intensive Care Patients

NCT05282576 | Completed

• 1 other identifier: Saglik Bilimleri Uni
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to investigate the effect of neurophysiological facilitation techniques on respiratory and functional levels in intensive care patients. Participants were divided into two groups as experimental (n=20) and control (n=20). Conventional physiotherapy, which includes chest physiotherapy, mobilization exercises and range of motion exercises were applied in control group. Neurophysiological facilitation techniques in addition to the conventional physiotherapy program ere applied in experimental group. The functional status, lower and upper extremity muscle strength, grip strength measurements of the patients and the rates of weaning from mechanical ventilation were evaluated before and after treatment. Vital signs, dyspnea and fatigue perception were assessed each day of treatment. Evaluations were analyzed statistically using Statistical Package for the Social Sciences-22 program.

Conditions

Intensive Care (ICU) Myopathy; Intensive Care Unit Acquired Weakness

Keywords

Intensive Care Unit; Critical Ill; Physiotherapy; Neurophysiologic Facilitation Techniques; Intensive Care Unit Acquired Weakness

Outcome Measures

Primary Outcomes (3)

• The Chelsea Critical Care Physical Assessment Tool

  The Chelsea Critical Care Physical Assessment Tool (CPAx) is a test used on male and female patients in the intensive care unit (ICU) to assess physical and respiratory function impairments and morbidity. The CPAx assessment also identifies patients at risk for developing ICU-acquired complications, such as weakness and mobility decline. The CPAx assesses 10 domains including respiratory function, cough, bed mobility, supine to sitting on edge of bed, dynamic sitting, standing balance, sit to stand, transferring bed to chair, stepping, and grip strength.

  through study completion, an average of 5 days

• Physical Function in Intensive Care Test

  Physical Function in Intensive Care Test(PFIT) is specifically for the patient population in the intensive care unit (ICU) who are critically ill. This test can be used to guide exercise prescription within the ICU as well as measure functional recovery. The PFIT-s is a battery outcome measure involving four components: sit to stand assistance, marching on the spot cadence, shoulder flexor and knee extensor strength. The PFIT include 4 items.

  through study completion, an average of 5 days

• Premorbid Level of Activity Scales

  Premorbid dyspnea was scored according to the American Thoracic Society (ATS) scale. The activities of daily living were recorded as 0 = working; 1 = independent (fully ambulatory and living without any assistance); 2 = restricted (able to live on their own and leave their homes to perform basic tasks, but severally limited in exercise ability); 3 = housebound (cannot leave their homes unassisted or leave their homes rarely, able to perform self-care but unable to do heavy chores such as house cleaning, cannot live alone, and may be institutionalized; and 4 = bedridden or wheelchair-bound

  through study completion, an average of 5 days

Secondary Outcomes (9)

• Change in Heart Rate

  During ICU stay

• Change in Blood Pressure

  During ICU stay

• Change in Oxygen saturation

  During ICU stay

• Change in Respiratory Frequency

  During ICU stay

• Change in Perception of Fatigue

  During ICU stay

Study Arms (2)

Experimental Group

ACTIVE COMPARATOR

We applied neurophysiological facilitation techniques in addition to conventional rehabilitation.

Other: NPF Group

Control Group

OTHER

Critical ill patients was applied their conventional physiotherapy

Other: Control Group

Interventions

NPF Group OTHER

Participants allocated to the experimental group completed until discharged, neurophysiological facilitation(NPF) techniques in addition to conventional physiotherapy.

Also known as: Neurophysiological facilitation techniques in addition to conventional physiotherapy.

Experimental Group

Control Group OTHER

Critical ill patients was applied their conventional physiotherapy which includes chest physiotherapy and mobilization until discharged

Also known as: Conventional physiotherapy

Control Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically Unstable
• Participants Over the Age of 18
• Individuals who volunteered to participate in the study or were allowed by their first-degree relatives if they were unconscious.
• Patients who are suitable for physiotherapy by the intensive care specialist.

You may not qualify if:

• Having coagulation disorder (INR \> 1,5 platelet\<50.000 mm3)
• Having neuromuscular diseases
• Having psychiatric disease or overly agitated (Richmond Agitation Sedation Scale score ≥ +2)
• Having acute stroke
• Having Raised Intracranial Pressure Syndrome symptoms
• Having cardiac and respiratory instability (Respiratory frequency \> 30 breaths/min,Partial pressure of oxygen(PaO₂)\< 65 mmHg , fraction of inspired oxygen(FiO₂)\>%55, Diastolic blood pressure \< 50 mmHg or \> 200 mmHg , Systolic blood pressure \< 80 mmHg or \> 200 mmHg)
• Having hemodynamic instability (intropin dose \> 5 mcg/kg/min)
• Fever
• Malignity
• Shock
• Patients admitted to ICU after cardiac, trauma and surgery

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead
• Medical Park Hospital Istanbul: collaborator

Study Sites (1)

Istinye University

Istanbul, 34010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Muscular Diseases

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Mehmet Burak Uyaroğlu, PT,PhD

  Saglik Bilimleri Universitesi

  STUDY DIRECTOR

• Yasemin Çırak, Ass.Prof

  Istinye University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 26, 2022
• First Posted: March 16, 2022
• Study Start: October 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: March 1, 2020
• Last Updated: March 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)