İntensive Care PatientsNCT06597136

The Effect of Kinesiology Tape Application on Functional Level and Respiratory Function in Intensive Care Unit Patients

A study testing Diaphragmatic kinesiology taping and Accessory respiratory muscle kinesiology taping in people with İntensive Care Patients, run by Istinye University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Investigation of the effects of respiratory muscles on the early functional system and respiratory function in the kinesiological period in intensive care patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: İntensive Care Patients
What is being tested?: Diaphragmatic kinesiology taping and Accessory respiratory muscle kinesiology taping
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 48 participants
Where: No sites listed yet
Study dates: 15 Sep 2024to 10 Nov 2024
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Individuals receiving inpatient treatment in intensive care who volunteer to participate in the research or who are allowed by their first-degree relatives if they are unconscious,
Being over 18 years of age
Being eligible to receive physiotherapy and rehabilitation from an intensive care physician
Are in clinically stable condition

Who cannot join

Patients with coagulation disorders (PT (Prothrombin Time); INR (International Normalized Ratio) value higher than 1.5 and platelet amount less than 50,000 m³)
Patients with signs of increased intracranial pressure
Skin wounds, ulcerations, allergic reactions
Patients in contact isolation due to infection
In shock
Having malignancy

Show all 9Show fewer

Having multiple organ failure
Having visual impairment
Patients who are unconscious

Trial locations and contacts

No sites are listed yet.

ELİF ÖRSELOĞLU, Msc contact

0905352211627

elif.orseloglu@istinye.edu.tr

About this study

Official title: Examination of the Effects of Kinesiology Tape Application for Respiratory Muscles on Early Functional Level and Respiratory Function in Intensive Care Unit Patients

Investigation of the effects of respiratory muscles on the early functional system and respiratory function in the kinesiological period in intensive care patients.

Read the detailed description

Weakness of respiratory muscles delays weaning from the ventilator, prolongs hospital stay and increases treatment costs. Conventional treatments for respiratory muscles reverse these negative effects. Kinesiology taping has effects that support the muscle to which it is applied, increase circulation and improve its function. Studies have shown positive effects of kinesiology taping applied to COPD patients, and in light of this, it has been predicted that its application to intensive care patients will be beneficial. The results of our study will shed light on the rehabilitation of patients in intensive care and contribute to the literature.

In this study, the investigators aimed to increase the activation of respiratory muscles by taking advantage of the benefits of kinesiology taping in addition to conventional treatment.

Our study, which included a total of 48 participants will consist of 4 groups. Only conventional treatment will be applied to the 1st group, diaphragmatic kinesiology taping will be applied to the 2nd group in addition to conventional treatment, kinesiological taping to the accessory respiratory muscles will be applied to the 3rd group and sham taping will be applied to the 4th group.

Conditions: İntensive Care Patients
Being tested: Diaphragmatic kinesiology taping, Accessory respiratory muscle kinesiology taping, Sham kinesiology taping
Keywords: intensive care, respiratory muscle strength, respiratory function, kinesiotape
Medical subject headings: Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Diaphragmatic kinesiology tapingOther
The taping on the diaphragm from the abdomen was performed when the participant was standing and breathed-out and the body was in extension. The base of the tape was about 1 inch below the xiphoid process area. Then the arms were lifted above the head and, with maximum deep inspiration and after maximum rib cage expansion, the tails were applied with 10% tension on the rib cage. Diaphragmatic kinesiology taping will be applied in addition to conventional treatment for 3 days.
Accessory respiratory muscle kinesiology tapingOther
Tapings of the accessory inspiratory muscles were applied in a sitting posture. Sternocleidomastoideus taping was applied when the neck of the participant was in lateral flexion to the opposite side to be taped and in rotation to the same side; and anterior and medius scalene tapings were applied when the neck of the participant was in the lateral flexion position to the opposite side to be taped. Tapings were repeated on the opposite side.Taping was applied to accessory expiratory muscles in the supine position. While the participant was supporting one leg in the hip and knee flexion position on the bed, the other leg was extended from the bed and the hip was kept in the extension position. The obliquus externus muscle was taped on the side with hip-knee flexion and the obliquus internus muscle was taped on the side with hip extension.In addition to conventional treatment, kinesiology taping will be applied to the accessory respiratory muscles for 3 days.
Sham kinesiology tapingOther
Sham kinesiology taping will be applied for 3 days. Sham KT was performed with the same taping material. A 2-blocked I strip was applied vertically to the sternum. The same procedures were followed.

Study groups in NCT06597136
Study group	Role	What they receive
Diaphragmatic kinesiology taping	Experimental	The taping on the diaphragm from the abdomen was performed when the participant was standing and breathed-out and the body was in extension. The base of the tape was about 1 inch below the xiphoid process area. Then the arms were lifted above the head and, with maximum deep inspiration and after maximum rib cage expansion, the tails were applied with 10% tension on the rib cage. Diaphragmatic kinesiology taping will be applied in addition to conventional treatment for 3 days. To evaluate the effectiveness of the application, vital signs, respiratory muscle strength, grip strength, blood gas analysis, dyspnea and fatigue will be evaluated. Additionally, Richmond Agitation Sedation Scale (RASS), Non-Verbal Pain Scale, Glaskow coma scale, Physical Function Test in Intensive Care (PFIT)- CPax (Chelsea Critical Care Physical Assessment Tool) scales will be used. Receives: Other: Diaphragmatic kinesiology taping
Accessory respiratory muscle kinesiology taping	Experimental	Tapings of the accessory inspiratory muscles were applied in a sitting posture. Sternocleidomastoideus taping was applied when the neck of the participant was in lateral flexion to the opposite side to be taped and in rotation to the same side; and anterior and medius scalene tapings were applied when the neck of the participant was in the lateral flexion position to the opposite side to be taped. Tapings were repeated on the opposite side.Taping was applied to accessory expiratory muscles in the supine position. While the participant was supporting one leg in the hip and knee flexion position on the bed, the other leg was extended from the bed and the hip was kept in the extension position. The obliquus externus muscle was taped on the side with hip-knee flexion and the obliquus internus muscle was taped on the side with hip extension.In addition to conventional treatment, kinesiology taping will be applied to the accessory respiratory muscles for 3 days. Receives: Other: Accessory respiratory muscle kinesiology taping
Sham kinesiology taping	Sham comparator	Sham kinesiology taping will be applied for 3 days. Sham KT was performed with the same taping material. A 2-blocked I strip was applied vertically to the sternum. The same procedures were followed. To evaluate the effectiveness of the application, vital signs, respiratory muscle strength, grip strength, blood gas analysis, dyspnea and fatigue will be evaluated. Additionally, Richmond Agitation Sedation Scale (RASS), Non-Verbal Pain Scale, Glaskow coma scale, Physical Function Test in Intensive Care (PFIT)- CPax (Chelsea Critical Care Physical Assessment Tool) scales will be used. Receives: Other: Sham kinesiology taping
Control Group	No intervention	Conventional treatment will be applied in the control group. Participants' vital signs, respiratory muscle strength, grip strength, blood gas analysis, dyspnea and fatigue will be evaluated. Additionally, Richmond Agitation Sedation Scale (RASS), Non-Verbal Pain Scale, Glaskow coma scale, Physical Function Test in Intensive Care (PFIT)- CPax (Chelsea Critical Care Physical Assessment Tool) scales will be used.

What is being measured

The primary outcome is the main question the study is designed to answer.

Respiratory Muscle Strength
Maximal inspiratory pressure (MIP) is a measure of the strength of inspiratory muscles, primarily the diaphragm, and allows for the assessment of ventilatory failure, restrictive lung disease and respiratory muscle strength. MIP is measured at residual volume of lung.
Measured: 3 days
Respiratory Muscle Strength
For respiratory muscle strength, maximal expiratory pressure (MEP) will evaluate using an electronic pressure transducer. MEP is measured from total lung capacity.particularly the diaphragm, while MEPs measure the strength of abdominal and intercostal muscles.
For respiratory muscle strength, maximal inspiratory pressure (MIP), and maximal expiratory pressure (MEP) were evaluated using an electronic pressure transducer. MIP was measured at residual volume, and MEP was measured from total lung capacity
Measured: 3 days
Richmond Agitation-Sedation Scale
Interrater reliability. In many intensive care units, the Richmond Agitation-Sedation Scale(RASS) is used to assess the level of sedation. This scale is designed with a three-step procedure that can help give a RASS score range of -5 to +4.The RASS score ranges from -5 (unarousable) to +4 (combative), with 0 meaning alert and calm.
Measured: 3 days
SOFA (Sequential Organ Failure Assessment)
It evaluates morbidity through six systems (liver, central nervous system, respiratory system, cardiovascular system,renal and coagulation). For each system, points between 1 and 4 are given and the total score is evaluated between 6 and 24. In this score, as the score increases for each system, organ failure is considered to occur.
Measured: 3 days
Visuel Anaolog Scale
A Visual Analogue Scale (VAS) is one of the pain rating scales used for the first time in 1921 by Hayes and Patterson[1]. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.For pain intensity according to VAS, "no pain" is usually rated as 0 points and "worst pain imaginable" as 10 points. Ranges for pain intensity; <3. mild pain, 3-6 moderate pain, >6 severe pain
Measured: 3 days
The Glasgow Coma Scale
It is a tool that healthcare providers use to measure decreases in consciousness. The scores from each section of the scale are useful for describing disruptions in nervous system function and also help providers track changes. It's the most widely used tool for measuring comas and decreases in consciousness.The components of the Glasgow Coma Scale include 4 different scores for the eye-opening response, 5 for the verbal response, and 6 for the motor response. The total score has values between 3 and 15. Three is the worst and 15 is the highest.
Measured: 3 days
APACHE II Score
It is a general measure of disease severity based on current physiologic measurements, age \& previous health conditions. The score can help in the assessment of patients to determine the level \& degree of diagnostic \& therapeutic intervention.APACHE II total score consists of three subheadings: acute physiology score, age and chronic health assessment; the highest value is 71. Mortality is 25% when the total score is 25, and increases to 80% when the total score is 35 and above.
Measured: 3 days
Chelsea Critical Care Physical Assessment Tool (CPAx)
İt is a test used on male and female patients in the intensive care unit (ICU) to assess physical and respiratory function impairments and morbidity.
Measured: 3 days
Body temperature
The average normal body temperature is generally accepted as 37°C. Some studies have shown that the "normal" body temperature can have a wide range, from 36.1°C to 37.2°C
Measured: 3 days
Blood pressure
Normal blood pressure for most adults is defined as a systolic pressure of less than 120 and a diastolic pressure of less than 80. Elevated blood pressure is defined as a systolic pressure between 120 and 129 with a diastolic pressure of less than 80.
Measured: 3 days
Respiratory rate
The normal range of breathing rate per minute in an average adult, for a person at rest, is 12 - 20 breaths per minute. Any person having a breathing rate under 12 or over 25 is considered to be breathing abnormally.
Measured: 3 days
Pulse rate
The normal pulse for healthy adults ranges from 60 to 100 beats per minute. The pulse rate may fluctuate and increase with exercise, illness, injury, and emotions.
Measured: 3 days
The Physical Function in ICU Test
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.
Measured: 3 days
Hand Strength
Hand muscle strength will be measured with a jamar device
Measured: 3 days
Modified Borg Dyspnea Scale
It is a categorical scale with a score from 0 to 10, where 0 represents normal breathing and 10 represents maximum dyspnea.
Measured: 3 days
Pa02
It is the partial pressure of oxygen in arterial blood. It is used to evaluate oxygenation.Normal values are 80-100 mmHg.
Measured: 3 days
PaC02
It is the partial pressure of carbon dioxide in arterial blood. It is an indicator of alveolar ventilation. Normal values are 35-45 mmHg.
Measured: 3 days
HCO3
It is the serum concentration of bicarbonate ion. It is an important buffer in the blood and is used to evaluate the metabolic component of acid-base balance. Standard bicarbonate: It is the bicarbonate value that should be present in the blood under standard conditions (37°C temperature and 40 mmHg PCO2). Normally it is 22-26 mEq/L.
Measured: 3 days
Ph
It is used to determine the H+ status of the blood. It shows that the patient is in acidosis or alkalosis, but it is not possible to understand the type by pH. Normal values are 7.35-7.45.
Measured: 3 days
Confusion Assessment Method for the ICU
The Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) is a tool used to assess delirium among patients in the intensive care unit. The CAM-ICU assesses for the four features of delirium:Feature 1 is an acute change in mental status or a fluctuating mental status, Feature 2, is inattention, Feature 3,is altered level of consciousness and Feature 4, is disorganized thinking.
patients in the intensive care unit
Measured: 3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Sep 202410 Nov 2024

First posted19 Sep 2024
Study start15 Sep 2024 (estimated)
Primary completionOct 2024 (estimated)
Study completion10 Nov 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for İntensive Care PatientsStudies of the same condition, open and under way.
More trials run by Istinye UniversityThe sponsor's other registered studies.
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: Supportive care
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 48 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06597136
Sponsor's protocol ID: IstinyeU-ORSELOGLU-001
Status last verified: Sep 2024
First submitted: 1 May 2024
Last updated: 19 Sep 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR) might be considered to be shared with clinicians studying in the same field one year after the publication of the study

Publications

Berger D, Bloechlinger S, von Haehling S, Doehner W, Takala J, Z'Graggen WJ, Schefold JC. Dysfunction of respiratory muscles in critically ill patients on the intensive care unit. J Cachexia Sarcopenia Muscle. 2016 Sep;7(4):403-12. doi: 10.1002/jcsm.12108. Epub 2016 Mar 9.
PubMed 27030815
Makhabah DN, Martino F, Ambrosino N. Peri-operative physiotherapy. Multidiscip Respir Med. 2013 Jan 23;8(1):4. doi: 10.1186/2049-6958-8-4.
PubMed 23343253
Yousefnia-Darzi F, Hasavari F, Khaleghdoost T, Kazemnezhad-Leyli E, Khalili M. Effects of thoracic squeezing on airway secretion removal in mechanically ventilated patients. Iran J Nurs Midwifery Res. 2016 May-Jun;21(3):337-42. doi: 10.4103/1735-9066.180374.
PubMed 27186214
Kalanuria AA, Ziai W, Mirski M. Ventilator-associated pneumonia in the ICU. Crit Care. 2014 Mar 18;18(2):208. doi: 10.1186/cc13775. No abstract available.
PubMed 25029020
Ratnovsky A, Elad D, Halpern P. Mechanics of respiratory muscles. Respir Physiol Neurobiol. 2008 Nov 30;163(1-3):82-9. doi: 10.1016/j.resp.2008.04.019. Epub 2008 May 15.
PubMed 18583200
Castro-Avila AC, Seron P, Fan E, Gaete M, Mickan S. Effect of Early Rehabilitation during Intensive Care Unit Stay on Functional Status: Systematic Review and Meta-Analysis. PLoS One. 2015 Jul 1;10(7):e0130722. doi: 10.1371/journal.pone.0130722. eCollection 2015.
PubMed 26132803
Parker A, Sricharoenchai T, Needham DM. Early Rehabilitation in the Intensive Care Unit: Preventing Physical and Mental Health Impairments. Curr Phys Med Rehabil Rep. 2013 Dec;1(4):307-314. doi: 10.1007/s40141-013-0027-9.
PubMed 24436844
Morris D, Jones D, Ryan H, Ryan CG. The clinical effects of Kinesio(R) Tex taping: A systematic review. Physiother Theory Pract. 2013 May;29(4):259-70. doi: 10.3109/09593985.2012.731675. Epub 2012 Oct 22.
PubMed 23088702
Jang MH, Shin MJ, Shin YB. Pulmonary and Physical Rehabilitation in Critically Ill Patients. Acute Crit Care. 2019 Feb;34(1):1-13. doi: 10.4266/acc.2019.00444. Epub 2019 Feb 28.
PubMed 31723900
Zeng R, Tian K, Xiao Z. Effectiveness of thoracic kinesio taping on respiratory function and muscle strength in patients with chronic obstructive pulmonary disease: A protocol of randomized, double-blind placebo-controlled trial. Medicine (Baltimore). 2021 Apr 9;100(14):e25269. doi: 10.1097/MD.0000000000025269.
PubMed 33832089
Denehy L, de Morton NA, Skinner EH, Edbrooke L, Haines K, Warrillow S, Berney S. A physical function test for use in the intensive care unit: validity, responsiveness, and predictive utility of the physical function ICU test (scored). Phys Ther. 2013 Dec;93(12):1636-45. doi: 10.2522/ptj.20120310. Epub 2013 Jul 25.
PubMed 23886842
Corner EJ, Wood H, Englebretsen C, Thomas A, Grant RL, Nikoletou D, Soni N. The Chelsea critical care physical assessment tool (CPAx): validation of an innovative new tool to measure physical morbidity in the general adult critical care population; an observational proof-of-concept pilot study. Physiotherapy. 2013 Mar;99(1):33-41. doi: 10.1016/j.physio.2012.01.003. Epub 2012 Mar 30.
PubMed 23219649

Want to know more?

ELİF ÖRSELOĞLU, Msc

0905352211627

elif.orseloglu@istinye.edu.tr

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All İntensive Care Patients trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Examination of the Effects of Kinesiology Tape Application for Respiratory Muscles on Early Functional Level and Respiratory Function in Intensive Care Unit Patients
ClinicalTrials.gov ID: NCT06597136
Acronym / sponsor ID: IstinyeU-ORSELOGLU-001
Conditions: İntensive Care Patients
Keywords: intensive care, respiratory muscle strength, respiratory function, kinesiotape
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 48 participants (estimated)
Lead sponsor: Istinye UniversityUniversity, hospital or other
Study start: 15 Sep 2024 (estimated)
Primary completion: Oct 2024 (estimated)
Study completion: 10 Nov 2024 (estimated)
First posted: 19 Sep 2024 (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.

Investigation of the effects of respiratory muscles on the early functional system and respiratory function in the kinesiological period in intensive care patients.

Detailed description

In this study, the investigators aimed to increase the activation of respiratory muscles by taking advantage of the benefits of kinesiology taping in addition to conventional treatment.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Diaphragmatic kinesiology taping	Experimental	Other: Diaphragmatic kinesiology tapingThe taping on the diaphragm from the abdomen was performed when the participant was standing and breathed-out and the body was in extension. The base of the tape was about 1 inch below the xiphoid process area. Then the arms were lifted above the head and, with maximum deep inspiration and after maximum rib cage expansion, the tails were applied with 10% tension on the rib cage. Diaphragmatic kinesiology taping will be applied in addition to conventional treatment for 3 days. To evaluate the effectiveness of the application, vital signs, respiratory muscle strength, grip strength, blood gas analysis, dyspnea and fatigue will be evaluated. Additionally, Richmond Agitation Sedation Scale (RASS), Non-Verbal Pain Scale, Glaskow coma scale, Physical Function Test in Intensive Care (PFIT)- CPax (Chelsea Critical Care Physical Assessment Tool) scales will be used.
Accessory respiratory muscle kinesiology taping	Experimental	Other: Accessory respiratory muscle kinesiology tapingTapings of the accessory inspiratory muscles were applied in a sitting posture. Sternocleidomastoideus taping was applied when the neck of the participant was in lateral flexion to the opposite side to be taped and in rotation to the same side; and anterior and medius scalene tapings were applied when the neck of the participant was in the lateral flexion position to the opposite side to be taped. Tapings were repeated on the opposite side.Taping was applied to accessory expiratory muscles in the supine position. While the participant was supporting one leg in the hip and knee flexion position on the bed, the other leg was extended from the bed and the hip was kept in the extension position. The obliquus externus muscle was taped on the side with hip-knee flexion and the obliquus internus muscle was taped on the side with hip extension.In addition to conventional treatment, kinesiology taping will be applied to the accessory respiratory muscles for 3 days.
Sham kinesiology taping	Sham comparator	Other: Sham kinesiology tapingSham kinesiology taping will be applied for 3 days. Sham KT was performed with the same taping material. A 2-blocked I strip was applied vertically to the sternum. The same procedures were followed. To evaluate the effectiveness of the application, vital signs, respiratory muscle strength, grip strength, blood gas analysis, dyspnea and fatigue will be evaluated. Additionally, Richmond Agitation Sedation Scale (RASS), Non-Verbal Pain Scale, Glaskow coma scale, Physical Function Test in Intensive Care (PFIT)- CPax (Chelsea Critical Care Physical Assessment Tool) scales will be used.
Control Group	No intervention	–Conventional treatment will be applied in the control group. Participants' vital signs, respiratory muscle strength, grip strength, blood gas analysis, dyspnea and fatigue will be evaluated. Additionally, Richmond Agitation Sedation Scale (RASS), Non-Verbal Pain Scale, Glaskow coma scale, Physical Function Test in Intensive Care (PFIT)- CPax (Chelsea Critical Care Physical Assessment Tool) scales will be used.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Individuals receiving inpatient treatment in intensive care who volunteer to participate in the research or who are allowed by their first-degree relatives if they are unconscious,
Being over 18 years of age
Being eligible to receive physiotherapy and rehabilitation from an intensive care physician
Are in clinically stable condition

Key exclusion criteria (9 listed)

Patients with coagulation disorders (PT (Prothrombin Time); INR (International Normalized Ratio) value higher than 1.5 and platelet amount less than 50,000 m³)
Patients with signs of increased intracranial pressure
Skin wounds, ulcerations, allergic reactions
Patients in contact isolation due to infection
In shock

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
Diaphragmatic kinesiology tapingThe taping on the diaphragm from the abdomen was performed when the participant was standing and breathed-out and the body was in extension. The base of the tape was about 1 inch below the xiphoid process area. Then the arms were lifted above the head and, with maximum deep inspiration and after maximum rib cage expansion, the tails were applied with 10% tension on the rib cage. Diaphragmatic kinesiology taping will be applied in addition to conventional treatment for 3 days.	Other	Diaphragmatic kinesiology taping
Accessory respiratory muscle kinesiology tapingTapings of the accessory inspiratory muscles were applied in a sitting posture. Sternocleidomastoideus taping was applied when the neck of the participant was in lateral flexion to the opposite side to be taped and in rotation to the same side; and anterior and medius scalene tapings were applied when the neck of the participant was in the lateral flexion position to the opposite side to be taped. Tapings were repeated on the opposite side.Taping was applied to accessory expiratory muscles in the supine position. While the participant was supporting one leg in the hip and knee flexion position on the bed, the other leg was extended from the bed and the hip was kept in the extension position. The obliquus externus muscle was taped on the side with hip-knee flexion and the obliquus internus muscle was taped on the side with hip extension.In addition to conventional treatment, kinesiology taping will be applied to the accessory respiratory muscles for 3 days.	Other	Accessory respiratory muscle kinesiology taping
Sham kinesiology tapingSham kinesiology taping will be applied for 3 days. Sham KT was performed with the same taping material. A 2-blocked I strip was applied vertically to the sternum. The same procedures were followed.	Other	Sham kinesiology taping

Primary outcome

Respiratory Muscle Strength
Time frame: 3 days
Maximal inspiratory pressure (MIP) is a measure of the strength of inspiratory muscles, primarily the diaphragm, and allows for the assessment of ventilatory failure, restrictive lung disease and respiratory muscle strength. MIP is measured at residual volume of lung.
Respiratory Muscle Strength
Time frame: 3 days
For respiratory muscle strength, maximal expiratory pressure (MEP) will evaluate using an electronic pressure transducer. MEP is measured from total lung capacity.particularly the diaphragm, while MEPs measure the strength of abdominal and intercostal muscles. For respiratory muscle strength, maximal inspiratory pressure (MIP), and maximal expiratory pressure (MEP) were evaluated using an electronic pressure transducer. MIP was measured at residual volume, and MEP was measured from total lung capacity
Richmond Agitation-Sedation Scale
Time frame: 3 days
Interrater reliability. In many intensive care units, the Richmond Agitation-Sedation Scale(RASS) is used to assess the level of sedation. This scale is designed with a three-step procedure that can help give a RASS score range of -5 to +4.The RASS score ranges from -5 (unarousable) to +4 (combative), with 0 meaning alert and calm.
SOFA (Sequential Organ Failure Assessment)
Time frame: 3 days
It evaluates morbidity through six systems (liver, central nervous system, respiratory system, cardiovascular system,renal and coagulation). For each system, points between 1 and 4 are given and the total score is evaluated between 6 and 24. In this score, as the score increases for each system, organ failure is considered to occur.
Visuel Anaolog Scale
Time frame: 3 days
A Visual Analogue Scale (VAS) is one of the pain rating scales used for the first time in 1921 by Hayes and Patterson[1]. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.For pain intensity according to VAS, "no pain" is usually rated as 0 points and "worst pain imaginable" as 10 points. Ranges for pain intensity; <3. mild pain, 3-6 moderate pain, >6 severe pain
The Glasgow Coma Scale
Time frame: 3 days
It is a tool that healthcare providers use to measure decreases in consciousness. The scores from each section of the scale are useful for describing disruptions in nervous system function and also help providers track changes. It's the most widely used tool for measuring comas and decreases in consciousness.The components of the Glasgow Coma Scale include 4 different scores for the eye-opening response, 5 for the verbal response, and 6 for the motor response. The total score has values between 3 and 15. Three is the worst and 15 is the highest.
APACHE II Score
Time frame: 3 days
It is a general measure of disease severity based on current physiologic measurements, age \& previous health conditions. The score can help in the assessment of patients to determine the level \& degree of diagnostic \& therapeutic intervention.APACHE II total score consists of three subheadings: acute physiology score, age and chronic health assessment; the highest value is 71. Mortality is 25% when the total score is 25, and increases to 80% when the total score is 35 and above.
Chelsea Critical Care Physical Assessment Tool (CPAx)
Time frame: 3 days
İt is a test used on male and female patients in the intensive care unit (ICU) to assess physical and respiratory function impairments and morbidity.
Body temperature
Time frame: 3 days
The average normal body temperature is generally accepted as 37°C. Some studies have shown that the "normal" body temperature can have a wide range, from 36.1°C to 37.2°C
Blood pressure
Time frame: 3 days
Normal blood pressure for most adults is defined as a systolic pressure of less than 120 and a diastolic pressure of less than 80. Elevated blood pressure is defined as a systolic pressure between 120 and 129 with a diastolic pressure of less than 80.
Respiratory rate
Time frame: 3 days
The normal range of breathing rate per minute in an average adult, for a person at rest, is 12 - 20 breaths per minute. Any person having a breathing rate under 12 or over 25 is considered to be breathing abnormally.
Pulse rate
Time frame: 3 days
The normal pulse for healthy adults ranges from 60 to 100 beats per minute. The pulse rate may fluctuate and increase with exercise, illness, injury, and emotions.
The Physical Function in ICU Test
Time frame: 3 days
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.
Hand Strength
Time frame: 3 days
Hand muscle strength will be measured with a jamar device
Modified Borg Dyspnea Scale
Time frame: 3 days
It is a categorical scale with a score from 0 to 10, where 0 represents normal breathing and 10 represents maximum dyspnea.
Pa02
Time frame: 3 days
It is the partial pressure of oxygen in arterial blood. It is used to evaluate oxygenation.Normal values are 80-100 mmHg.
PaC02
Time frame: 3 days
It is the partial pressure of carbon dioxide in arterial blood. It is an indicator of alveolar ventilation. Normal values are 35-45 mmHg.
HCO3
Time frame: 3 days
It is the serum concentration of bicarbonate ion. It is an important buffer in the blood and is used to evaluate the metabolic component of acid-base balance. Standard bicarbonate: It is the bicarbonate value that should be present in the blood under standard conditions (37°C temperature and 40 mmHg PCO2). Normally it is 22-26 mEq/L.
Ph
Time frame: 3 days
It is used to determine the H+ status of the blood. It shows that the patient is in acidosis or alkalosis, but it is not possible to understand the type by pH. Normal values are 7.35-7.45.
Confusion Assessment Method for the ICU
Time frame: 3 days
The Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) is a tool used to assess delirium among patients in the intensive care unit. The CAM-ICU assesses for the four features of delirium:Feature 1 is an acute change in mental status or a fluctuating mental status, Feature 2, is inattention, Feature 3,is altered level of consciousness and Feature 4, is disorganized thinking. patients in the intensive care unit

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Background: PubMed 27030815Berger D, Bloechlinger S, von Haehling S, Doehner W, Takala J, Z'Graggen WJ, Schefold JC. Dysfunction of respiratory muscles in critically ill patients on the intensive care unit. J Cachexia Sarcopenia Muscle. 2016 Sep;7(4):403-12. doi: 10.1002/jcsm.12108. Epub 2016 Mar 9.
Background: PubMed 23343253Makhabah DN, Martino F, Ambrosino N. Peri-operative physiotherapy. Multidiscip Respir Med. 2013 Jan 23;8(1):4. doi: 10.1186/2049-6958-8-4.
Background: PubMed 27186214Yousefnia-Darzi F, Hasavari F, Khaleghdoost T, Kazemnezhad-Leyli E, Khalili M. Effects of thoracic squeezing on airway secretion removal in mechanically ventilated patients. Iran J Nurs Midwifery Res. 2016 May-Jun;21(3):337-42. doi: 10.4103/1735-9066.180374.
Background: PubMed 25029020Kalanuria AA, Ziai W, Mirski M. Ventilator-associated pneumonia in the ICU. Crit Care. 2014 Mar 18;18(2):208. doi: 10.1186/cc13775. No abstract available.
Background: PubMed 18583200Ratnovsky A, Elad D, Halpern P. Mechanics of respiratory muscles. Respir Physiol Neurobiol. 2008 Nov 30;163(1-3):82-9. doi: 10.1016/j.resp.2008.04.019. Epub 2008 May 15.
Background: PubMed 26132803Castro-Avila AC, Seron P, Fan E, Gaete M, Mickan S. Effect of Early Rehabilitation during Intensive Care Unit Stay on Functional Status: Systematic Review and Meta-Analysis. PLoS One. 2015 Jul 1;10(7):e0130722. doi: 10.1371/journal.pone.0130722. eCollection 2015.
Background: PubMed 24436844Parker A, Sricharoenchai T, Needham DM. Early Rehabilitation in the Intensive Care Unit: Preventing Physical and Mental Health Impairments. Curr Phys Med Rehabil Rep. 2013 Dec;1(4):307-314. doi: 10.1007/s40141-013-0027-9.
Background: PubMed 23088702Morris D, Jones D, Ryan H, Ryan CG. The clinical effects of Kinesio(R) Tex taping: A systematic review. Physiother Theory Pract. 2013 May;29(4):259-70. doi: 10.3109/09593985.2012.731675. Epub 2012 Oct 22.
Background: PubMed 31723900Jang MH, Shin MJ, Shin YB. Pulmonary and Physical Rehabilitation in Critically Ill Patients. Acute Crit Care. 2019 Feb;34(1):1-13. doi: 10.4266/acc.2019.00444. Epub 2019 Feb 28.
Background: PubMed 33832089Zeng R, Tian K, Xiao Z. Effectiveness of thoracic kinesio taping on respiratory function and muscle strength in patients with chronic obstructive pulmonary disease: A protocol of randomized, double-blind placebo-controlled trial. Medicine (Baltimore). 2021 Apr 9;100(14):e25269. doi: 10.1097/MD.0000000000025269.
Background: PubMed 23886842Denehy L, de Morton NA, Skinner EH, Edbrooke L, Haines K, Warrillow S, Berney S. A physical function test for use in the intensive care unit: validity, responsiveness, and predictive utility of the physical function ICU test (scored). Phys Ther. 2013 Dec;93(12):1636-45. doi: 10.2522/ptj.20120310. Epub 2013 Jul 25.
Background: PubMed 23219649Corner EJ, Wood H, Englebretsen C, Thomas A, Grant RL, Nikoletou D, Soni N. The Chelsea critical care physical assessment tool (CPAx): validation of an innovative new tool to measure physical morbidity in the general adult critical care population; an observational proof-of-concept pilot study. Physiotherapy. 2013 Mar;99(1):33-41. doi: 10.1016/j.physio.2012.01.003. Epub 2012 Mar 30.
Individual participant dataSharing planned: No. Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR) might be considered to be shared with clinicians studying in the same field one year after the publication of the study

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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.

ELİF ÖRSELOĞLU, Msc contact

0905352211627

elif.orseloglu@istinye.edu.tr

Yasemin Çırak, Prof Dr. study director

İstinye University

Questions about this trial

What is this clinical trial studying?

A study testing Diaphragmatic kinesiology taping and Accessory respiratory muscle kinesiology taping in people with İntensive Care Patients, run by Istinye University.

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 9 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact ELİF ÖRSELOĞLU, Msc (0905352211627, elif.orseloglu@istinye.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Respiratory Muscle Strength (time frame: 3 days). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06597136, which also lists 12 linked publications.

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 19 Sep 2024; AzTrials last refreshed its copy on 6 Nov 2026.