Effect of Neurophysiological Facilitation Techniques in Intensive Care Patients
Primary Purpose
Intensive Care (ICU) Myopathy, Intensive Care Unit Acquired Weakness
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
NPF Group
Control Group
Sponsored by
About this trial
This is an interventional treatment trial for Intensive Care (ICU) Myopathy focused on measuring Intensive Care Unit, Critical Ill, Physiotherapy, Neurophysiologic Facilitation Techniques, Intensive Care Unit Acquired Weakness
Eligibility Criteria
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
Sites / Locations
- Istinye University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Experimental Group
Control Group
Arm Description
We applied neurophysiological facilitation techniques in addition to conventional rehabilitation.
Critical ill patients was applied their conventional physiotherapy
Outcomes
Primary Outcome Measures
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.
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.
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
Secondary Outcome Measures
Change in Heart Rate
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
Change in Blood Pressure
BP can be measured non-invasively using a sphygmomanometer (BP cuff).
Change in Oxygen saturation
Pulse oximetry is the technique used to measure arterial oxygen saturation in the peripheral blood vessels
Change in Respiratory Frequency
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.
Change in Perception of Fatigue
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.
Change in Perception of Dyspnea
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'.
The Functional Independence Measure
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).
Change in Muscle Strength
Change in muscle strength was measured with a Digital Manual Muscle Tester.
Change in Hand Grip Strength
Change in Hand Grip Strength was measured with a Hydraulic Hand Dynamometer.
Full Information
NCT ID
NCT05282576
First Posted
February 26, 2022
Last Updated
March 8, 2022
Sponsor
Saglik Bilimleri Universitesi
Collaborators
Medical Park Hospital Istanbul
1. Study Identification
Unique Protocol Identification Number
NCT05282576
Brief Title
Effect of Neurophysiological Facilitation Techniques in Intensive Care Patients
Official Title
Effect of Neurophysiological Facilitation Techniques on Functional Levels and Respiratory in Intensive Care Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
February 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saglik Bilimleri Universitesi
Collaborators
Medical Park Hospital Istanbul
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intensive Care (ICU) Myopathy, Intensive Care Unit Acquired Weakness
Keywords
Intensive Care Unit, Critical Ill, Physiotherapy, Neurophysiologic Facilitation Techniques, Intensive Care Unit Acquired Weakness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Active Comparator
Arm Description
We applied neurophysiological facilitation techniques in addition to conventional rehabilitation.
Arm Title
Control Group
Arm Type
Other
Arm Description
Critical ill patients was applied their conventional physiotherapy
Intervention Type
Other
Intervention Name(s)
NPF Group
Other Intervention Name(s)
Neurophysiological facilitation techniques in addition to conventional physiotherapy.
Intervention Description
Participants allocated to the experimental group completed until discharged, neurophysiological facilitation(NPF) techniques in addition to conventional physiotherapy.
Intervention Type
Other
Intervention Name(s)
Control Group
Other Intervention Name(s)
Conventional physiotherapy
Intervention Description
Critical ill patients was applied their conventional physiotherapy which includes chest physiotherapy and mobilization until discharged
Primary Outcome Measure Information:
Title
The Chelsea Critical Care Physical Assessment Tool
Description
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.
Time Frame
through study completion, an average of 5 days
Title
Physical Function in Intensive Care Test
Description
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.
Time Frame
through study completion, an average of 5 days
Title
Premorbid Level of Activity Scales
Description
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
Time Frame
through study completion, an average of 5 days
Secondary Outcome Measure Information:
Title
Change in Heart Rate
Description
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
Time Frame
During ICU stay
Title
Change in Blood Pressure
Description
BP can be measured non-invasively using a sphygmomanometer (BP cuff).
Time Frame
During ICU stay
Title
Change in Oxygen saturation
Description
Pulse oximetry is the technique used to measure arterial oxygen saturation in the peripheral blood vessels
Time Frame
During ICU stay
Title
Change in Respiratory Frequency
Description
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.
Time Frame
During ICU stay
Title
Change in Perception of Fatigue
Description
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.
Time Frame
During ICU stay
Title
Change in Perception of Dyspnea
Description
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'.
Time Frame
During ICU stay
Title
The Functional Independence Measure
Description
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).
Time Frame
through study completion, an average of 5 days
Title
Change in Muscle Strength
Description
Change in muscle strength was measured with a Digital Manual Muscle Tester.
Time Frame
through study completion, an average of 5 days
Title
Change in Hand Grip Strength
Description
Change in Hand Grip Strength was measured with a Hydraulic Hand Dynamometer.
Time Frame
through study completion, an average of 5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehmet Burak Uyaroğlu, PT,PhD
Organizational Affiliation
Saglik Bilimleri Universitesi
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yasemin Çırak, Ass.Prof
Organizational Affiliation
Istinye University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istinye University
City
Istanbul
ZIP/Postal Code
34010
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Neurophysiological Facilitation Techniques in Intensive Care Patients
We'll reach out to this number within 24 hrs