Chronic Obstructive Pulmonary DiseaseNCT05005533
The Effect of Respiratory Muscle Strength and Functional Capacity on Posture and Balance
An observational study of Chronic Obstructive Pulmonary Disease, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
As a result of the study, inspiratory muscle strength, posture and physical performance evaluations of individuals with Chronic Obstructive Pulmonary Disease will be made, suggestions will be made to help individual postural smoothness and improve physical performance. Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Observational
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2021to 15 May 2023
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Chronic obstructive pulmonary disease is a common, preventable and treatable disease characterized by persistent respiratory symptoms and airway limitation due to airway and/or alveolar abnormality resulting from exposure to harmful gases or particles and many factors that cause abnormal lung development.
Who may be able to join
- Being diagnosed with Chronic Obstructive Pulmonary Disease according to the Global Initiative for Chronic Obstructive Lung Disease criteria
- Not having vision, hearing and speech problems
- Volunteering to participate in the research
Who cannot join
- Have had major surgery in the past few months
- History of recurrent significant clinical infection
- Having cognitive problems
- Unstable angina, previous myocardial infarction (MI),
- Severe congestive heart failure resistant to medical treatment,
- Having uncontrolled hypertension,
Show all 9Show fewer
- Get cancer
- Having neurological or musculoskeletal diseases with functional limitations
- Having suffered an injury, such as a sprain, sprain or fracture of the lower extremity in the last 6 months, unable to perform independent ambulation
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: The Effect of Respiratory Muscle Strength and Functional Capacity on Posture and Balance in Individuals With Different Phenotypes of Chronic Obstructive Pulmonary Disease
As a result of the study, inspiratory muscle strength, posture and physical performance evaluations of individuals with Chronic Obstructive Pulmonary Disease will be made, suggestions will be made to help individual postural smoothness and improve physical performance.
Read the detailed description
Chronic Obstructive Pulmonary Disease is a multifaceted disease that results from the interaction between genetic susceptibility and exposure to environmental stimuli. Due to the slow progression and chronic nature of the disease, it creates a growing disease burden on the individual. Considering the data of the Turkish Statistical Institute, the third most common cause of death in Turkey in 2010, 2011 and 2012 was respiratory system diseases. 61.5% of respiratory system deaths in 2012 were due to Chronic Obstructive Pulmonary Disease. Due to the progressive airway obstruction that occurs in Chronic Obstructive Pulmonary Disease, the level of inspiratory muscle strength is restricted and there is an increasing deterioration in the level of functional performance. However, with increasing age, postural problems can be observed in individuals with Chronic Obstructive Pulmonary Disease. Postural problems such as rounded shoulders, increase in thoracic kyphosis and muscle shortness can be observed especially in patients who start to use the auxiliary respiratory muscles continuously due to inspiratory muscle strength. There are few articles investigating the changes in posture, physical performance and inspiratory muscles with the addition of a chronic disease such as Chronic Obstructive Pulmonary Disease to the normal aging process. For this reason, a study titled "The effect of respiratory muscle strength and functional capacity on posture and balance in individuals with Chronic Obstructive Pulmonary Disease with Different Phenotypes" was planned.
As a result of the study, inspiratory muscle strength, posture and physical performance evaluations of individuals with Chronic Obstructive Pulmonary Disease will be made, and suggestions will be made to help individual postural smoothness and improve physical performance.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Observational
- Keywords
- Chronic Obstructive Pulmonary Disease, Respiratory Muscle Strength, Posture, Balance, Functional Capacity
- 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
Chronic Obstructive Pulmonary Disease Severity of Individuals by Chronic Obstructive Pulmonary Disease Assessment Test, shortness of breath Modified Medical Research Council scale, cough related quality of life Leicester Cough Questionnaire, respiratory muscle strength with Maximum Inspiratory and Expiratory Pressure, Posture with Spinal Mouse device, pain with Visual Analog Scale, severity of fatigue Fatigue Physical performance of the lower extremities will be evaluated with the Short Physical Performance Test, functional mobility will be evaluated with the Time Up and Go Test, and balance will be evaluated with the Biodex Balance System
| Study group | Role | What they receive |
|---|---|---|
| Mild and Moderate Severe Group | Individuals with Chronic Obstructive Pulmonary Disease with a Forced Expiratory Volume greater than 50% of the expected value Receives: Other: Observational | |
| Severe and Very Severe Group | Individuals with Chronic Obstructive Pulmonary Disease whose Forced Expiratory Volume is less than 50% of the expected value Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Inspiratory Pressure
Respiratory muscle strength will be assessed by maximal inspiratory pressure. Values in the normal range indicate normal respiratory muscle strength, low values indicate decreased respiratory muscle strength.
Measured: 5 minutes
Secondary outcomes (9)
Posture Assessment
Posture assessment of individuals will be done with the Spinal Mouse device. Individuals will be asked to distribute their weight equally on both lower extremities as much as possible and to stand symmetrically. The angular deviation between each SPINE will be calculated as an angle. While the high angle of deviation indicates that the posture is bad; A low angle of deviation indicates a good posture
Measured: 5 minutes
Biodex Balance System
Balance assessment will be evaluated with the Biodex Balance System. A high values indicates poor balance, and a low values indicates good balance.
Measured: 5 minutes
Time Up and Go Test
Time Up and Go Test is a balance test that is frequently used to evaluate the functional mobility of individuals. High times indicate impaired functional mobility; low times indicate good functional mobility.
Measured: 2 minutes
Short Physical Performance Test
The physical performance of the lower extremities of the individuals will be evaluated with the Short Physical Performance Test. High values indicate deterioration of physical performance; low values indicate good physical performance.
Measured: 5 minutes
Chronic Obstructive Pulmonary Disease Assessment Test
Chronic Obstructive Pulmonary Disease symptoms are assessed with the Chronic Obstructive Pulmonary Disease Evaluation Test. High values indicate poor health; low values indicate good health
Measured: 2 minutes
Modified Medical Research Council Scale
The breath assessment test will be evaluated with the Modified Medical Research Council Scale. High values indicate high dyspnea; low values indicate low dyspnea.
Measured: 2 minutes
Leicester Cough Questionnaire
The cough related quality of life questionnaire will be assessed by the Leicester Cough Questionnaire. Low values indicate poor quality of life associated with cough; high values indicate good quality of life associated with cough
Measured: 2 minutes
Visual Analog Scale
Pain intensity will be evaluated with a visual analog scale. While high values indicate increased pain intensity; low values indicate low pain intensity
Measured: 2 minutes
Fatigue Severity Scale
Fatigue will be evaluated with the Fatigue Severity Scale. High values indicate increased fatigue severity; lower values indicate lower fatigue severity
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start15 Mar 2021
- Primary completion15 Feb 2023
- Study completion15 May 2023 (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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ceyhun Topcuoğlu, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005533
- Sponsor's protocol ID
- AIBU-FTR-CT-05
- Status last verified
- Mar 2023
- First submitted
- 7 Aug 2021
- Last updated
- 29 Mar 2023
- 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 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Respiratory Muscle Strength and Functional Capacity on Posture and Balance in Individuals With Different Phenotypes of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT05005533
- Acronym / sponsor ID
- AIBU-FTR-CT-05
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, Respiratory Muscle Strength, Posture, Balance, Functional Capacity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 15 May 2023 (estimated)
- First posted
- 13 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.
As a result of the study, inspiratory muscle strength, posture and physical performance evaluations of individuals with Chronic Obstructive Pulmonary Disease will be made, suggestions will be made to help individual postural smoothness and improve physical performance.
Detailed description
Chronic Obstructive Pulmonary Disease is a multifaceted disease that results from the interaction between genetic susceptibility and exposure to environmental stimuli. Due to the slow progression and chronic nature of the disease, it creates a growing disease burden on the individual. Considering the data of the Turkish Statistical Institute, the third most common cause of death in Turkey in 2010, 2011 and 2012 was respiratory system diseases. 61.5% of respiratory system deaths in 2012 were due to Chronic Obstructive Pulmonary Disease. Due to the progressive airway obstruction that occurs in Chronic Obstructive Pulmonary Disease, the level of inspiratory muscle strength is restricted and there is an increasing deterioration in the level of functional performance. However, with increasing age, postural problems can be observed in individuals with Chronic Obstructive Pulmonary Disease. Postural problems such as rounded shoulders, increase in thoracic kyphosis and muscle shortness can be observed especially in patients who start to use the auxiliary respiratory muscles continuously due to inspiratory muscle strength. There are few articles investigating the changes in posture, physical performance and inspiratory muscles with the addition of a chronic disease such as Chronic Obstructive Pulmonary Disease to the normal aging process. For this reason, a study titled "The effect of respiratory muscle strength and functional capacity on posture and balance in individuals with Chronic Obstructive Pulmonary Disease with Different Phenotypes" was planned.
As a result of the study, inspiratory muscle strength, posture and physical performance evaluations of individuals with Chronic Obstructive Pulmonary Disease will be made, and suggestions will be made to help individual postural smoothness and improve physical performance.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mild and Moderate Severe Group | – | Other: ObservationalIndividuals with Chronic Obstructive Pulmonary Disease with a Forced Expiratory Volume greater than 50% of the expected value |
| Severe and Very Severe Group | – | Other: ObservationalIndividuals with Chronic Obstructive Pulmonary Disease whose Forced Expiratory Volume is less than 50% of the expected value |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic obstructive pulmonary disease is a common, preventable and treatable disease characterized by persistent respiratory symptoms and airway limitation due to airway and/or alveolar abnormality resulting from exposure to harmful gases or particles and many factors that cause abnormal lung development.
Key inclusion criteria (3 listed)
- Being diagnosed with Chronic Obstructive Pulmonary Disease according to the Global Initiative for Chronic Obstructive Lung Disease criteria
- Not having vision, hearing and speech problems
- Volunteering to participate in the research
Key exclusion criteria (9 listed)
- Have had major surgery in the past few months
- History of recurrent significant clinical infection
- Having cognitive problems
- Unstable angina, previous myocardial infarction (MI),
- Severe congestive heart failure resistant to medical treatment,
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 |
|---|---|---|
| ObservationalChronic Obstructive Pulmonary Disease Severity of Individuals by Chronic Obstructive Pulmonary Disease Assessment Test, shortness of breath Modified Medical Research Council scale, cough related quality of life Leicester Cough Questionnaire, respiratory muscle strength with Maximum Inspiratory and Expiratory Pressure, Posture with Spinal Mouse device, pain with Visual Analog Scale, severity of fatigue Fatigue Physical performance of the lower extremities will be evaluated with the Short Physical Performance Test, functional mobility will be evaluated with the Time Up and Go Test, and balance will be evaluated with the Biodex Balance System | Other | Mild and Moderate Severe Group, Severe and Very Severe Group |
Primary outcome
Maximal Inspiratory Pressure
Time frame: 5 minutes
Respiratory muscle strength will be assessed by maximal inspiratory pressure. Values in the normal range indicate normal respiratory muscle strength, low values indicate decreased respiratory muscle strength.
9 secondary outcomes
Posture Assessment
Time frame: 5 minutes
Biodex Balance System
Time frame: 5 minutes
Time Up and Go Test
Time frame: 2 minutes
Short Physical Performance Test
Time frame: 5 minutes
Chronic Obstructive Pulmonary Disease Assessment Test
Time frame: 2 minutes
Modified Medical Research Council Scale
Time frame: 2 minutes
Leicester Cough Questionnaire
Time frame: 2 minutes
Visual Analog Scale
Time frame: 2 minutes
Fatigue Severity Scale
Time frame: 2 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- 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 3 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 29 Mar 2023. 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. (+90 505 676 31 91, eylemtutun78@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Inspiratory Pressure (time frame: 5 minutes). 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 Mar 2023.