CopdCOPDNCT06510686
Effects of Core Stabilization and Inspiratory Muscle Training in Patients With COPD
A study testing İnspiratory muscle training and Core training in people with Copd, run by Mustafa Ertuğrul Yaşa at 1 site in Turkey (Türkiye).
Trial summary
In Chronic Obstructive Pulmonary Disease (COPD), a mismatch develops between the respiratory system's demand and the functional capacity of respiratory muscles due to the combination of local and systemic factors increasing the respiratory workload. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Copd
- What is being tested?
- İnspiratory muscle training and Core training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 5 Jun 2025
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being over 18 years old
- Having a diagnosis of COPD according to the GOLD criteria and being at stage 3 or lower
- Not being in an acute exacerbation period and having at least one month since the last exacerbation
- Being able to walk independently
- Having sufficient mental capacity to understand the tasks in the study (Mini-Mental Test >24)
- Being willing to participate in the study
Who cannot join
- Being a stage 4 COPD patient according to the GOLD criteria
- Having a diagnosis of lung cancer, pulmonary hypertension, and heart failure
- Being in a COPD exacerbation period
- Scoring below 24 on the Mini-Mental Test
- Having any other disease that affects respiratory functions
- Having undergone pulmonary surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Core Stabilization and Inspiratory Muscle Training on Diaphragm Activation, Inspiratory Muscle Strength, Functional Capacity, Respiratory Functions, Physical Activity and Quality of Life in Patients With COPD
In Chronic Obstructive Pulmonary Disease (COPD), a mismatch develops between the respiratory system's demand and the functional capacity of respiratory muscles due to the combination of local and systemic factors increasing the respiratory workload. This results in impaired coordination of muscle groups, leading to muscle dysfunction. Respiratory muscle dysfunction is a significant determinant of life expectancy in COPD. Additionally, respiratory muscles unable to cope with increased workloads lead to impaired respiratory functions and reduced exercise capacity.
It is widely accepted that appropriate training of respiratory muscles can increase their strength, endurance, and their close relationship with lung volume capacities. Besides their role in respiration, respiratory muscles also contribute to postural function and core stabilization. Studies on respiratory muscle training in COPD have primarily focused on inspiratory muscle strength training, neglecting the core stabilization function of respiratory muscles. However, optimal gains in a muscle can only be achieved with training tailored to its functional characteristics. Therefore, a comprehensive training program should be developed considering the multifunctional nature of respiratory muscles. Studies published in healthy individuals and different patient populations demonstrate that core training can improve lung functions. The aim of this study is to compare the effects of inspiratory muscle training and core stabilization training on diaphragm activation, inspiratory muscle strength, functional capacity, respiratory functions, physical activity, and quality of life in individuals with COPD.
- Conditions
- Copd
- Being tested
- İnspiratory muscle training, Core training
- 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.
İnspiratory muscle trainingOther
Also called Normal breath exercises and İnspiratory muscle training
exercises to strengthen inspiratory muscles
Core trainingOther
Also called Normal breath exercises and İnspiratory muscle training and Core Stabilization
exercises to strengthen inspiratory and core muscles
| Study group | Role | What they receive |
|---|---|---|
| İnspiratory muscle training | Other | Inspiratory muscle training during 8 weeks Receives: Other: İnspiratory muscle training |
| Core Stabilization | Other | Inspiratory muscle training and core training during 8 weeks Receives: Other: İnspiratory muscle training; Other: Core training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory Muscle Strength
Maximal Inspiratory Pressure (MIP) (cmH2O),
Measured: 8 weeks
Inspiratory Muscle Activation
surface EMG (TLC from FRC (TLC maneuver)(cmH2O)
Measured: 8 weeks
Respiratory function tests FEV1
Spirometry, FEV1 (lt)
Measured: 8 weeks
Respiratory function tests FVC
Spirometry, FVC (lt)
Measured: 8 weeks
Respiratory function tests PEF
Spirometry, PEF (lt/sn)
Measured: 8 weeks
Respiratory function tests FEV1/FVC
Spirometry, FEV1/FVC %
Measured: 8 weeks
Respiratory function MVV
Spirometry, MVV(L/min)
Measured: 8 weeks
Functional capacity
Six Minute Walking Test (6MVT) (m)
Measured: 8 weeks
Symptoms
MMRC Dyspnea Scale (Scores range from 0 to 4)
Measured: 8 weeks
Secondary outcomes (6)
Physical activity,
IPAQ (MET/minute)
Measured: 8 week
Quality of life Tests
SGRQ (Scores range from 0 to 100)
Measured: 8 week
Core Strength
1 minute sit to stand ( how many times sit and stand during 1 minute)
Measured: 8 week
Core Strength flexion
Mcgill Endurance Tests For Trunk Flexion (sec)
Measured: 8 week
Core Strength extension
Mcgill Endurance Tests For Trunk Extension (sec)
Measured: 8 week
Core Strength side bridge
Mcgill Endurance Tests For Side Bridge (sec)
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start1 Oct 2024
- Primary completion3 May 2025
- Study completion5 Jun 2025
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.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mustafa Ertuğrul Yaşa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mustafa Ertuğrul Yaşa, Gulhane School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510686
- Sponsor's protocol ID
- 2024-183
- Acronym
- COPD
- Status last verified
- Aug 2025
- First submitted
- 3 Jul 2024
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Core Stabilization and Inspiratory Muscle Training on Diaphragm Activation, Inspiratory Muscle Strength, Functional Capacity, Respiratory Functions, Physical Activity and Quality of Life in Patients With COPD
- ClinicalTrials.gov ID
- NCT06510686
- Acronym / sponsor ID
- COPD / 2024-183
- Conditions
- Copd
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Mustafa Ertuğrul YaşaUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 3 May 2025 (actual)
- Study completion
- 5 Jun 2025 (actual)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In Chronic Obstructive Pulmonary Disease (COPD), a mismatch develops between the respiratory system's demand and the functional capacity of respiratory muscles due to the combination of local and systemic factors increasing the respiratory workload. This results in impaired coordination of muscle groups, leading to muscle dysfunction. Respiratory muscle dysfunction is a significant determinant of life expectancy in COPD. Additionally, respiratory muscles unable to cope with increased workloads lead to impaired respiratory functions and reduced exercise capacity.
It is widely accepted that appropriate training of respiratory muscles can increase their strength, endurance, and their close relationship with lung volume capacities. Besides their role in respiration, respiratory muscles also contribute to postural function and core stabilization. Studies on respiratory muscle training in COPD have primarily focused on inspiratory muscle strength training, neglecting the core stabilization function of respiratory muscles. However, optimal gains in a muscle can only be achieved with training tailored to its functional characteristics. Therefore, a comprehensive training program should be developed considering the multifunctional nature of respiratory muscles. Studies published in healthy individuals and different patient populations demonstrate that core training can improve lung functions. The aim of this study is to compare the effects of inspiratory muscle training and core stabilization training on diaphragm activation, inspiratory muscle strength, functional capacity, respiratory functions, physical activity, and quality of life in individuals with COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| İnspiratory muscle training | Other | Other: İnspiratory muscle trainingInspiratory muscle training during 8 weeks |
| Core Stabilization | Other | Other: İnspiratory muscle training, Other: Core trainingInspiratory muscle training and core training during 8 weeks |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Being over 18 years old
- Having a diagnosis of COPD according to the GOLD criteria and being at stage 3 or lower
- Not being in an acute exacerbation period and having at least one month since the last exacerbation
- Being able to walk independently
- Having sufficient mental capacity to understand the tasks in the study (Mini-Mental Test >24)
Key exclusion criteria (6 listed)
- Being a stage 4 COPD patient according to the GOLD criteria
- Having a diagnosis of lung cancer, pulmonary hypertension, and heart failure
- Being in a COPD exacerbation period
- Scoring below 24 on the Mini-Mental Test
- Having any other disease that affects respiratory functions
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 |
|---|---|---|
| İnspiratory muscle trainingAlso: Normal breath exercises and İnspiratory muscle trainingexercises to strengthen inspiratory muscles | Other | Core Stabilization, İnspiratory muscle training |
| Core trainingAlso: Normal breath exercises and İnspiratory muscle training and Core Stabilizationexercises to strengthen inspiratory and core muscles | Other | Core Stabilization |
Primary outcome
Inspiratory Muscle Strength
Time frame: 8 weeks
Maximal Inspiratory Pressure (MIP) (cmH2O),
Inspiratory Muscle Activation
Time frame: 8 weeks
surface EMG (TLC from FRC (TLC maneuver)(cmH2O)
Respiratory function tests FEV1
Time frame: 8 weeks
Spirometry, FEV1 (lt)
Respiratory function tests FVC
Time frame: 8 weeks
Spirometry, FVC (lt)
Respiratory function tests PEF
Time frame: 8 weeks
Spirometry, PEF (lt/sn)
Respiratory function tests FEV1/FVC
Time frame: 8 weeks
Spirometry, FEV1/FVC %
Respiratory function MVV
Time frame: 8 weeks
Spirometry, MVV(L/min)
Functional capacity
Time frame: 8 weeks
Six Minute Walking Test (6MVT) (m)
Symptoms
Time frame: 8 weeks
MMRC Dyspnea Scale (Scores range from 0 to 4)
6 secondary outcomes
Physical activity,
Time frame: 8 week
Quality of life Tests
Time frame: 8 week
Core Strength
Time frame: 8 week
Core Strength flexion
Time frame: 8 week
Core Strength extension
Time frame: 8 week
Core Strength side bridge
Time frame: 8 week
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 5 Sep 2025.
Related trials for Copd
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing İnspiratory muscle training and Core training in people with Copd, run by Mustafa Ertuğrul Yaşa 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 6 inclusion and 6 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 5 Sep 2025. 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?
Inspiratory Muscle Strength (time frame: 8 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.