Chronic Obstructive Pulmonary DiseaseNCT04995510
Respiratory Muscle Function, Diaphragm Thickness and Health Related Physical Fitness Parameters in Individuals
An observational study of Chronic Obstructive Pulmonary Disease, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
In the literature, studies evaluating respiratory muscle function, diaphragm thickness and health-related physical fitness parameters together are insufficient in individuals with chronic obstructive pulmonary disease. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Observational
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Jul 2021to 18 Dec 2021
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic Obstructive Pulmonary Disease (COPD) is a common, preventable, and treatable disease characterized by persistent airflow limitation, usually progressive, associated with an increased chronic inflammatory response of the airways and lung to noxious gases and particles. In addition, healthy individuals in a similar age range without a diagnosed disease and symptoms will be included in the study.
Who may be able to join
- Individuals diagnosed with chronic obstructive pulmonary disease
- Be between the ages of 40-65
- No medication changes due to acute exacerbation for at least three weeks
- Be stable
- Volunteering to participate in research
- To cooperate
- Patients with written consent form
- Healthy individuals in a similar age range without a diagnosed disease and symptoms will be included
Who cannot join
- Those with a history of chronic obstructive pulmonary disease exacerbations
- Individuals with orthopedic disease
- Individuals with neurological disease
- Individuals with other co-existing lung and systemic diseases other than chronic obstructive pulmonary disease
- Those who have had major surgery in the past few months
- Individuals with a history of recurrent significant clinical infections
Show all 11Show fewer
- Have cognitive problems
- Having had unstable angina,
- Previous Myocardial Infarction
- Individuals with severe congestive heart failure refractory to medical therapy, individuals with uncontrolled hypertension
- Individuals with cancer
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bolu Abant İzzet Baysal University Department of Physiotherapy and Rehabilitation
Bolu, 14000
Eylem TÜTÜN YÜMİN, Assoc. Prof., +90 505 676 31 91, eylemtutun78@hotmail.com
Ceyhun TOPCUOĞLU, Res. Assist., +90 535 653 51 37, ceyhuntopcuoglu1@gmail.com
About this study
Official title: Examination of Respiratory Muscle Function, Diaphragm Thickness and Health Related Physical Fitness Parameters in Chronic Obstructive Pulmonary Disease Individuals
In the literature, studies evaluating respiratory muscle function, diaphragm thickness and health-related physical fitness parameters together are insufficient in individuals with chronic obstructive pulmonary disease. In the thesis study, it is thought that the respiratory muscle function, diaphragm thickness, health-related physical fitness parameters, physical activity and lung functions of individuals with chronic obstructive pulmonary disease can be evaluated together to contribute to the literature. The aim of this study is to evaluate diaphragm thickness, respiratory muscle strength, endurance, body composition, aerobic exercise capacity, upper and lower extremity muscle strength and endurance, grip strength, flexibility in individuals with chronic obstructive pulmonary disease and compare them with the healthy group.
Read the detailed description
Breathing is the exchange of oxygen and carbon dioxide gases with inspiration (breathing in) and expiration (breathing) in order to maintain the optimum oxygen level in arterial blood. Respiration takes place through respiratory muscles. While inspiration takes place through the diaphragm and accessory respiratory muscles; Expiration takes place passively. Respiratory muscle function is determined by evaluating respiratory muscle strength and respiratory muscle endurance together. respiratory muscle dysfunction; It is a decrease in respiratory muscle strength, endurance, or both, caused by factors such as elongated diaphragm fibers, increased respiratory workload, changes in muscle mass and abdominal weight. Today, respiratory muscle strength are widely used in the evaluation of respiratory muscle function. However, evaluation of respiratory muscle endurance is more effective than respiratory muscle strength in the evaluation of submaximal respiratory muscle contraction, which is valid for daily activities, and in the clinical, functional and prognostic evaluation of respiratory muscles. In chronic obstructive pulmonary disease, respiratory muscle function is associated with pulmonary functions, symptoms, comorbidities, health status, airway obstruction, lung volumes, and physiological disorders. Respiratory muscle dysfunction in chronic obstructive pulmonary disease increases with disease progression. Dysfunction in the diaphragm, which is the most important respiratory muscle, can be evaluated with respiratory muscle strength and endurance, as well as diaphragm thickness. Diaphragm thickness provides information about disease progression in individuals with chronic obstructive pulmonary disease. It is known that diaphragm thickness is associated with respiratory muscle strength and respiratory function parameters in individuals with chronic obstructive pulmonary disease.
The World Health Organization defines health as "a state of complete physical, social and mental well-being and not merely the absence of disease or infirmity". One of the important factors for maintaining health is physical fitness. physical fitness; It is the ability to perform occupational, recreational and daily activities correctly and successfully without fatigue. Physical fitness is also known as the ability to do daily tasks vigorously and carefully, without excessive fatigue, and to allocate sufficient energy for leisure and unexpected emergencies. Physical fitness is divided into two as health-related physical fitness and sports-related physical fitness. While health-related physical fitness parameters are body composition, cardiorespiratory fitness, muscular strength and endurance, flexibility; Sport-related physical fitness parameters are balance, coordination, reaction time, agility, speed and power. Decreased physical fitness in individuals with chronic obstructive pulmonary disease is associated with respiratory problems (such as airway obstruction). It is known that physical fitness is related to the ability to perform physical activity. Low physical fitness occurs in most individuals with chronic obstructive pulmonary disease due to decreased physical activity. There is an important relationship between physical fitness and lung functions.
In the literature, studies evaluating respiratory muscle function, diaphragm thickness and health-related physical fitness parameters together are insufficient in individuals with chronic obstructive pulmonary disease. In the thesis study, which is planned to be done, it is thought that the respiratory muscle function, diaphragm thickness, health-related physical fitness parameters, physical activity and lung functions of individuals with chronic obstructive pulmonary disease can be evaluated together to contribute to the literature.
The aim of this study is to evaluate diaphragm thickness, respiratory muscle strength, endurance, body composition, aerobic exercise capacity, upper and lower extremity muscle strength and endurance, grip strength, flexibility in individuals with chronic obstructive pulmonary disease and compare them with the healthy group.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Observational
- Keywords
- Chronic Obstructive Pulmonary Disease, diaphragm thickness, respiratory muscle function, body composition, physical fitness
- 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.
ObservationalOther
To evaluate your chronic obstructive pulmonary disease with Chronic Obstructive Pulmonary Disease assessment test, respiratory muscle strength with intraoral pressure measurement device, respiratory muscle endurance with increasing threshold load respiratory muscle endurance test, diaphragm thickness with ultrasound device, cardiorespiratory fitness with 6 Minute Walk Test, flexibility trunk lateral flexion test , back scratch test and sit and lie down test, muscle strength and endurance will be evaluated with push-up test, sit-up test, sit and stand test and hand grip strength, body composition will be evaluated by bioelectrical impedance analysis, physical activity will be questioned with the International Physical Activity Assessment Questionnaire, shortness of breath with the Mmrc Dyspnea Scale, and perception of fatigue and shortness of breath with the Modified Borg Scale.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Obstructive Pulmonary Disease Group | Individuals diagnosed with chronic obstructive pulmonary disease by ''Bolu Abant Izzet Baysal University'' Faculty of Medicine, Department of Chest Diseases and referred to the Physiotherapy and Rehabilitation Department of Bolu Abant Izzet Baysal University Health Sciences Faculty Receives: Other: Observational | |
| Healthy Group | Volunteer healthy individuals with similar demographic characteristics and without any diagnosed disease will be recruited Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragm Thickness
Diaphragm thickness will be measured by ultrasound. Diaphragm thickness will be measured twice, when the person fully exhales and fully fills their lungs with air. Diaphragm thickness will be measured at the 8th or 9th intercostal space. Decreased diaphragm thickness indicate impaired respiratory muscle function; being in the normal range indicates good respiratory muscle function.
Measured: 5 minutes
Diaphragm Mobility
Diaphragm mobility will be measured by ultrasound. Diaphragm mobility will be done by using the total amount of movement of the diaphragm until the individual breathes completely from the point of exhalation. Diaphragm mobility will be performed at the intersection of the medial axillary line and the costal line. Decreased diaphragm mobility indicate impaired respiratory muscle function; being in the normal range indicates good respiratory muscle function.
Measured: 5 minutes
Secondary outcomes (16)
Measurement of Maximal Inspiratory Pressure
Maximal Inspiratory Pressure will be measured with an intraoral pressure measuring device. Maximal Inspiratory Pressure reflects respiratory muscle strength. An increase in Maximal Inspiratory Pressure indicates high respiratory muscle strength; A low Maximal Inspiratory Pressure value indicates respiratory muscle weakness.
Measured: 5 minutes
Incremental Threshold Load Endurance Test
Respiratory muscle endurance will be measured with an incremental threshold load respiratory muscle endurance test. The respiratory muscle endurance test will be performed using a respiratory muscle training device. Endurance test is performed by breathing rapidly and deeply against the respiratory muscle training device of the individual. The individual should continue the test as long as possible. A high respiratory muscle endurance score indicates good respiratory muscle function; A low score indicates respiratory muscle dysfunction.
Measured: 10 minutes
Pulmonary Function Test
Pulmonary function test will be performed with a spirometer according to the criteria of the American Thoracic Society and the European Respiratory Society. While the decrease in pulmonary function test parameters shows worsening of lung functions; parameters in the normal range indicate good lung functions.
Measured: 5 minutes
Six Minute Walk Test
The six minute walk test will be used to evaluate functional exercise capacity. The individual will be asked to walk as fast as possible throughout the test. High walking distance indicates good exercise capacity; A low walking distance indicates a decrease in exercise capacity.
Measured: 10 minutes
Body Composition: Lean Body Mass Percentage
The lean body mass percentage of the individual will be determined by Bioelectrical Impedance Analysis. The measurement will be made by the individual standing on the device with bare feet and waiting. If the lean body mass percentage values are in the normal range, the body composition is normal; lean body mass percentage low values indicate deterioration of body composition.
Measured: 2 minutes
International Physical Activity Assessment Questionnaire
Physical activity level will be assessed with the short form of the International Physical Activity Assessment Questionnaire. The short form of the International Physical Activity Assessment Questionnaire consists of seven questions. A high questionnaire score indicates a high level of physical activity; A low score indicates physical inactivity.
Measured: 2 minutes
Chronic Obstructive Pulmonary Disease Assessment Test (CAT)
Chronic Obstructive Pulmonary Disease Assessment Test is an eight-item scale measuring health status in Chronic Obstructive Pulmonary Disease. This scale is used to determine the health status of individuals with Chronic Obstructive Pulmonary Disease all over the world. Each question is scored between 0-5 and a total score between 0 and 40 is given. A score of 0 represents the best and a score of 40 represents the worst state of health.
Measured: 2 minutes
Modified Medical Research Council Dyspnea Scale
It is a 5-item scale scored between 0-4 for individuals' shortness of breath. Evaluates dyspnea and activity limitation in individuals with chronic obstructive pulmonary disease. An increase in the score indicates an increase in shortness of breath.
Measured: 2 minutes
Modified Borg Scale (MBS)
In this scale, in which the perception of shortness of breath at rest and during exercise will be evaluated, scoring varies between 0-10 points, although high scores indicate high breathlessness and fatigue.
Measured: 2 minutes
Trunk Lateral Flexion Test:
Lateral flexion flexibility is measured with the trunk lateral flexion test. While standing, the arms are held in an upright position with the feet parallel to the body and feet shoulder-width apart. First of all, the distance between the point where the right 3rd finger tip is located and the point where the finger tip is located after right lateral flexion is checked. The distance between the start point and the end point is recorded. The test is repeated three times and the best measurement is recorded as the result. A high distance indicates good trunk flexibility; The low distance indicates that the trunk flexibility is insufficient.
Measured: 1 minute
Back Scratching Test
In the back scratch test, the palmar side of the upper hand and the back of the lower hand should be placed on the back and the distance of the third fingers to each other should be recorded. The test is repeated three times and the best result is considered the test result. If the distance is too much, it shows that the flexibility is bad; A low distance indicates good flexibility.
Measured: 1 minute
Sit-Reach Test
In the sit-reach test, individuals are seated on a flat surface and the individual's feet are made to rest flat on the test bench. Then, the individual is asked to reach forward as much as possible. The test result is obtained by measuring the distance between the tip of the third finger and the foot. During the test, the individual is expected to wait 2-3 seconds at the last point and the test is repeated 3 times to record the best result. A high distance indicates good flexibility; If the distance is low, it indicates that the flexibility is bad.
Measured: 1 minute
30 Second Modified Push Up Test
A 30 second modified push up test will be used to evaluate the upper body muscle strength and endurance of individuals. The individual, whose hands and knees are in contact with the floor, and whose knees and elbows are flexed on the mat, is asked to push his body backwards by extending his elbows without disturbing the flexion of the knees. The number of correct movements in 30 seconds will be recorded as the test result. A high number indicates good upper extremity muscle strength and endurance; A low number indicates poor upper extremity muscle strength and endurance.
Measured: 1 minute
Sit Up Test
The 30-second sit-up test will be used to evaluate the strength and endurance of the abdominal muscles of the individuals. Individuals are asked to lock their hands on the nape in supine, hip and knee flexion, with the plantar face of the foot on the ground (hooked position), and starting from this position, individuals are asked to flex their trunk as much as possible until the scapula is out of contact with the ground. The number of trunk flexions for 30 seconds is recorded. A high number indicates good trunk muscle strength and endurance; A low number indicates poor trunk muscle strength and endurance.
Measured: 1 minute
Sit to Stand Test
Sit and stand test can be performed to evaluate lower extremity muscle strength and endurance. Individuals are asked to cross their arms over their shoulders and sit and stand up for 30 seconds, and the number of sitting and standing is recorded. A high number indicates good lower extremity muscle strength and endurance; A low number indicates poor lower extremity muscle strength and endurance.
Measured: 1 minute
Hand Grip Strength
Hand grip dynamometer is used to measure hand grip strength. Measurements are made three times on the left and right sides of the individual in a sitting position, shoulder adduction, elbow 90° flexion, and forearm neutral position. A high value indicates that the hand grip strength is good; A low value indicates a low hand grip strength.
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start12 Jul 2021
- Primary completion27 Sep 2021
- Study completion18 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eylem TÜTÜN YÜMİN, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04995510
- Sponsor's protocol ID
- AIBU-FTR-ETY-01
- Status last verified
- Nov 2021
- First submitted
- 10 Jul 2021
- Last updated
- 16 Nov 2021
- 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 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Respiratory Muscle Function, Diaphragm Thickness and Health Related Physical Fitness Parameters in Chronic Obstructive Pulmonary Disease Individuals
- ClinicalTrials.gov ID
- NCT04995510
- Acronym / sponsor ID
- AIBU-FTR-ETY-01
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, diaphragm thickness, respiratory muscle function, body composition, physical fitness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 27 Sep 2021 (actual)
- Study completion
- 18 Dec 2021 (estimated)
- First posted
- 9 Aug 2021 (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.
In the literature, studies evaluating respiratory muscle function, diaphragm thickness and health-related physical fitness parameters together are insufficient in individuals with chronic obstructive pulmonary disease. In the thesis study, it is thought that the respiratory muscle function, diaphragm thickness, health-related physical fitness parameters, physical activity and lung functions of individuals with chronic obstructive pulmonary disease can be evaluated together to contribute to the literature. The aim of this study is to evaluate diaphragm thickness, respiratory muscle strength, endurance, body composition, aerobic exercise capacity, upper and lower extremity muscle strength and endurance, grip strength, flexibility in individuals with chronic obstructive pulmonary disease and compare them with the healthy group.
Detailed description
Breathing is the exchange of oxygen and carbon dioxide gases with inspiration (breathing in) and expiration (breathing) in order to maintain the optimum oxygen level in arterial blood. Respiration takes place through respiratory muscles. While inspiration takes place through the diaphragm and accessory respiratory muscles; Expiration takes place passively. Respiratory muscle function is determined by evaluating respiratory muscle strength and respiratory muscle endurance together. respiratory muscle dysfunction; It is a decrease in respiratory muscle strength, endurance, or both, caused by factors such as elongated diaphragm fibers, increased respiratory workload, changes in muscle mass and abdominal weight. Today, respiratory muscle strength are widely used in the evaluation of respiratory muscle function. However, evaluation of respiratory muscle endurance is more effective than respiratory muscle strength in the evaluation of submaximal respiratory muscle contraction, which is valid for daily activities, and in the clinical, functional and prognostic evaluation of respiratory muscles. In chronic obstructive pulmonary disease, respiratory muscle function is associated with pulmonary functions, symptoms, comorbidities, health status, airway obstruction, lung volumes, and physiological disorders. Respiratory muscle dysfunction in chronic obstructive pulmonary disease increases with disease progression. Dysfunction in the diaphragm, which is the most important respiratory muscle, can be evaluated with respiratory muscle strength and endurance, as well as diaphragm thickness. Diaphragm thickness provides information about disease progression in individuals with chronic obstructive pulmonary disease. It is known that diaphragm thickness is associated with respiratory muscle strength and respiratory function parameters in individuals with chronic obstructive pulmonary disease.
The World Health Organization defines health as "a state of complete physical, social and mental well-being and not merely the absence of disease or infirmity". One of the important factors for maintaining health is physical fitness. physical fitness; It is the ability to perform occupational, recreational and daily activities correctly and successfully without fatigue. Physical fitness is also known as the ability to do daily tasks vigorously and carefully, without excessive fatigue, and to allocate sufficient energy for leisure and unexpected emergencies. Physical fitness is divided into two as health-related physical fitness and sports-related physical fitness. While health-related physical fitness parameters are body composition, cardiorespiratory fitness, muscular strength and endurance, flexibility; Sport-related physical fitness parameters are balance, coordination, reaction time, agility, speed and power. Decreased physical fitness in individuals with chronic obstructive pulmonary disease is associated with respiratory problems (such as airway obstruction). It is known that physical fitness is related to the ability to perform physical activity. Low physical fitness occurs in most individuals with chronic obstructive pulmonary disease due to decreased physical activity. There is an important relationship between physical fitness and lung functions.
In the literature, studies evaluating respiratory muscle function, diaphragm thickness and health-related physical fitness parameters together are insufficient in individuals with chronic obstructive pulmonary disease. In the thesis study, which is planned to be done, it is thought that the respiratory muscle function, diaphragm thickness, health-related physical fitness parameters, physical activity and lung functions of individuals with chronic obstructive pulmonary disease can be evaluated together to contribute to the literature.
The aim of this study is to evaluate diaphragm thickness, respiratory muscle strength, endurance, body composition, aerobic exercise capacity, upper and lower extremity muscle strength and endurance, grip strength, flexibility in individuals with chronic obstructive pulmonary disease and compare them with the healthy group.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Obstructive Pulmonary Disease Group | – | Other: ObservationalIndividuals diagnosed with chronic obstructive pulmonary disease by ''Bolu Abant Izzet Baysal University'' Faculty of Medicine, Department of Chest Diseases and referred to the Physiotherapy and Rehabilitation Department of Bolu Abant Izzet Baysal University Health Sciences Faculty |
| Healthy Group | – | Other: ObservationalVolunteer healthy individuals with similar demographic characteristics and without any diagnosed disease will be recruited |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic Obstructive Pulmonary Disease (COPD) is a common, preventable, and treatable disease characterized by persistent airflow limitation, usually progressive, associated with an increased chronic inflammatory response of the airways and lung to noxious gases and particles. In addition, healthy individuals in a similar age range without a diagnosed disease and symptoms will be included in the study.
Key inclusion criteria (8 listed)
- Individuals diagnosed with chronic obstructive pulmonary disease
- Be between the ages of 40-65
- No medication changes due to acute exacerbation for at least three weeks
- Be stable
- Volunteering to participate in research
Key exclusion criteria (11 listed)
- Those with a history of chronic obstructive pulmonary disease exacerbations
- Individuals with orthopedic disease
- Individuals with neurological disease
- Individuals with other co-existing lung and systemic diseases other than chronic obstructive pulmonary disease
- Those who have had major surgery in the past few months
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 |
|---|---|---|
| ObservationalTo evaluate your chronic obstructive pulmonary disease with Chronic Obstructive Pulmonary Disease assessment test, respiratory muscle strength with intraoral pressure measurement device, respiratory muscle endurance with increasing threshold load respiratory muscle endurance test, diaphragm thickness with ultrasound device, cardiorespiratory fitness with 6 Minute Walk Test, flexibility trunk lateral flexion test , back scratch test and sit and lie down test, muscle strength and endurance will be evaluated with push-up test, sit-up test, sit and stand test and hand grip strength, body composition will be evaluated by bioelectrical impedance analysis, physical activity will be questioned with the International Physical Activity Assessment Questionnaire, shortness of breath with the Mmrc Dyspnea Scale, and perception of fatigue and shortness of breath with the Modified Borg Scale. | Other | Chronic Obstructive Pulmonary Disease Group, Healthy Group |
Primary outcome
Diaphragm Thickness
Time frame: 5 minutes
Diaphragm thickness will be measured by ultrasound. Diaphragm thickness will be measured twice, when the person fully exhales and fully fills their lungs with air. Diaphragm thickness will be measured at the 8th or 9th intercostal space. Decreased diaphragm thickness indicate impaired respiratory muscle function; being in the normal range indicates good respiratory muscle function.
Diaphragm Mobility
Time frame: 5 minutes
Diaphragm mobility will be measured by ultrasound. Diaphragm mobility will be done by using the total amount of movement of the diaphragm until the individual breathes completely from the point of exhalation. Diaphragm mobility will be performed at the intersection of the medial axillary line and the costal line. Decreased diaphragm mobility indicate impaired respiratory muscle function; being in the normal range indicates good respiratory muscle function.
16 secondary outcomes
Measurement of Maximal Inspiratory Pressure
Time frame: 5 minutes
Incremental Threshold Load Endurance Test
Time frame: 10 minutes
Pulmonary Function Test
Time frame: 5 minutes
Six Minute Walk Test
Time frame: 10 minutes
Body Composition: Lean Body Mass Percentage
Time frame: 2 minutes
International Physical Activity Assessment Questionnaire
Time frame: 2 minutes
Chronic Obstructive Pulmonary Disease Assessment Test (CAT)
Time frame: 2 minutes
Modified Medical Research Council Dyspnea Scale
Time frame: 2 minutes
Modified Borg Scale (MBS)
Time frame: 2 minutes
Trunk Lateral Flexion Test:
Time frame: 1 minute
Back Scratching Test
Time frame: 1 minute
Sit-Reach Test
Time frame: 1 minute
30 Second Modified Push Up Test
Time frame: 1 minute
Sit Up Test
Time frame: 1 minute
Sit to Stand Test
Time frame: 1 minute
Hand Grip Strength
Time frame: 1 minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Abant Izzet Baysal University 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 8 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: status not confirmed, as of the sponsor's last update on 16 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eylem TÜTÜN YÜMİN, Assoc. Prof. (05056763191, eylemtutun78@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragm Thickness (time frame: 5 minutes). The study lists 2 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 Nov 2021.