Intensive Care (ICU) MyopathyNCT05282576
Effect of Neurophysiological Facilitation Techniques in Intensive Care Patients
A study testing NPF Group in people with Intensive Care (ICU) Myopathy and Intensive Care Unit Acquired Weakness, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Intensive Care (ICU) Myopathy, Intensive Care Unit Acquired Weakness
- What is being tested?
- NPF Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2019to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- Having hemodynamic instability (intropin dose > 5 mcg/kg/min)
- Fever
- Malignity
- Shock
- Patients admitted to ICU after cardiac, trauma and surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- NPF Group, Control Group
- Keywords
- Intensive Care Unit, Critical Ill, Physiotherapy, Neurophysiologic Facilitation Techniques, Intensive Care Unit Acquired Weakness
- Medical subject headings
- Muscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPF GroupOther
Also called Neurophysiological facilitation techniques in addition to conventional physiotherapy.
Participants allocated to the experimental group completed until discharged, neurophysiological facilitation(NPF) techniques in addition to conventional physiotherapy.
Control GroupOther
Also called Conventional physiotherapy
Critical ill patients was applied their conventional physiotherapy which includes chest physiotherapy and mobilization until discharged
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Active comparator | We applied neurophysiological facilitation techniques in addition to conventional rehabilitation. Receives: Other: NPF Group |
| Control Group | Other | Critical ill patients was applied their conventional physiotherapy Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: through study completion, an average of 5 days
Secondary outcomes (9)
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
Measured: During ICU stay
Change in Blood Pressure
BP can be measured non-invasively using a sphygmomanometer (BP cuff).
Measured: During ICU stay
Change in Oxygen saturation
Pulse oximetry is the technique used to measure arterial oxygen saturation in the peripheral blood vessels
Measured: During ICU stay
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.
Measured: During ICU stay
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.
Measured: During ICU stay
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'.
Measured: During ICU stay
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).
Measured: through study completion, an average of 5 days
Change in Muscle Strength
Change in muscle strength was measured with a Digital Manual Muscle Tester.
Measured: through study completion, an average of 5 days
Change in Hand Grip Strength
Change in Hand Grip Strength was measured with a Hydraulic Hand Dynamometer.
Measured: through study completion, an average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start1 Oct 2019
- Primary completion1 Feb 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care (ICU) MyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Park Hospital Istanbul
- Responsible party
- Principal investigator, Mehmet Burak Uyaroğlu, Saglik Bilimleri Universitesi
- Investigators
- Mehmet Burak Uyaroğlu, PT,PhD, Study director, Saglik Bilimleri UniversitesiYasemin Çırak, Ass.Prof, Principal investigator, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282576
- Sponsor's protocol ID
- Saglik Bilimleri Uni
- Status last verified
- Mar 2022
- First submitted
- 26 Feb 2022
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neurophysiological Facilitation Techniques on Functional Levels and Respiratory in Intensive Care Patients
- ClinicalTrials.gov ID
- NCT05282576
- Acronym / sponsor ID
- Saglik Bilimleri Uni
- Keywords
- Intensive Care Unit, Critical Ill, Physiotherapy, Neurophysiologic Facilitation Techniques, Intensive Care Unit Acquired Weakness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Collaborators
- Medical Park Hospital Istanbul
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Active comparator | Other: NPF GroupWe applied neurophysiological facilitation techniques in addition to conventional rehabilitation. |
| Control Group | Other | Other: Control GroupCritical ill patients was applied their conventional physiotherapy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NPF GroupAlso: Neurophysiological facilitation techniques in addition to conventional physiotherapy.Participants allocated to the experimental group completed until discharged, neurophysiological facilitation(NPF) techniques in addition to conventional physiotherapy. | Other | Experimental Group |
| Control GroupAlso: Conventional physiotherapyCritical ill patients was applied their conventional physiotherapy which includes chest physiotherapy and mobilization until discharged | Other | Control Group |
Primary outcome
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.
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.
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
9 secondary outcomes
Change in Heart Rate
Time frame: During ICU stay
Change in Blood Pressure
Time frame: During ICU stay
Change in Oxygen saturation
Time frame: During ICU stay
Change in Respiratory Frequency
Time frame: During ICU stay
Change in Perception of Fatigue
Time frame: During ICU stay
Change in Perception of Dyspnea
Time frame: During ICU stay
The Functional Independence Measure
Time frame: through study completion, an average of 5 days
Change in Muscle Strength
Time frame: through study completion, an average of 5 days
Change in Hand Grip Strength
Time frame: through study completion, an average of 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet Burak Uyaroğlu, PT,PhD study director
Saglik Bilimleri Universitesi
Yasemin Çırak, Ass.Prof principal investigator
Istinye University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NPF Group in people with Intensive Care (ICU) Myopathy and Intensive Care Unit Acquired Weakness, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Chelsea Critical Care Physical Assessment Tool (time frame: through study completion, an average of 5 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.