COPD Exacerbation AcuteNCT06274957
The Effect of Airway and Chest Wall Oscillation on Respiratory Functions in COPD Patients in Acute Exacerbation
A study testing PEP DEVICE and HFCWO DEVICE in people with COPD Exacerbation Acute, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Chronic obstructive pulmonary disease (COPD); It is a common, treatable and preventable disease characterized by progressive and irreversible airflow limitation and has systemic effects with respiratory system involvement. Increased respiratory workload, decreased work . Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD Exacerbation Acute
- What is being tested?
- PEP DEVICE and HFCWO DEVICE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2024to 17 Jun 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being classified as GOLD stage 3 or 4 based on spirometric evaluation in the medical history.
- Having a hospital admission within the specified time frame, evaluated by a pulmonary specialist, and admitted to the pulmonary diseases service with a diagnosis of COPD exacerbation.
- Being 40 years of age or older.
- Voluntarily agreeing to participate in the study.
Who cannot join
- Having a hospital admission with a diagnosis of asthma attack in the last 5 years.
- Monitoring suspicious focal points for pneumonia on lung radiology.
- Hospitalization due to reasons other than exacerbation despite having a diagnosis of COPD.
- Presence of pulmonary fibrosis or suspicious findings of fibrosis on radiology.
- Systemic fungal infections.
- Having cognitive impairment affecting the decision to participate in the study, such as confusion, orientation disorder, or dementia.
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- Patients with lung cancer or metastasis in the lungs.
- Diagnosis of conditions provoking shortness of breath other than COPD exacerbation, such as pneumonia, pneumothorax, heart failure, and pulmonary embolism.
- Presence of a new-onset rhythm disorder or ischemic changes requiring intervention on the EKG, excluding sinus tachycardia and multifocal atrial tachycardia.
- Chronic kidney failure requiring hemodialysis.
- Patients with conditions causing weakness in the lower extremities, such as arthritis, neurological disease, deep vein thrombosis, peripheral artery disease, muscle weakness, fractures, osteoarthritis, etc.
- Having ankylosing spondylitis with a Cobb angle of 10 degrees or more in the radiographic evaluation of the vertebral column.
- Having undergone surgery on the upper extremities, lower extremities, neck, and back.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences
Istanbul, Turkey, 34353
About this study
Official title: The Effect of Airway Oscillation and Chest Wall Oscillation on Respiratory Functions and Sleep Quality in COPD Patients in Acute Exacerbation Period and Technical Inspection of Devices
Chronic obstructive pulmonary disease (COPD); It is a common, treatable and preventable disease characterized by progressive and irreversible airflow limitation and has systemic effects with respiratory system involvement. Increased respiratory workload, decreased work .
Read the detailed description
Chronic obstructive pulmonary disease (COPD); It is a common, treatable and preventable disease characterized by progressive and irreversible airflow limitation and has systemic effects with respiratory system involvement. Increased respiratory workload, decreased work of breathing in patients are important factors that cause respiratory and peripheral muscle strength and functional capacity exercise intolerance. It is defined as an exacerbation if there is an increase in shortness of breath, cough, sputum amount and purulence, which necessitates a change in treatment in the COPD patients. In the guides; Individualized exercise training for disease management is an essential component of these programs. In the literature; Although there are many studies showing the beneficial effects of traditional exercise training programs in patients with COPD, physiotherapy applications used in the exacerbation period are recommended, but there are not many studies examining the device technologies used in this area. In this period, devices that provide chest wall oscillation and airway oscillation can be preferred for the symptomatic treatment of increasing cough and sputum complaints. There is no study comparing these two methods that we know of. Our study will be carried out on 33 patients hospitalized in the Pulmonology Service of the Health Sciences University Gülhane Training and Research Hospital, followed up with the diagnosis of COPD exacerbation, who met the inclusion criteria and accepted to participate in the study on a voluntary basis. Patients will be randomized into 3 groups as 2 experiments and 1 control. Measurements of patients admitted to the ward will be made at the beginning and end of the study. Socio-demographic data of the patient, chest circumference measurement, COPD assessment test, mMRC dyspnea scale, BODE index, pulmonary function test, arterial blood gas, chest X-ray, 30-second sit and stand test, Richard-Campbell Sleep Scale, Clinical COPD Questionnaire, Charlson comorbidity index will be applied. Pursed-lip breathing, active breathing techniques cycle, bronchial hygiene techniques, mobilization, calisthenic exercises and patient education (teaching relaxation positions and energy conservation techniques) will be applied to the patients in the study and control groups during their hospitalization. Chest wall oscillation will be practiced together with chest physiotherapy in the 1st experimental group, and airway oscillation will be practiced in the 2nd experimental group with the same physiotherapy program. In the study, the clinical use and technical features of the devices will be examined.
- Conditions
- COPD Exacerbation Acute
- Being tested
- CONTROL, PEP DEVICE, HFCWO DEVICE
- Keywords
- copd, pep, hfcwo, airway clearance techniques
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONTROLOther
Pursed Lips breathing exercise, Active Respiratory Techniques Cycle, Postural Drainage, Mobilization, Calisthenic Exercises, and Patient Education. Relaxation positions and energy conservation techniques were taught in Patient Education
PEP DEVICEDevice
Pursed Lips breathing exercise, Active Respiratory Techniques Cycle, Postural Drainage, Mobilization, Calisthenic Exercises, and Patient Education. Relaxation positions and energy conservation techniques were taught in Patient Education
PEP training was applied using the Acapella device.
In addition, participants were subjected to two sessions of 10 minutes each with the Acapella device. In the study, the Acapella device, capable of sustaining expiratory flow of at least 15 L/min for 3 seconds, was activated by taking a deep breath, holding the breath for 2-3 seconds, and then exhaling into the device.
HFCWO DEVICEDevice
Patients were provided with conventional exercises including Pursed Lips breathing exercise, Active Respiratory Techniques Cycle, Postural Drainage, Mobilization, Calisthenic Exercises, and Patient Education. Relaxation positions and energy conservation techniques were taught in Patient Education
In addition, participants will receive High-Frequency Chest Wall Oscillation (HFCWO) therapy twice a day for 10 minutes each.
HFCWO training was applıed using the WEST device
| Study group | Role | What they receive |
|---|---|---|
| control | Experimental | Conventional training was applied to the patients Receives: Other: CONTROL |
| Positive Expiratory Pressure | Experimental | We applied PEP (positive expiratory pressure) therapy in adddition to the conventional exercises Receives: Device: PEP DEVICE |
| High Frequency Chest Wall Oscillation | Experimental | We applied HFCWO (High Frequency Chest Wall Oscillation) in addition to the conventional exercises Receives: Device: HFCWO DEVICE |
What is being measured
The primary outcome is the main question the study is designed to answer.
COPD assessment test
The COPD assessment test (CAT) includes eight items related to the severity of dyspnea, exercise capacity, cough, sputum, chest tightness, sleep quality, self-confidence, and energy levels. The CAT is a short and simple instrument to evaluate COPD patients, and its validated translations are present in a broad range of languages in the world. Additionally, the CAT is correlated with quality of life. According to the GOLD guidelines, patients with CAT score of ≥10 or mMRC score of ≥2 represents have more prominent symptoms. The cutoff points of more symptoms for CAT score ≥10 was validated in COPD. This threshold has been detected to have an important impact on the daily lives of patients with COPD.
Measured: The first and last day of the training will be measured an avarage 7 days
Clinical COPD Questionnaire
The Clinical COPD Questionnaire, developed by Thys Van der Molen, consisting of 10 items (4 items for symptoms, 4 items for functional status, and 2 items for mental status) assessing clinical control for the purpose of evaluating functional status, mental status, and symptoms, will be administered to all cases. In a study conducted by Reda and colleagues in 2010, it was demonstrated that the Clinical COPD Questionnaire is a valid, reliable, and sensitive tool for use in individuals at risk of COPD and in COPD patients
Measured: The first and last day of the training will be measured an avarage 7 days
mMRC dyspnea scale
The perception of dyspnea in patients will be assessed using the mMRC dyspnea scale. This scale, modified by ATS, evaluates dyspnea and limitations in daily life activities. Patients are asked to choose the most suitable expression from the five statements ranging from '0-4' (0: Only shortness of breath during heavy exercise; 4: Being housebound due to breathlessness, experiencing shortness of breath even during light activities such as dressing and undressing) to describe their own perception of dyspnea. The scale developed by Richards in 1987 consists of 6 items assessing the depth of nocturnal sleep, sleep onset latency, frequency of awakening, duration of wakefulness upon awakening, sleep quality, and ambient noise level. Each item is evaluated on a visual analog scale ranging from 0 to 100. Scores between "0-25" indicate very poor sleep, while scores between "76-100" indicate very good sleep. The scale's total score is assessed based on 5 items, excluding the 6th item evaluating
Measured: The first and last day of the training will be measured an avarage 7 days
Richard-Campbell Sleep Questionnaire
The scale developed by Richards in 1987 consists of 6 items assessing the depth of nocturnal sleep, sleep onset latency, frequency of awakening, duration of wakefulness upon awakening, sleep quality, and ambient noise level. Each item is evaluated on a visual analog scale ranging from 0 to 100. Scores between "0-25" indicate very poor sleep, while scores between "76-100" indicate very good sleep. The scale's total score is assessed based on 5 items, excluding the 6th item evaluating ambient noise level from the overall score. As the score on the scale increases, patients' sleep quality also improves. The Cronbach's alpha value for the scale, developed by Richards, was found to be 0.82. The Turkish validity and reliability of the scale were conducted by Özlü and Özer, revealing a Cronbach's alpha value of 0.91
Measured: The first and last day of the training will be measured an avarage 7 days
30 second sit and stand
test is primarily used for evaluating function and physical performance associated with mobility, and is suggested as an acceptable alternative method for assessing functional capacity in COPD. The patient, who has received medical treatment in an environment equipped with a chair with a seat height of approximately 44 cm and a backrest, preferably without armrests, a stopwatch, oxygen support if needed, a blood pressure monitor, and a defibrillator, and has not engaged in heavy activity in the last 2 hours, will be explained the test procedure in a comprehensible manner. Resting blood pressure, oxygen saturation, pulse, and modified Borg dyspnea score will be recorded. The patient will be instructed to cross their arms and touch both shoulders, then sit and stand up from the chair for 30 seconds in this position. At the end of the test, blood pressure, oxygen saturation, pulse, modified Borg dyspnea score, and the number of sit-to-stand repetitions within 30 seconds will be record
Measured: The first and last day of the training will be measured an avarage 7 days
BODE index
The BODE index has been developed to assess the mortality risk in patients with COPD. The BODE index comprises parameters such as BMI (Body Mass Index), the severity of airflow limitation, perceived degree of dyspnea, and exercise capacity. BMI will be calculated using the weight/height² formula, the severity of airflow limitation will be assessed by FEV1 % predicted, the perceived degree of dyspnea will be evaluated using the mMRC scale, and exercise capacity will be determined with the 6MWT (6-Minute Walk Test) in patients with COPD.
Measured: The first and last day of the training will be measured an avarage 7 days
chest circumference measurements
To assess chest mobility and respiratory type, chest circumference measurements will be taken using a tape measure at axillary (at the level of the 4th rib), epigastric (at the xiphoid process level), and subcostal (above the 11th and 12th ribs) regions. Measurements will be taken in an upright sitting position, during neutral, deep inspiration, and deep expiration. The difference between deep inspiration and deep expiration will be recorded in centimeters
Measured: The first and last day of the training will be measured an avarage 7 days
Modified Borg Scale
This scale was developed by Borg in 1970 for the purpose of measuring the perceived exertion during physical exercise. It is commonly used to assess the intensity of dyspnea during effort and at rest. Comprising ten grades that describe the severity of dyspnea, the Modified Borg Scale (MBS) makes it easier for patients by providing clear definitions for the intensity of dyspnea
Measured: The first and last day of the training will be measured an avarage 7 days
muscle strenght test
Muscle strength testing is used to determine the capability of the muscle or muscle group to produce force. It provides information that is useful in differential diagnosis, prognosis and management of neuromuscular and musculoskeletal disorders. its evaluating muscle strength is the Oxford Scale (AKA Medical Research Council Manual Muscle Testing scale). This method involves testing key muscles from the upper and lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale accordingly
Measured: The first and last day of the training will be measured an avarage 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start1 May 2024
- Primary completion10 Jun 2024
- Study completion17 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD Exacerbation AcuteStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Collaborators
- Gulhane Training and Research Hospital
- Responsible party
- Principal investigator, Gamze Altınkaynak, Saglik Bilimleri Universitesi
- Investigators
- ZUHAL KUNDURACILAR, PROF. DR., Study director, SAGLIK BILIMLERI UNIGAMZE KOYUTURK, PT, PHD (C), Principal investigator, SAGLIK BILIMLERI UNIAYSUNA DINCER, DOCTOR, Study chair, SAGLIK BILIMLERI UNIMEHMET YUKSEKKAYA, ASIST PROF, Study chair, ANKARA UNI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274957
- Sponsor's protocol ID
- SaglikBilimleriUN
- Status last verified
- Apr 2026
- First submitted
- 2 Feb 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Airway Oscillation and Chest Wall Oscillation on Respiratory Functions and Sleep Quality in COPD Patients in Acute Exacerbation Period and Technical Inspection of Devices
- ClinicalTrials.gov ID
- NCT06274957
- Acronym / sponsor ID
- SaglikBilimleriUN
- Conditions
- COPD Exacerbation Acute
- Keywords
- copd, pep, hfcwo, airway clearance techniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Collaborators
- Gulhane Training and Research Hospital
- Study start
- 1 May 2024 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 17 Jun 2024 (actual)
- First posted
- 23 Feb 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.
Chronic obstructive pulmonary disease (COPD); It is a common, treatable and preventable disease characterized by progressive and irreversible airflow limitation and has systemic effects with respiratory system involvement. Increased respiratory workload, decreased work .
Detailed description
Chronic obstructive pulmonary disease (COPD); It is a common, treatable and preventable disease characterized by progressive and irreversible airflow limitation and has systemic effects with respiratory system involvement. Increased respiratory workload, decreased work of breathing in patients are important factors that cause respiratory and peripheral muscle strength and functional capacity exercise intolerance. It is defined as an exacerbation if there is an increase in shortness of breath, cough, sputum amount and purulence, which necessitates a change in treatment in the COPD patients. In the guides; Individualized exercise training for disease management is an essential component of these programs. In the literature; Although there are many studies showing the beneficial effects of traditional exercise training programs in patients with COPD, physiotherapy applications used in the exacerbation period are recommended, but there are not many studies examining the device technologies used in this area. In this period, devices that provide chest wall oscillation and airway oscillation can be preferred for the symptomatic treatment of increasing cough and sputum complaints. There is no study comparing these two methods that we know of. Our study will be carried out on 33 patients hospitalized in the Pulmonology Service of the Health Sciences University Gülhane Training and Research Hospital, followed up with the diagnosis of COPD exacerbation, who met the inclusion criteria and accepted to participate in the study on a voluntary basis. Patients will be randomized into 3 groups as 2 experiments and 1 control. Measurements of patients admitted to the ward will be made at the beginning and end of the study. Socio-demographic data of the patient, chest circumference measurement, COPD assessment test, mMRC dyspnea scale, BODE index, pulmonary function test, arterial blood gas, chest X-ray, 30-second sit and stand test, Richard-Campbell Sleep Scale, Clinical COPD Questionnaire, Charlson comorbidity index will be applied. Pursed-lip breathing, active breathing techniques cycle, bronchial hygiene techniques, mobilization, calisthenic exercises and patient education (teaching relaxation positions and energy conservation techniques) will be applied to the patients in the study and control groups during their hospitalization. Chest wall oscillation will be practiced together with chest physiotherapy in the 1st experimental group, and airway oscillation will be practiced in the 2nd experimental group with the same physiotherapy program. In the study, the clinical use and technical features of the devices will be examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | Experimental | Other: CONTROLConventional training was applied to the patients |
| Positive Expiratory Pressure | Experimental | Device: PEP DEVICEWe applied PEP (positive expiratory pressure) therapy in adddition to the conventional exercises |
| High Frequency Chest Wall Oscillation | Experimental | Device: HFCWO DEVICEWe applied HFCWO (High Frequency Chest Wall Oscillation) in addition to the conventional exercises |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being classified as GOLD stage 3 or 4 based on spirometric evaluation in the medical history.
- Having a hospital admission within the specified time frame, evaluated by a pulmonary specialist, and admitted to the pulmonary diseases service with a diagnosis of COPD exacerbation.
- Being 40 years of age or older.
- Voluntarily agreeing to participate in the study.
Key exclusion criteria (13 listed)
- Having a hospital admission with a diagnosis of asthma attack in the last 5 years.
- Monitoring suspicious focal points for pneumonia on lung radiology.
- Hospitalization due to reasons other than exacerbation despite having a diagnosis of COPD.
- Presence of pulmonary fibrosis or suspicious findings of fibrosis on radiology.
- Systemic fungal infections.
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 |
|---|---|---|
| CONTROLPursed Lips breathing exercise, Active Respiratory Techniques Cycle, Postural Drainage, Mobilization, Calisthenic Exercises, and Patient Education. Relaxation positions and energy conservation techniques were taught in Patient Education | Other | control |
| PEP DEVICEPursed Lips breathing exercise, Active Respiratory Techniques Cycle, Postural Drainage, Mobilization, Calisthenic Exercises, and Patient Education. Relaxation positions and energy conservation techniques were taught in Patient Education PEP training was applied using the Acapella device. In addition, participants were subjected to two sessions of 10 minutes each with the Acapella device. In the study, the Acapella device, capable of sustaining expiratory flow of at least 15 L/min for 3 seconds, was activated by taking a deep breath, holding the breath for 2-3 seconds, and then exhaling into the device. | Device | Positive Expiratory Pressure |
| HFCWO DEVICEPatients were provided with conventional exercises including Pursed Lips breathing exercise, Active Respiratory Techniques Cycle, Postural Drainage, Mobilization, Calisthenic Exercises, and Patient Education. Relaxation positions and energy conservation techniques were taught in Patient Education In addition, participants will receive High-Frequency Chest Wall Oscillation (HFCWO) therapy twice a day for 10 minutes each. HFCWO training was applıed using the WEST device | Device | High Frequency Chest Wall Oscillation |
Primary outcome
COPD assessment test
Time frame: The first and last day of the training will be measured an avarage 7 days
The COPD assessment test (CAT) includes eight items related to the severity of dyspnea, exercise capacity, cough, sputum, chest tightness, sleep quality, self-confidence, and energy levels. The CAT is a short and simple instrument to evaluate COPD patients, and its validated translations are present in a broad range of languages in the world. Additionally, the CAT is correlated with quality of life. According to the GOLD guidelines, patients with CAT score of ≥10 or mMRC score of ≥2 represents have more prominent symptoms. The cutoff points of more symptoms for CAT score ≥10 was validated in COPD. This threshold has been detected to have an important impact on the daily lives of patients with COPD.
Clinical COPD Questionnaire
Time frame: The first and last day of the training will be measured an avarage 7 days
The Clinical COPD Questionnaire, developed by Thys Van der Molen, consisting of 10 items (4 items for symptoms, 4 items for functional status, and 2 items for mental status) assessing clinical control for the purpose of evaluating functional status, mental status, and symptoms, will be administered to all cases. In a study conducted by Reda and colleagues in 2010, it was demonstrated that the Clinical COPD Questionnaire is a valid, reliable, and sensitive tool for use in individuals at risk of COPD and in COPD patients
mMRC dyspnea scale
Time frame: The first and last day of the training will be measured an avarage 7 days
The perception of dyspnea in patients will be assessed using the mMRC dyspnea scale. This scale, modified by ATS, evaluates dyspnea and limitations in daily life activities. Patients are asked to choose the most suitable expression from the five statements ranging from '0-4' (0: Only shortness of breath during heavy exercise; 4: Being housebound due to breathlessness, experiencing shortness of breath even during light activities such as dressing and undressing) to describe their own perception of dyspnea. The scale developed by Richards in 1987 consists of 6 items assessing the depth of nocturnal sleep, sleep onset latency, frequency of awakening, duration of wakefulness upon awakening, sleep quality, and ambient noise level. Each item is evaluated on a visual analog scale ranging from 0 to 100. Scores between "0-25" indicate very poor sleep, while scores between "76-100" indicate very good sleep. The scale's total score is assessed based on 5 items, excluding the 6th item evaluating
Richard-Campbell Sleep Questionnaire
Time frame: The first and last day of the training will be measured an avarage 7 days
The scale developed by Richards in 1987 consists of 6 items assessing the depth of nocturnal sleep, sleep onset latency, frequency of awakening, duration of wakefulness upon awakening, sleep quality, and ambient noise level. Each item is evaluated on a visual analog scale ranging from 0 to 100. Scores between "0-25" indicate very poor sleep, while scores between "76-100" indicate very good sleep. The scale's total score is assessed based on 5 items, excluding the 6th item evaluating ambient noise level from the overall score. As the score on the scale increases, patients' sleep quality also improves. The Cronbach's alpha value for the scale, developed by Richards, was found to be 0.82. The Turkish validity and reliability of the scale were conducted by Özlü and Özer, revealing a Cronbach's alpha value of 0.91
30 second sit and stand
Time frame: The first and last day of the training will be measured an avarage 7 days
test is primarily used for evaluating function and physical performance associated with mobility, and is suggested as an acceptable alternative method for assessing functional capacity in COPD. The patient, who has received medical treatment in an environment equipped with a chair with a seat height of approximately 44 cm and a backrest, preferably without armrests, a stopwatch, oxygen support if needed, a blood pressure monitor, and a defibrillator, and has not engaged in heavy activity in the last 2 hours, will be explained the test procedure in a comprehensible manner. Resting blood pressure, oxygen saturation, pulse, and modified Borg dyspnea score will be recorded. The patient will be instructed to cross their arms and touch both shoulders, then sit and stand up from the chair for 30 seconds in this position. At the end of the test, blood pressure, oxygen saturation, pulse, modified Borg dyspnea score, and the number of sit-to-stand repetitions within 30 seconds will be record
BODE index
Time frame: The first and last day of the training will be measured an avarage 7 days
The BODE index has been developed to assess the mortality risk in patients with COPD. The BODE index comprises parameters such as BMI (Body Mass Index), the severity of airflow limitation, perceived degree of dyspnea, and exercise capacity. BMI will be calculated using the weight/height² formula, the severity of airflow limitation will be assessed by FEV1 % predicted, the perceived degree of dyspnea will be evaluated using the mMRC scale, and exercise capacity will be determined with the 6MWT (6-Minute Walk Test) in patients with COPD.
chest circumference measurements
Time frame: The first and last day of the training will be measured an avarage 7 days
To assess chest mobility and respiratory type, chest circumference measurements will be taken using a tape measure at axillary (at the level of the 4th rib), epigastric (at the xiphoid process level), and subcostal (above the 11th and 12th ribs) regions. Measurements will be taken in an upright sitting position, during neutral, deep inspiration, and deep expiration. The difference between deep inspiration and deep expiration will be recorded in centimeters
Modified Borg Scale
Time frame: The first and last day of the training will be measured an avarage 7 days
This scale was developed by Borg in 1970 for the purpose of measuring the perceived exertion during physical exercise. It is commonly used to assess the intensity of dyspnea during effort and at rest. Comprising ten grades that describe the severity of dyspnea, the Modified Borg Scale (MBS) makes it easier for patients by providing clear definitions for the intensity of dyspnea
muscle strenght test
Time frame: The first and last day of the training will be measured an avarage 7 days
Muscle strength testing is used to determine the capability of the muscle or muscle group to produce force. It provides information that is useful in differential diagnosis, prognosis and management of neuromuscular and musculoskeletal disorders. its evaluating muscle strength is the Oxford Scale (AKA Medical Research Council Manual Muscle Testing scale). This method involves testing key muscles from the upper and lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale accordingly
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 29 Apr 2026.
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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.
ZUHAL KUNDURACILAR, PROF. DR. study director
SAGLIK BILIMLERI UNI
GAMZE KOYUTURK, PT, PHD (C) principal investigator
SAGLIK BILIMLERI UNI
AYSUNA DINCER, DOCTOR study chair
SAGLIK BILIMLERI UNI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEP DEVICE and HFCWO DEVICE in people with COPD Exacerbation Acute, 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 13 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 29 Apr 2026. 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?
COPD assessment test (time frame: The first and last day of the training will be measured an avarage 7 days). The study lists 9 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 29 Apr 2026.