COPD (Chronic Obstructive Pulmonary Disease)NCT06680960
Investigation of the Effects of Different Exercise Approaches on Clinical Parameters in Chronic Obstructive Pulmonary Disease Patients
A study testing Trunk stabilisation exercises and Respiratory exercises in people with COPD (Chronic Obstructive Pulmonary Disease), run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The beneficial effects of exercise training in individuals with chronic obstructive pulmonary disease (COPD) are well known. Standard exercise training includes structured aerobic exercise training and resistance exercise training programs applied to upper and lower extremity muscle groups. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- Trunk stabilisation exercises and Respiratory exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Having a diagnosis of COPD
- Being between the ages of 40-80
- Being clinically stable (not having had an exacerbation in the last month)
- Being able to cooperate with the tests
- Not participating in any exercise training studies
- Being willing to participate in the study
Who cannot join
- Having other lung or lung involvement diseases other than COPD
- Having uncontrolled hypertension, arrhythmia and a history of myocardial infarction in the last month, unstable angina, advanced heart failure and other cardiac instability conditions
- Being hemodynamically unstable
- Being on noninvasive mechanical ventilation (NIMV) and long-term oxygen therapy (LTOT)
- Having a history of neuromuscular disease, scoliosis, chest wall surgery
- Being pregnant and having a malignancy
- Having an orthopedic or surgical problem that would prevent participation in tests and exercise training
- Not being willing to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effects of Different Exercise Approaches on Exercise Capacity, Muscle Parameters and Quality of Life in Chronic Obstructive Pulmonary Disease Patients
The beneficial effects of exercise training in individuals with chronic obstructive pulmonary disease (COPD) are well known. Standard exercise training includes structured aerobic exercise training and resistance exercise training programs applied to upper and lower extremity muscle groups. No study has been found in the literature that includes a trunk stabilization training program that includes muscles that provide whole body stabilization in COPD patients.
Read the detailed description
The investigators aimed to determine the effects of an aerobic exercise training program, resistance exercise training, and an additional trunk stabilization training program in individuals with COPD.
Individuals diagnosed with COPD between the ages of 40-80 who applied to Ankara Etlik City Hospital Chest Diseases Polyclinic will be included in the study. Data collection tools and exercise training programs will be made by the same researchers. A total of 44 COPD patients, 22 in each group, will be included in the study.
COPD individuals who agree to participate in the study will be randomised electronically using a randomisation program and participants will be divided into two groups.
Group 1: Aerobic exercise training and resistance exercise training and trunk stabilisation strength training Group 2: Aerobic exercise training, resistance exercise training and respiratory exercise training
- Being tested
- Trunk stabilisation exercises, Respiratory exercises
- Keywords
- copd, exercise training, trunk stabilisation, muscle parameters
- 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.
Trunk stabilisation exercisesOther
This exercise program includes aerobic exercise, resistance exercise and trunk stabilisation training for eight weeks.
Respiratory exercisesOther
This exercise program includes aerobic exercise, resistance exercise and respiratory exercise training for eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| Trunk Stabilisation Exercise Group | Active comparator | Not described Receives: Other: Trunk stabilisation exercises |
| Respiratory Exercise Group | Active comparator | Not described Receives: Other: Respiratory exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal exercise capacity
Maximal exercise capacity will be assessed by cardiopulmonary exercise testing (CPET) using a workload protocol of increasing intensity. Monitoring will be provided with 12-lead electrocardiography at rest, during testing and recovery. During CPET, data will be recorded with the "breathe-by-breathe" method through a face mask and a gas analyzer.
Measured: 8 weeks
Secondary outcomes (11)
Forced expiratory volume (FEV1)
It is the volume of air exhaled in the first second from the beginning of the forced vital capacity maneuver. This parameter will be assessed using spirometry (Cosmed Microquark-PC Based Spirometer, Rome, Italy) according to the criteria of the European Respiratory Society (ERS) and the American Thoracic Society (ATS). If this value is below eighty percent, it indicates the presence of airway obstruction.
Measured: 8 weeks
Forced Vital Capacity (FVC)
It is the volume of air exhaled rapidly and forcefully following deep inspiration. Healthy people can normally exhale 80% of their lung volume in 6 seconds or less. In people with severe obstruction, this period may take up to 20 seconds. This parameter will be assessed using spirometry (Cosmed Microquark-PC Based Spirometer, Rome, Italy) according to the criteria of the European Respiratory Society (ERS) and the American Thoracic Society (ATS).
Measured: 8 weeks
Respiratory muscle strength
Respiratory muscle strength will be assessed with a portable, electronic oral pressure measuring device (Cosmed Pony Fx, Milan, Italy). Respiratory muscle strength will be determined by measuring maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP). Percentage of expected reference values according to gender and age will be used for the MIP value. The clinical significance for this patient group is 17.2 cmH2O for the measured MIP value.
Measured: 8 weeks
COPD Assessment Questionnaire
The COPD Assessment Test (CAT) will be used to assess health status impairment in individuals with COPD. The CAT is an eight-item test consisting of questions that evaluate the severity of symptoms such as dyspnea, cough, and sputum production and the impact of the disease on daily life. It is recommended that the minimal clinical significance is a change of 2 points.
Measured: 8 weeks
Muscle activity
Muscle activity of transversus abdominis (TrA), rectus abdominis (RA), lumbar multifidus (LM) and quadriceps muscles will be evaluated. Muscle activity will be evaluated using surface electromyography (EMG) (Neuro-MEP, Ivanovo, Russia). There is no cut-off value for these parameters in this patient group. The changes will be stated numerically and as a percentage as a result of the evaluations of the patients before and after the exercise training.
Measured: 8 weeks
Muscle Thickness
Muscle thickness of transversus abdominis (TrA), rectus abdominis (RA), lumbar multifidus (LM) and quadriceps muscles will be evaluated. Muscle thickness will be evaluated using ultrasound (LOGIQ P9, GE Healthcare, USA). There is no cut-off value for these parameters in this patient group. The changes will be stated numerically and as a percentage as a result of the evaluations of the patients before and after the exercise training.
Measured: 8 weeks
Timed up and go test
The Timed Up and Go Test (TUG) will be used for the balance assessment of individuals participating in the study. TUG is a frequently used, easily applicable, valid and reliable, performance-based functional mobility and balance test that evaluates dynamic balance in the clinic. It has been shown that dynamic balance impairment in COPD is associated with inadequate oxygenation and peripheral muscle weakness. Individuals who complete the test in 12 seconds or more have a risk of falling. This test, which has different cut-off values according to some disease groups, has a value of 13.5 seconds for general adults.
Measured: 8 weeks
Functional reach test
Functional reach test will be used for the balance assessment of individuals participating in the study. Individuals who can reach 25 cm and more have a low risk of falling. Individuals who can reach between 15-25 cm have a 2 times higher risk of falling than normal. Individuals who can reach 15 cm and below have a 4 times higher risk of falling than normal. Individuals who cannot reach at all have an 8 times higher risk of falling than normal.
Measured: 8 weeks
St George Health Questionnaire
St. George's Respiratory Questionnaire (SGRQ), a seventy-six-item health-related quality of life assessment questionnaire, will be used to assess the quality of life of the subjects.The result values are between 0 and 100 and the higher the value, the greater the degree to which the patient's quality of life is affected by the disease. Minimal significant variability in the treatment response follow-up was stated as a 4 point change.
Measured: 8 weeks
Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression (HAD) scale will be used to determine the anxiety and depression levels of individuals participating in the study. This scale is a self-report scale that includes anxiety and depression subscales and consists of 14 items, seven of which investigate depression and seven of which investigate anxiety levels.The cut-off point for the anxiety subscale of the HAD Turkish form was found to be 10 and the cut-off point for the depression subscale was found to be 7. Patients who score above these points can be considered as a risk group. Anxiety and depression score 07: normal, 8-11: borderline, >11: anxiety and depression
Measured: 8 weeks
Six Minute Walk Test (6MWT)
6MWT will be used to evaluate the exercise capacities of individuals who will participate in the study. The individuals' walking distance and cardiac parameters during the test will be recorded.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start1 Oct 2024
- Primary completion18 Jul 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Cansu Özkılıçaslan, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680960
- Sponsor's protocol ID
- AEŞH-BADEK-2024-553-
- Status last verified
- Nov 2024
- First submitted
- 3 Nov 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Different Exercise Approaches on Exercise Capacity, Muscle Parameters and Quality of Life in Chronic Obstructive Pulmonary Disease Patients
- ClinicalTrials.gov ID
- NCT06680960
- Acronym / sponsor ID
- AEŞH-BADEK-2024-553-
- Keywords
- copd, exercise training, trunk stabilisation, muscle parameters
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 18 Jul 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 8 Nov 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.
The beneficial effects of exercise training in individuals with chronic obstructive pulmonary disease (COPD) are well known. Standard exercise training includes structured aerobic exercise training and resistance exercise training programs applied to upper and lower extremity muscle groups. No study has been found in the literature that includes a trunk stabilization training program that includes muscles that provide whole body stabilization in COPD patients.
Detailed description
The investigators aimed to determine the effects of an aerobic exercise training program, resistance exercise training, and an additional trunk stabilization training program in individuals with COPD.
Individuals diagnosed with COPD between the ages of 40-80 who applied to Ankara Etlik City Hospital Chest Diseases Polyclinic will be included in the study. Data collection tools and exercise training programs will be made by the same researchers. A total of 44 COPD patients, 22 in each group, will be included in the study.
COPD individuals who agree to participate in the study will be randomised electronically using a randomisation program and participants will be divided into two groups.
Group 1: Aerobic exercise training and resistance exercise training and trunk stabilisation strength training Group 2: Aerobic exercise training, resistance exercise training and respiratory exercise training
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trunk Stabilisation Exercise Group | Active comparator | Other: Trunk stabilisation exercises |
| Respiratory Exercise Group | Active comparator | Other: Respiratory exercises |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Having a diagnosis of COPD
- Being between the ages of 40-80
- Being clinically stable (not having had an exacerbation in the last month)
- Being able to cooperate with the tests
- Not participating in any exercise training studies
Key exclusion criteria (8 listed)
- Having other lung or lung involvement diseases other than COPD
- Having uncontrolled hypertension, arrhythmia and a history of myocardial infarction in the last month, unstable angina, advanced heart failure and other cardiac instability conditions
- Being hemodynamically unstable
- Being on noninvasive mechanical ventilation (NIMV) and long-term oxygen therapy (LTOT)
- Having a history of neuromuscular disease, scoliosis, chest wall surgery
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 |
|---|---|---|
| Trunk stabilisation exercisesThis exercise program includes aerobic exercise, resistance exercise and trunk stabilisation training for eight weeks. | Other | Trunk Stabilisation Exercise Group |
| Respiratory exercisesThis exercise program includes aerobic exercise, resistance exercise and respiratory exercise training for eight weeks. | Other | Respiratory Exercise Group |
Primary outcome
Maximal exercise capacity
Time frame: 8 weeks
Maximal exercise capacity will be assessed by cardiopulmonary exercise testing (CPET) using a workload protocol of increasing intensity. Monitoring will be provided with 12-lead electrocardiography at rest, during testing and recovery. During CPET, data will be recorded with the "breathe-by-breathe" method through a face mask and a gas analyzer.
11 secondary outcomes
Forced expiratory volume (FEV1)
Time frame: 8 weeks
Forced Vital Capacity (FVC)
Time frame: 8 weeks
Respiratory muscle strength
Time frame: 8 weeks
COPD Assessment Questionnaire
Time frame: 8 weeks
Muscle activity
Time frame: 8 weeks
Muscle Thickness
Time frame: 8 weeks
Timed up and go test
Time frame: 8 weeks
Functional reach test
Time frame: 8 weeks
St George Health Questionnaire
Time frame: 8 weeks
Hospital Anxiety and Depression Scale
Time frame: 8 weeks
Six Minute Walk Test (6MWT)
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
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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 Trunk stabilisation exercises and Respiratory exercises in people with COPD (Chronic Obstructive Pulmonary Disease), run by Hacettepe 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 6 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 8 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Maximal exercise capacity (time frame: 8 weeks). 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 8 Nov 2024.