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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).

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 The sponsor has not verified this record for over two years, so it may be out of date.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

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.

Eylem TÜTÜN YÜMİN, Assoc. Prof. contact

05056763191

eylemtutun78@hotmail.com

Ceyhun TOPCUOĞLU, Res. Assist. contact

05356535137

ceyhuntopcuoglu1@gmail.com

Turkey (Türkiye)1 site, 1 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

    Recruiting

Other trials in Turkey (Türkiye)

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.

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 groups in NCT04995510
Study groupRoleWhat they receive
Chronic Obstructive Pulmonary Disease GroupIndividuals 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 GroupVolunteer 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.

  1. 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

  2. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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.

  1. First posted9 Aug 2021
  2. Study start12 Jul 2021
  3. Primary completion27 Sep 2021
  4. Study completion18 Dec 2021 (estimated)

Resources

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)
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

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.

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