CopdNCT04803656
Assessment of Pulmonary Functions and Peripheral Muscle Strength of COPD Patients in Different GOLD Stages
A study testing Assessment of COPD patients in people with Copd, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this research was to examine the respiratory functions, respiratory muscle strength and peripheral muscle strength of patients with COPD in different groups and to evaluate their correlation with the duration and prognosis of the disease in COPD. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Copd
- What is being tested?
- Assessment of COPD patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Feb 2019to 19 Jun 2019
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being in COPD stable period and over the age of 40,
- The absence of abnormal laboratory findings,
- Not having a mental problem that prevents filling the questionnaires to be used in the study, - The absence of any other respiratory disease such as asthma,
- Giving the informed consent.
Who cannot join
- COPD exacerbation (hospitalization with acute exacerbation in the last 15 days),
- Presence of cognitive impairment,
- Pregnancy status,
- Ischemic heart disease,
- Kyphoscoliosis and advanced postural disorder,
- Orthopedic problems and amputation surgery,
Show all 11Show fewer
- Emphysema, bullous lung disease,
- Presence of bronchiectasis,
- Previous thoracic surgery history,
- Presence of lung cancer,
- Advanced heart failure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pulmonary Functions and Peripheral Muscle Strength and Their Relationship With Disease Duration and Prognosis in Patients With Different COPD Stages
The purpose of this research was to examine the respiratory functions, respiratory muscle strength and peripheral muscle strength of patients with COPD in different groups and to evaluate their correlation with the duration and prognosis of the disease in COPD.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is a common disease characterized by airway obstruction against harmful particles and gases in the airway and lungs, and is progressive, treatable and preventable.
The severity of the disease in COPD is determined according to the GOLD (Global Initiative for Chronic Obstructive Lung Disease) guidelines (2). While determining the severity of airway obstruction with the patient's spirometric values in COPD; Combined COPD assessment is made with symptomatic evaluation, number of exacerbations and hospitalizations. Airway restriction is numerically (GOLD 1-4), symptom evaluation and exacerbation risk combined with letter grouping (Group A-D).
There is a loss of respiratory and peripheral muscle strength in COPD patients. A mixture of various local and systemic causes was responsible for respiratory muscle dysfunction in COPD. Immobility, systemic inflammation, hypoxia of the tissue, oxidative stress and increased apoptosis of the skeletal muscle have been identified as possible pathogenic factors for loss of peripheral muscle strength in COPD patients.
it was aimed to evaluate the respiratory functions, respiratory muscle strength and peripheral muscle strength of patients with different COPD groups clinically and to evaluate their correlation with the duration and prognosis of the disease.
- Conditions
- Copd
- Being tested
- Assessment of COPD patients
- Keywords
- COPD, Pulmonary functions, Respiratory muscle strength, Peripheral muscle strength
- 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.
Assessment of COPD patientsOther
Assessments explained in the arm section were made as described in one session.
| Study group | Role | What they receive |
|---|---|---|
| Assesment | Other | Demographic information of all subjects (age, gender, educational status, occupation, body weight, height, body mass index), clinical (diagnosis period) and medical status, personal history and family history, COPD stage, COPD Assessment Test (CAT) score, emergency and hospital admissions numbers in the last 3 months, exacerbation and hospitalization numbers in the last one year were recorded. Respiratory and peripheral muscle strengths are evaluated. Also pulmonary functions test results obtained. Receives: Other: Assessment of COPD patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Muscle Strength
It is a non-invasive test that indirectly demonstrates respiratory muscle strength with maximal inspiratory pressure (PImax) and maximal expiratory pressure (PEmax).Test were carried out according to American Thoracic Society (ATS) / European Respiratory Society (ERS) criteria.
Measured: 10 minutes after obtaining socio-demographic information (It was done between the 10th and 20th minutes of the assessment).
Peripheral Muscle Strength Assessment-Upper extremity
Upper extremity: For grip strength test a manual hydraulic dynamometer was used according to the recommendations of the American Association of Hand Therapists (AETD). The patients were measured in sitting position, shoulder adduction at 90 °, elbow flexion, forearm in pronosupination, neutral and wrist joints in neutral position. Three consecutive measurements were obtained by giving 60-second rest breaks between measurements. The result obtained from the average of three measurements was recorded.
Measured: 25 minutes after obtaining socio-demographic information. After the respiratory muscle strength evaluation, the patients were rested for 5 minutes (It was done between the 25th and 35th minutes of the assessment).
Peripheral Muscle Strength Assessment-Lower extremity
- Quadriceps femoris strength was evaluated for knee extension. M. Hamstring strength was evaluated for knee flexion. The test was applied with the "make test" technique that requires isometric contraction. Participant was asked to maintain maximum isometric contraction for 5 seconds, and the average of 3 consecutive maximum contraction measurements performed at 30-second intervals was recorded.
Measured: 40 minutes after obtaining socio-demographic information. After Upper extremity muscle strength evaluation patients were rested for five minutes (It was done between the 40th and 55th minutes of the assessment)
Pulmonary Function Test (PFT) results
The PFT results of patients' performed during their routine controls taken into consideration. The percentages of the predicted values (percent) for forced expiratory volume in one second (FEV1), forced vital capacity (FVC), FEV1/FVC, mid-expiratory flow rate (MEF25-75) and peak expiratory flow (PEF) were used for statistical analysis.
Measured: 55 minutes after obtaining socio-demographic information.
Secondary outcomes (3)
Duration of the disease
Diagnosis year of the patient were recorded.
Measured: After the permission of patients, in the first 10 minutes of assessment while obtaining socio-demographic information of patients.
Exacerbation numbers in last one year
Exacerbation numbers in last one year of the patients were recorded.
Measured: After the permission of patients, in the first 10 minutes of assessment while obtaining socio-demographic information of patients.
Hospitalization numbers in last one year
Hospitalization numbers in last one year of the patients were recorded.
Measured: After the permission of patients, in the first 10 minutes of assessment while obtaining socio-demographic information of patients.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start8 Feb 2019
- Primary completion23 May 2019
- Study completion19 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CopdStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- COPD patients: Respiratory muscle strength, peripheral muscle strength in both upper and lower extremity were evaluated. Pulmonary function tests obtained during routine controls of patients.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Begum Unlu, PT, MSc, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803656
- Sponsor's protocol ID
- SAG-C-YLP-131217-0652
- Status last verified
- Mar 2021
- First submitted
- 9 Mar 2021
- Last updated
- 18 Mar 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 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Functions and Peripheral Muscle Strength and Their Relationship With Disease Duration and Prognosis in Patients With Different COPD Stages
- ClinicalTrials.gov ID
- NCT04803656
- Acronym / sponsor ID
- SAG-C-YLP-131217-0652
- Conditions
- Copd
- Keywords
- COPD, Pulmonary functions, Respiratory muscle strength, Peripheral muscle strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 8 Feb 2019 (actual)
- Primary completion
- 23 May 2019 (actual)
- Study completion
- 19 Jun 2019 (actual)
- First posted
- 18 Mar 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.
The purpose of this research was to examine the respiratory functions, respiratory muscle strength and peripheral muscle strength of patients with COPD in different groups and to evaluate their correlation with the duration and prognosis of the disease in COPD.
Detailed description
Chronic obstructive pulmonary disease (COPD) is a common disease characterized by airway obstruction against harmful particles and gases in the airway and lungs, and is progressive, treatable and preventable.
The severity of the disease in COPD is determined according to the GOLD (Global Initiative for Chronic Obstructive Lung Disease) guidelines (2). While determining the severity of airway obstruction with the patient's spirometric values in COPD; Combined COPD assessment is made with symptomatic evaluation, number of exacerbations and hospitalizations. Airway restriction is numerically (GOLD 1-4), symptom evaluation and exacerbation risk combined with letter grouping (Group A-D).
There is a loss of respiratory and peripheral muscle strength in COPD patients. A mixture of various local and systemic causes was responsible for respiratory muscle dysfunction in COPD. Immobility, systemic inflammation, hypoxia of the tissue, oxidative stress and increased apoptosis of the skeletal muscle have been identified as possible pathogenic factors for loss of peripheral muscle strength in COPD patients.
it was aimed to evaluate the respiratory functions, respiratory muscle strength and peripheral muscle strength of patients with different COPD groups clinically and to evaluate their correlation with the duration and prognosis of the disease.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- COPD patients: Respiratory muscle strength, peripheral muscle strength in both upper and lower extremity were evaluated. Pulmonary function tests obtained during routine controls of patients.
| Arm | Type | Receives |
|---|---|---|
| Assesment | Other | Other: Assessment of COPD patientsDemographic information of all subjects (age, gender, educational status, occupation, body weight, height, body mass index), clinical (diagnosis period) and medical status, personal history and family history, COPD stage, COPD Assessment Test (CAT) score, emergency and hospital admissions numbers in the last 3 months, exacerbation and hospitalization numbers in the last one year were recorded. Respiratory and peripheral muscle strengths are evaluated. Also pulmonary functions test results obtained. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being in COPD stable period and over the age of 40,
- The absence of abnormal laboratory findings,
- Not having a mental problem that prevents filling the questionnaires to be used in the study, - The absence of any other respiratory disease such as asthma,
- Giving the informed consent.
Key exclusion criteria (11 listed)
- COPD exacerbation (hospitalization with acute exacerbation in the last 15 days),
- Presence of cognitive impairment,
- Pregnancy status,
- Ischemic heart disease,
- Kyphoscoliosis and advanced postural disorder,
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 |
|---|---|---|
| Assessment of COPD patientsAssessments explained in the arm section were made as described in one session. | Other | Assesment |
Primary outcome
Respiratory Muscle Strength
Time frame: 10 minutes after obtaining socio-demographic information (It was done between the 10th and 20th minutes of the assessment).
It is a non-invasive test that indirectly demonstrates respiratory muscle strength with maximal inspiratory pressure (PImax) and maximal expiratory pressure (PEmax).Test were carried out according to American Thoracic Society (ATS) / European Respiratory Society (ERS) criteria.
Peripheral Muscle Strength Assessment-Upper extremity
Time frame: 25 minutes after obtaining socio-demographic information. After the respiratory muscle strength evaluation, the patients were rested for 5 minutes (It was done between the 25th and 35th minutes of the assessment).
Upper extremity: For grip strength test a manual hydraulic dynamometer was used according to the recommendations of the American Association of Hand Therapists (AETD). The patients were measured in sitting position, shoulder adduction at 90 °, elbow flexion, forearm in pronosupination, neutral and wrist joints in neutral position. Three consecutive measurements were obtained by giving 60-second rest breaks between measurements. The result obtained from the average of three measurements was recorded.
Peripheral Muscle Strength Assessment-Lower extremity
Time frame: 40 minutes after obtaining socio-demographic information. After Upper extremity muscle strength evaluation patients were rested for five minutes (It was done between the 40th and 55th minutes of the assessment)
M. Quadriceps femoris strength was evaluated for knee extension. M. Hamstring strength was evaluated for knee flexion. The test was applied with the "make test" technique that requires isometric contraction. Participant was asked to maintain maximum isometric contraction for 5 seconds, and the average of 3 consecutive maximum contraction measurements performed at 30-second intervals was recorded.
Pulmonary Function Test (PFT) results
Time frame: 55 minutes after obtaining socio-demographic information.
The PFT results of patients' performed during their routine controls taken into consideration. The percentages of the predicted values (percent) for forced expiratory volume in one second (FEV1), forced vital capacity (FVC), FEV1/FVC, mid-expiratory flow rate (MEF25-75) and peak expiratory flow (PEF) were used for statistical analysis.
3 secondary outcomes
Duration of the disease
Time frame: After the permission of patients, in the first 10 minutes of assessment while obtaining socio-demographic information of patients.
Exacerbation numbers in last one year
Time frame: After the permission of patients, in the first 10 minutes of assessment while obtaining socio-demographic information of patients.
Hospitalization numbers in last one year
Time frame: After the permission of patients, in the first 10 minutes of assessment while obtaining socio-demographic information of patients.
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 18 Mar 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.
Begum Unlu, PT, MSc principal investigator
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment of COPD patients in people with Copd, run by Marmara 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 4 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: finished, as of the sponsor's last update on 18 Mar 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?
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?
Respiratory Muscle Strength (time frame: 10 minutes after obtaining socio-demographic information (It was done between the 10th and 20th minutes of the assessment).). The study lists 4 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 18 Mar 2021.