Effect of Neurophysiological Facilitation Techniques in Intensive Care Patients

March 8, 2022 updated by: Mehmet Burak Uyaroğlu, Saglik Bilimleri Universitesi

Effect of Neurophysiological Facilitation Techniques on Functional Levels and Respiratory in Intensive Care Patients

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.

Study Overview

Detailed Description

The intensive care unit is a multidisciplinary unit in which patients with acute, life-threatening organ dysfunction or under risk are monitored and treated comprehensively. Advanced technology is used for follow-up and treatment in intensive care. These supports decrease the mortality rate. However, the increase length of stay in the ICU leads to higher hospital costs in addition to serious secondary pathologies. Prolonged immobilisation in the intensive care unit(ICU); causes the loss of muscle mass and strength of the patients. When the course of illness, the medical devices used, various medications, malnutrition and other reasons such as sepsis are accompanied by this immobilization, the disorder called Intensive Care Acquired Muscle Weakness (ICU-AW) occurs. This neuromuscular disorder, also causes functional impairments after ICU discharge.

Early physiotherapy intervention in ICU, has a positive effect on the symptoms frequently occur in patients. In addition to improve the functional status of the patient such as exercise capacity, muscle strength and mobilization, its increase weaning from mechanical ventilation, and decrease the length of stay in the ICU and hospital. It also provides airway clearance, reduction the work of breathing and improvement of respiratory function.

Neurophysiological facilitation of respiration is the use of proprioceptive and tactile stimulation that produce reflexive movement responses. These responses provide to increase the depth of breathing, decrease respiratory rate in patients with decreased level of consciousness. It also increase inspiratory expansion of the ribs, epigastric excursion and abdominal muscles tone. In the study conducted Kumar et al. has indicated that neurophysiological facilitation (NPF) techniques improves levels of dyspnea and oxygen saturation (spO2) in Coronavirus patients. It is very important to increase the level of oxygen saturation to rate the mortality. In NPF techniques, respectively the proprioceptors and tactile receptors in the abdominal, intercostals and spinal muscles are affected, phrenic motor neurons are stimulated, thoracic and abdominal excursions are increased and thus provide improves vital parameters.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey, 34010
        • Istinye University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Experimental Group
We applied neurophysiological facilitation techniques in addition to conventional rehabilitation.
Participants allocated to the experimental group completed until discharged, neurophysiological facilitation(NPF) techniques in addition to conventional physiotherapy.
Other Names:
  • Neurophysiological facilitation techniques in addition to conventional physiotherapy.
OTHER: Control Group
Critical ill patients was applied their conventional physiotherapy
Critical ill patients was applied their conventional physiotherapy which includes chest physiotherapy and mobilization until discharged
Other Names:
  • Conventional physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Chelsea Critical Care Physical Assessment Tool
Time Frame: through study completion, an average of 5 days
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
Time Frame: through study completion, an average of 5 days
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
Time Frame: through study completion, an average of 5 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Heart Rate
Time Frame: During ICU stay
Heart rate can be quantified easily at the bedside, while preload estimation has traditionally relied on invasive pressure measurements, both central venous and pulmonary artery wedge
During ICU stay
Change in Blood Pressure
Time Frame: During ICU stay
BP can be measured non-invasively using a sphygmomanometer (BP cuff).
During ICU stay
Change in Oxygen saturation
Time Frame: During ICU stay
Pulse oximetry is the technique used to measure arterial oxygen saturation in the peripheral blood vessels
During ICU stay
Change in Respiratory Frequency
Time Frame: During ICU stay
The respiratory frequency is usually measured when a person is at rest and simply involves counting the number of breaths for one minute by counting how many times the chest rises.
During ICU stay
Change in Perception of Fatigue
Time Frame: During ICU stay
the Perception of Fatigue is was assess to used The Borg Rating of Perceived Exertion(RPE). The Borg RPE scale is a numerical scale that ranges from 6 to 20, where 6 means "no fatigue at all" and 20 means "maximal fatigue.
During ICU stay
Change in Perception of Dyspnea
Time Frame: During ICU stay
the Perception of Dyspnea is was assess to used The Borg Rating of Perceived Exertion(RPE). The Borg RPE scale is a numerical scale that ranges from 6 to 20, where 6 means "no dyspnea at all" and 20 means "maximal dyspnea'.
During ICU stay
The Functional Independence Measure
Time Frame: through study completion, an average of 5 days
The The Functional Independence Measure (FIM) is an 18-item instrument measuring a person's level of disability in terms of burden of care. The FIM should be rated by the consensus opinion of a multidisciplinary team, but the evaluation is often performed by a single professional. Each item is rated from 1 (requiring total assistance) to 7 (completely independent). Three independent FIM scores can be generated by summing item scores: a total score (FIM total: 18 items), a motor score (FIM motor: eating, grooming, bathing, dressing - upper body, dressing - lower body, toileting, bladder management, bowel management, and transfers bed/chair/wheelchair, toilet, tub/shower, walk, stairs), and a cognitive score (FIM cognitive: auditory comprehension, verbal expression, social interaction, problem solving, and memory).
through study completion, an average of 5 days
Change in Muscle Strength
Time Frame: through study completion, an average of 5 days
Change in muscle strength was measured with a Digital Manual Muscle Tester.
through study completion, an average of 5 days
Change in Hand Grip Strength
Time Frame: through study completion, an average of 5 days
Change in Hand Grip Strength was measured with a Hydraulic Hand Dynamometer.
through study completion, an average of 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Mehmet Burak Uyaroğlu, PT,PhD, Saglik Bilimleri Universitesi
  • Principal Investigator: Yasemin Çırak, Ass.Prof, Istinye University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2019

Primary Completion (ACTUAL)

February 1, 2020

Study Completion (ACTUAL)

March 1, 2020

Study Registration Dates

First Submitted

February 26, 2022

First Submitted That Met QC Criteria

March 8, 2022

First Posted (ACTUAL)

March 16, 2022

Study Record Updates

Last Update Posted (ACTUAL)

March 16, 2022

Last Update Submitted That Met QC Criteria

March 8, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Saglik Bilimleri Uni

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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