RehabilitationNCT06776315
The Effect of Exercise Training on lncRNA Expression in Asthma
A study testing Resistive threshold inspiratory muscle training device and Standard pulmonary rehabilitation programme in people with Rehabilitation and Pulmonary Rehabilitation, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to examine the effects of traditional respiratory rehabilitation and respiratory muscle strengthening training added to this program at the genetic level in asthma. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Rehabilitation, Pulmonary Rehabilitation, Long Noncoding RNA
- What is being tested?
- Resistive threshold inspiratory muscle training device and Standard pulmonary rehabilitation programme
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Jul 2023to 30 Jul 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being between the ages of 18 and 75,
- Being diagnosed with severe persistent asthma by a chest physician in accordance with the Global Initiative for Asthma (GINA) guideline criteria,
- Patients with type 2 inflammation markers. According to the accepted standard; Peripheral eosinophils ≥150/µL and/or induced sputum eosinophils ≥2% - Airway hyperresponsiveness (PC20 methacholine < 8 mg/mL) and/or bronchodilator response (>12% or 200 mL improvement in % predicted FEV1 following 400 mg salbutamol inhalation)
Who cannot join
- Having had a recent (within the last month) respiratory tract infection,
- Having a smoking history of over 10 packs/years or having a smoking history within 6 months of quitting smoking,
- Having received oral corticosteroid treatment within the last 4 weeks,
- Having a Body Mass Index >30,
- Eosinophilic Granulomatosis with Polyangiitis (EGPA) and Allergic Bronchopulmonary Aspergillosis (ABPA),
- Vasculitis,
Show all 9Show fewer
- History of malignancy,
- Pregnancy,
- Presence of a musculoskeletal, neurological or cardiac disease that would prevent exercise.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining the Effect of Exercise Training on LncRNA MALAT1 Expression in Asthma Patients
The goal of this observational study is to examine the effects of traditional respiratory rehabilitation and respiratory muscle strengthening training added to this program at the genetic level in asthma. The main questions it aims to answer are:
- Does respiratory muscle strengthening exercise added to respiratory rehabilitation in asthmatic patients have additional benefits on rehabilitation outcome measures such as exercise capacity, shortness of breath, and muscle strength?
- Does the gain obtained with respiratory muscle strengthening in asthmatic patients increase the quality of life of patients and have a positive effect on their psychological state?
- Does respiratory rehabilitation applied to asthmatic patients have an effect on genetic changes?
- Does respiratory muscle strengthening training applied in addition to respiratory rehabilitation in asthmatic patients have an effect on genetic changes?
- Participants will be included in two different respiratory rehabilitation programs with and without respiratory muscle training, and pre- and post-treatment rehabilitation criteria and genetic changes will be compared.
Read the detailed description
Asthma is the most common chronic respiratory disease worldwide, characterized by inflammation in the respiratory tract accompanied by bronchoconstriction, edema, and increased mucosa. Oxidative stress causes smooth muscle contraction, proliferation, and hypersensitivity of the airways, while hypoxia and systemic inflammation weaken the respiratory muscles. Lung hyperinflation in asthmatic patients causes an increase in the work of breathing. The increased workload on the respiratory muscles increases the respiratory frequency and causes dyspnea.
Pharmacological agents, allergen avoidance, lifestyle modification, anti-IgE antibodies and selectively alternative/complementary drugs or non-pharmacological methods (including breathing exercises, pulmonary rehabilitation, yoga and inspiratory muscle training) are applied in the treatment of asthma. Exercise training; it has been reported to improve asthma symptoms, quality of life, exercise capacity, bronchial hyperresponsiveness, exercise-induced bronchoconstriction and cardiopulmonary fitness and reduce airway inflammation and nighttime symptoms in asthmatic patients. In addition, asthma control can be increased with appropriate timing and intensity of exercise-based PR. The physiological effect of inspiratory muscle training is to weaken the metaboreflex mechanism, possibly reducing the activity of chemosensitive afferents and sympathetic nerve stimulation. Inspiratory muscle training stimulates structural and biochemical adaptations within the inspiratory muscles. It is stated in the literature that physiotherapy approaches such as breathing exercises and respiratory muscle training provide clinical benefits by increasing inspiratory muscle strength and reducing symptoms and the need for bronchodilators.
In recent years, the role of lncRNAs has also been emphasized in studies conducted on asthma patients. LncRNAs are long non-coding RNAs and there are studies indicating that they play an important role in the regulation of asthma. However, there is no study in the literature examining the effect of exercise training on lncRNA MALAT1 in asthmatic patients. Asthma is the most common chronic respiratory disease worldwide, characterized by inflammation in the respiratory tract accompanied by bronchoconstriction, edema, and increased mucosa. Oxidative stress causes smooth muscle contraction, proliferation, and hypersensitivity of the airways, while hypoxia and systemic inflammation weaken the respiratory muscles. Lung hyperinflation in asthmatic patients causes an increase in the work of breathing. The increased workload on the respiratory muscles increases the respiratory frequency and causes dyspnea.
Pharmacological agents, allergen avoidance, lifestyle modification, anti-IgE antibodies and selectively alternative/complementary drugs or non-pharmacological methods (including breathing exercises, pulmonary rehabilitation, yoga and inspiratory muscle training) are applied in the treatment of asthma. Exercise training; it has been reported to improve asthma symptoms, quality of life, exercise capacity, bronchial hyperresponsiveness, exercise-induced bronchoconstriction and cardiopulmonary fitness and reduce airway inflammation and nighttime symptoms in asthmatic patients. In addition, asthma control can be increased with appropriate timing and intensity of exercise-based PR. The physiological effect of inspiratory muscle training is to weaken the metaboreflex mechanism, possibly reducing the activity of chemosensitive afferents and sympathetic nerve stimulation. Inspiratory muscle training stimulates structural and biochemical adaptations within the inspiratory muscles. It is stated in the literature that physiotherapy approaches such as breathing exercises and respiratory muscle training provide clinical benefits by increasing inspiratory muscle strength and reducing symptoms and the need for bronchodilators.
In recent years, the role of lncRNAs has also been emphasized in studies conducted on asthma patients. LncRNAs are long non-coding RNAs and there are studies indicating that they play an important role in the regulation of asthma. However, there is no study in the literature examining the effect of exercise training on lncRNA MALAT1 in asthmatic patients. The research is a preliminary study for further studies in this field.Asthma is the most common chronic respiratory disease worldwide, characterized by inflammation in the respiratory tract accompanied by bronchoconstriction, edema, and increased mucosa. Oxidative stress causes smooth muscle contraction, proliferation, and hypersensitivity of the airways, while hypoxia and systemic inflammation weaken the respiratory muscles. Lung hyperinflation in asthmatic patients causes an increase in the work of breathing. The increased workload on the respiratory muscles increases the respiratory frequency and causes dyspnea.
Pharmacological agents, allergen avoidance, lifestyle modification, anti-IgE antibodies and selectively alternative/complementary drugs or non-pharmacological methods (including breathing exercises, pulmonary rehabilitation, yoga and inspiratory muscle training) are applied in the treatment of asthma. Exercise training; it has been reported to improve asthma symptoms, quality of life, exercise capacity, bronchial hyperresponsiveness, exercise-induced bronchoconstriction and cardiopulmonary fitness and reduce airway inflammation and nighttime symptoms in asthmatic patients. In addition, asthma control can be increased with appropriate timing and intensity of exercise-based PR. The physiological effect of inspiratory muscle training is to weaken the metaboreflex mechanism, possibly reducing the activity of chemosensitive afferents and sympathetic nerve stimulation. Inspiratory muscle training stimulates structural and biochemical adaptations within the inspiratory muscles. It is stated in the literature that physiotherapy approaches such as breathing exercises and respiratory muscle training provide clinical benefits by increasing inspiratory muscle strength and reducing symptoms and the need for bronchodilators.
In recent years, the role of lncRNAs has also been emphasized in studies conducted on asthma patients. LncRNAs are long non-coding RNAs and there are studies indicating that they play an important role in the regulation of asthma. However, there is no study in the literature examining the effect of exercise training on lncRNA MALAT1 in asthmatic patients. The research is a preliminary study for further studies in this field.
- Conditions
- Rehabilitation, Pulmonary Rehabilitation, Long Noncoding RNA, Exercise, Asthma
- Being tested
- Resistive threshold inspiratory muscle training device, Standard pulmonary rehabilitation programme, No intervention
- Keywords
- Asthma, Pulmonary Rehabilitation, Exercise, Rehabilitation, long noncoding RNA
- Medical subject headings
- Motor Activity, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistive threshold inspiratory muscle training deviceDevice
In the other arm of the study, respiratory muscle training is performed in addition to the "standard pulmonary rehabilitation program." Respiratory muscle strengthening training is performed with a resistive thereshold inspiratory muscle strengthening device. The exercise is performed at an intensity of 30% of the maximum inspiratory pressure determined by mouth pressure measurement. The exercise is performed in 7 sets, with 2 minutes of work and 1 minute break for a total of 21 minutes.
Standard pulmonary rehabilitation programmeProcedure or surgery
Patients are asked to perform thoracic, diaphragmatic breathing, and lower basal breathing exercises with 10 repetitions. Then, strengthening exercises are performed on the major muscle groups of the upper and lower extremities. In accordance with the resistance training program in the ATS/ERS guidelines for pulmonary rehabilitation, two to four sets of 6-12 repetitions are performed with intensities ranging from 50% to 85% of one maximum repetition, two to three times a week. During the exercises, the patient is questioned about their fatigue and dyspnea levels using the Borg scale, and breaks are given when necessary. The aerobic exercise program is performed as a 12-week, 3-day-a-week self-walking exercise. The walking program is performed in the form of walking on flat ground at 60% workload, based on the data obtained from the 6-minute walking test result (land-based walking).
No interventionGenetic
Peripheral blood samples will be taken once from the participants in the control group and no other intervention will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Rehabilitation Group (PGr) | Active comparator | In the PGr program, exercises are planned to be performed under the supervision of a remote physiotherapist, 2 days a week with the telerehabilitation method and 1 day as a home-based program by the patient. The exercise program includes aerobic, resistance exercises and respiratory exercises, and patients are followed for 3 months. Receives: Procedure: Standard pulmonary rehabilitation programme |
| Pulmonary Rehabilitation Group with Inspiratory Muscle Training (IKE+PGr) | Experimental | In the PGr program, exercises are planned under the supervision of a remote physiotherapist, with the telerehabilitation method 2 days a week and with a program to be done by the patient at home 1 day a week. The exercise program includes aerobics, resistance exercises, respiratory exercises and respiratory muscle strengthening training with a resistive thereshold inspiratory muscle strengthening device, and patients are followed for 3 months. Receives: Device: Resistive threshold inspiratory muscle training device |
| Control Group (KGr) | Other | The KGr group will consist of women and men aged between 18-65, who have signed the informed consent form regarding the study, have a BMI <30, are non-smokers, have no known systemic disease, and have FEV1>80, and are age and gender matched to the exercise groups. Receives: Genetic: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
lncRNA MALAT1 expression levels
Real-time PCR will be performed twice for each sample for each gene, and after all the steps, ΔCT, ΔΔCT, 2^(ΔΔCT) fold change in expression between the experiment and control.
Measured: Baseline and 12 weeks
Respiratory Muscle Strength Measurement
The patient is seated in a straight-backed chair. The patient is asked to grasp the silicone mouthpiece with his/her mouth and inhale and exhale as quickly and deeply as possible. The measurements are repeated until 3 measurement values are obtained with a maximum of 10% deviation between the measured peak value. The maximum value is taken among the measured values.
Measured: Baseline and 12 weeks
Forced Expiratory Volume in 1 s (FEV1 )
FEV1 will perform by using the Pony Fx spirometry device, and according to the American Thoracic Society (ATS) guidelines.
Measured: Baseline and 12 weeks
Exercise capacity
A 6-minute walk test is performed for exercise capacity. After resting in a chair for a sufficient period (>30 minutes), patients walk as fast as possible, without running, for 6 minutes on a straight 30-meter corridor. Before and after the test, the patient's fatigue and dyspnea are questioned using the Modified Borg Scale. Oxygen saturation and heart rate are monitored and recorded using a finger pulse oximeter before, during, and after the test.
Measured: Baseline and 12 weeks
Forced Vital Capacity (FVC)
FVC will perform by using the Pony Fx spirometry device, and according to the American Thoracic Society (ATS) guidelines.
Measured: Baseline and 12 weeks
FEV1/FEVC
FEV1/FEVC will perform by using the Pony Fx spirometry device, and according to the American Thoracic Society (ATS) guidelines.
Measured: Baseline and 12 weeks
Secondary outcomes (6)
Asthma Control Test (ACT-ACQ)
ACQ is a scale that evaluates the patient's perspective on their current asthma control level, which can be used to evaluate the general status of their asthma control. The test consists of five questions, the highest score is 25 and the lowest score is zero. A score of 25 indicates full control, while a score between 24-20 indicates partial control. A score below 19 on the scale indicates that asthma is uncontrolled.
Measured: Baseline and 12 weeks
Asthma Quality of Life Scale (AQLQ)
It is a 32-question asthma-specific quality of life scale. It evaluates the responses with a 7-point scale (1: Severe effect, 7: No effect). It consists of 12 different questions about asthma symptoms, 11 about activity limitation, 5 about emotional function and 4 about environmental factors. Total score average and average scores for sub-dimensions are calculated.
Measured: Baseline and 12 weeks
Modified Medical Research Council (mMRC) Dyspnea Scale
mMRC is a 0-4 point category scale where patients select the value that best describes their level of dyspnea. Increases in mMRC levels, especially values of 2 and above, are considered to indicate an increased risk of mortality.
Measured: Baseline and 12 weeks
International Physical Activity Questionnaire-Short form (IPAQ-SF)
It is an internationally valid questionnaire for the assessment of physical activity. The short form of the questionnaire consists of seven questions and provides information about the time spent in sitting, walking, moderate and intense activities. A score is obtained as "MET-minutes/week" by multiplying minutes, days and MET values. The numerical values obtained are classified as inactive, minimally active or very active.
Measured: Baseline and 12 weeks
Digital muscle strength measurement
Muscle strength is assessed using an electronic hand dynamometer. The patient is asked to maintain muscle strength against the dynamometer for at least 5 seconds in each attempt, with the force measurement repeated 3 times. The best value from the 3 test results is recorded.
Measured: Baseline and 12 weeks
Hospital Anxiety and Depression Scale (HADS)
It is a scale that questions whether patients have clinical symptoms of anxiety and depression. HADS-A is the anxiety subscale and consists of 7 questions, while HADS-D is the depression subscale and consists of 7 questions. Scoring is between 0-21 for both tests. An increase in the score on the scale means that the severity of anxiety and depression increases. The cut-off points were 10 for the anxiety subscale and 7 for the depression subscale.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start13 Jul 2023
- Primary completion1 Dec 2024
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fulya Senem Karaahmetoglu, Saglik Bilimleri Universitesi
- Investigators
- Esra PEHLİVAN, Assoc. Prof., Study chair, Saglik Bilimleri UniversitesiErdoğan ÇETİNKAYA, Prof. Dr., Study director, Yedikule Chest Diseases And Thoracic Surgery Training And Research HospitalFulya Senem KARAAHMETOGLU, PhD (c), Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776315
- Sponsor's protocol ID
- Asthma_Rehab_lncRNA
- Other IDs
- 2024/034
- Status last verified
- Feb 2026
- First submitted
- 13 Dec 2024
- Last updated
- 4 Feb 2026
- 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 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effect of Exercise Training on LncRNA MALAT1 Expression in Asthma Patients
- ClinicalTrials.gov ID
- NCT06776315
- Acronym / sponsor ID
- Asthma_Rehab_lncRNA
- Conditions
- Rehabilitation, Pulmonary Rehabilitation, Long Noncoding RNA, Exercise, Asthma
- Keywords
- Asthma, Pulmonary Rehabilitation, Exercise, Rehabilitation, long noncoding RNA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 13 Jul 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 15 Jan 2025 (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 goal of this observational study is to examine the effects of traditional respiratory rehabilitation and respiratory muscle strengthening training added to this program at the genetic level in asthma. The main questions it aims to answer are:
- Does respiratory muscle strengthening exercise added to respiratory rehabilitation in asthmatic patients have additional benefits on rehabilitation outcome measures such as exercise capacity, shortness of breath, and muscle strength?
- Does the gain obtained with respiratory muscle strengthening in asthmatic patients increase the quality of life of patients and have a positive effect on their psychological state?
- Does respiratory rehabilitation applied to asthmatic patients have an effect on genetic changes?
- Does respiratory muscle strengthening training applied in addition to respiratory rehabilitation in asthmatic patients have an effect on genetic changes?
- Participants will be included in two different respiratory rehabilitation programs with and without respiratory muscle training, and pre- and post-treatment rehabilitation criteria and genetic changes will be compared.
Detailed description
Asthma is the most common chronic respiratory disease worldwide, characterized by inflammation in the respiratory tract accompanied by bronchoconstriction, edema, and increased mucosa. Oxidative stress causes smooth muscle contraction, proliferation, and hypersensitivity of the airways, while hypoxia and systemic inflammation weaken the respiratory muscles. Lung hyperinflation in asthmatic patients causes an increase in the work of breathing. The increased workload on the respiratory muscles increases the respiratory frequency and causes dyspnea.
Pharmacological agents, allergen avoidance, lifestyle modification, anti-IgE antibodies and selectively alternative/complementary drugs or non-pharmacological methods (including breathing exercises, pulmonary rehabilitation, yoga and inspiratory muscle training) are applied in the treatment of asthma. Exercise training; it has been reported to improve asthma symptoms, quality of life, exercise capacity, bronchial hyperresponsiveness, exercise-induced bronchoconstriction and cardiopulmonary fitness and reduce airway inflammation and nighttime symptoms in asthmatic patients. In addition, asthma control can be increased with appropriate timing and intensity of exercise-based PR. The physiological effect of inspiratory muscle training is to weaken the metaboreflex mechanism, possibly reducing the activity of chemosensitive afferents and sympathetic nerve stimulation. Inspiratory muscle training stimulates structural and biochemical adaptations within the inspiratory muscles. It is stated in the literature that physiotherapy approaches such as breathing exercises and respiratory muscle training provide clinical benefits by increasing inspiratory muscle strength and reducing symptoms and the need for bronchodilators.
In recent years, the role of lncRNAs has also been emphasized in studies conducted on asthma patients. LncRNAs are long non-coding RNAs and there are studies indicating that they play an important role in the regulation of asthma. However, there is no study in the literature examining the effect of exercise training on lncRNA MALAT1 in asthmatic patients. Asthma is the most common chronic respiratory disease worldwide, characterized by inflammation in the respiratory tract accompanied by bronchoconstriction, edema, and increased mucosa. Oxidative stress causes smooth muscle contraction, proliferation, and hypersensitivity of the airways, while hypoxia and systemic inflammation weaken the respiratory muscles. Lung hyperinflation in asthmatic patients causes an increase in the work of breathing. The increased workload on the respiratory muscles increases the respiratory frequency and causes dyspnea.
Pharmacological agents, allergen avoidance, lifestyle modification, anti-IgE antibodies and selectively alternative/complementary drugs or non-pharmacological methods (including breathing exercises, pulmonary rehabilitation, yoga and inspiratory muscle training) are applied in the treatment of asthma. Exercise training; it has been reported to improve asthma symptoms, quality of life, exercise capacity, bronchial hyperresponsiveness, exercise-induced bronchoconstriction and cardiopulmonary fitness and reduce airway inflammation and nighttime symptoms in asthmatic patients. In addition, asthma control can be increased with appropriate timing and intensity of exercise-based PR. The physiological effect of inspiratory muscle training is to weaken the metaboreflex mechanism, possibly reducing the activity of chemosensitive afferents and sympathetic nerve stimulation. Inspiratory muscle training stimulates structural and biochemical adaptations within the inspiratory muscles. It is stated in the literature that physiotherapy approaches such as breathing exercises and respiratory muscle training provide clinical benefits by increasing inspiratory muscle strength and reducing symptoms and the need for bronchodilators.
In recent years, the role of lncRNAs has also been emphasized in studies conducted on asthma patients. LncRNAs are long non-coding RNAs and there are studies indicating that they play an important role in the regulation of asthma. However, there is no study in the literature examining the effect of exercise training on lncRNA MALAT1 in asthmatic patients. The research is a preliminary study for further studies in this field.Asthma is the most common chronic respiratory disease worldwide, characterized by inflammation in the respiratory tract accompanied by bronchoconstriction, edema, and increased mucosa. Oxidative stress causes smooth muscle contraction, proliferation, and hypersensitivity of the airways, while hypoxia and systemic inflammation weaken the respiratory muscles. Lung hyperinflation in asthmatic patients causes an increase in the work of breathing. The increased workload on the respiratory muscles increases the respiratory frequency and causes dyspnea.
Pharmacological agents, allergen avoidance, lifestyle modification, anti-IgE antibodies and selectively alternative/complementary drugs or non-pharmacological methods (including breathing exercises, pulmonary rehabilitation, yoga and inspiratory muscle training) are applied in the treatment of asthma. Exercise training; it has been reported to improve asthma symptoms, quality of life, exercise capacity, bronchial hyperresponsiveness, exercise-induced bronchoconstriction and cardiopulmonary fitness and reduce airway inflammation and nighttime symptoms in asthmatic patients. In addition, asthma control can be increased with appropriate timing and intensity of exercise-based PR. The physiological effect of inspiratory muscle training is to weaken the metaboreflex mechanism, possibly reducing the activity of chemosensitive afferents and sympathetic nerve stimulation. Inspiratory muscle training stimulates structural and biochemical adaptations within the inspiratory muscles. It is stated in the literature that physiotherapy approaches such as breathing exercises and respiratory muscle training provide clinical benefits by increasing inspiratory muscle strength and reducing symptoms and the need for bronchodilators.
In recent years, the role of lncRNAs has also been emphasized in studies conducted on asthma patients. LncRNAs are long non-coding RNAs and there are studies indicating that they play an important role in the regulation of asthma. However, there is no study in the literature examining the effect of exercise training on lncRNA MALAT1 in asthmatic patients. The research is a preliminary study for further studies in this field.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Rehabilitation Group (PGr) | Active comparator | Procedure: Standard pulmonary rehabilitation programmeIn the PGr program, exercises are planned to be performed under the supervision of a remote physiotherapist, 2 days a week with the telerehabilitation method and 1 day as a home-based program by the patient. The exercise program includes aerobic, resistance exercises and respiratory exercises, and patients are followed for 3 months. |
| Pulmonary Rehabilitation Group with Inspiratory Muscle Training (IKE+PGr) | Experimental | Device: Resistive threshold inspiratory muscle training deviceIn the PGr program, exercises are planned under the supervision of a remote physiotherapist, with the telerehabilitation method 2 days a week and with a program to be done by the patient at home 1 day a week. The exercise program includes aerobics, resistance exercises, respiratory exercises and respiratory muscle strengthening training with a resistive thereshold inspiratory muscle strengthening device, and patients are followed for 3 months. |
| Control Group (KGr) | Other | Genetic: No interventionThe KGr group will consist of women and men aged between 18-65, who have signed the informed consent form regarding the study, have a BMI <30, are non-smokers, have no known systemic disease, and have FEV1>80, and are age and gender matched to the exercise groups. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being between the ages of 18 and 75,
- Being diagnosed with severe persistent asthma by a chest physician in accordance with the Global Initiative for Asthma (GINA) guideline criteria,
- Patients with type 2 inflammation markers. According to the accepted standard; Peripheral eosinophils ≥150/µL and/or induced sputum eosinophils ≥2% - Airway hyperresponsiveness (PC20 methacholine < 8 mg/mL) and/or bronchodilator response (>12% or 200 mL improvement in % predicted FEV1 following 400 mg salbutamol inhalation)
Key exclusion criteria (9 listed)
- Having had a recent (within the last month) respiratory tract infection,
- Having a smoking history of over 10 packs/years or having a smoking history within 6 months of quitting smoking,
- Having received oral corticosteroid treatment within the last 4 weeks,
- Having a Body Mass Index >30,
- Eosinophilic Granulomatosis with Polyangiitis (EGPA) and Allergic Bronchopulmonary Aspergillosis (ABPA),
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 |
|---|---|---|
| Resistive threshold inspiratory muscle training deviceIn the other arm of the study, respiratory muscle training is performed in addition to the "standard pulmonary rehabilitation program." Respiratory muscle strengthening training is performed with a resistive thereshold inspiratory muscle strengthening device. The exercise is performed at an intensity of 30% of the maximum inspiratory pressure determined by mouth pressure measurement. The exercise is performed in 7 sets, with 2 minutes of work and 1 minute break for a total of 21 minutes. | Device | Pulmonary Rehabilitation Group with Inspiratory Muscle Training (IKE+PGr) |
| Standard pulmonary rehabilitation programmePatients are asked to perform thoracic, diaphragmatic breathing, and lower basal breathing exercises with 10 repetitions. Then, strengthening exercises are performed on the major muscle groups of the upper and lower extremities. In accordance with the resistance training program in the ATS/ERS guidelines for pulmonary rehabilitation, two to four sets of 6-12 repetitions are performed with intensities ranging from 50% to 85% of one maximum repetition, two to three times a week. During the exercises, the patient is questioned about their fatigue and dyspnea levels using the Borg scale, and breaks are given when necessary. The aerobic exercise program is performed as a 12-week, 3-day-a-week self-walking exercise. The walking program is performed in the form of walking on flat ground at 60% workload, based on the data obtained from the 6-minute walking test result (land-based walking). | Procedure or surgery | Pulmonary Rehabilitation Group (PGr) |
| No interventionPeripheral blood samples will be taken once from the participants in the control group and no other intervention will be performed. | Genetic | Control Group (KGr) |
Primary outcome
lncRNA MALAT1 expression levels
Time frame: Baseline and 12 weeks
Real-time PCR will be performed twice for each sample for each gene, and after all the steps, ΔCT, ΔΔCT, 2^(ΔΔCT) fold change in expression between the experiment and control.
Respiratory Muscle Strength Measurement
Time frame: Baseline and 12 weeks
The patient is seated in a straight-backed chair. The patient is asked to grasp the silicone mouthpiece with his/her mouth and inhale and exhale as quickly and deeply as possible. The measurements are repeated until 3 measurement values are obtained with a maximum of 10% deviation between the measured peak value. The maximum value is taken among the measured values.
Forced Expiratory Volume in 1 s (FEV1 )
Time frame: Baseline and 12 weeks
FEV1 will perform by using the Pony Fx spirometry device, and according to the American Thoracic Society (ATS) guidelines.
Exercise capacity
Time frame: Baseline and 12 weeks
A 6-minute walk test is performed for exercise capacity. After resting in a chair for a sufficient period (>30 minutes), patients walk as fast as possible, without running, for 6 minutes on a straight 30-meter corridor. Before and after the test, the patient's fatigue and dyspnea are questioned using the Modified Borg Scale. Oxygen saturation and heart rate are monitored and recorded using a finger pulse oximeter before, during, and after the test.
Forced Vital Capacity (FVC)
Time frame: Baseline and 12 weeks
FVC will perform by using the Pony Fx spirometry device, and according to the American Thoracic Society (ATS) guidelines.
FEV1/FEVC
Time frame: Baseline and 12 weeks
FEV1/FEVC will perform by using the Pony Fx spirometry device, and according to the American Thoracic Society (ATS) guidelines.
6 secondary outcomes
Asthma Control Test (ACT-ACQ)
Time frame: Baseline and 12 weeks
Asthma Quality of Life Scale (AQLQ)
Time frame: Baseline and 12 weeks
Modified Medical Research Council (mMRC) Dyspnea Scale
Time frame: Baseline and 12 weeks
International Physical Activity Questionnaire-Short form (IPAQ-SF)
Time frame: Baseline and 12 weeks
Digital muscle strength measurement
Time frame: Baseline and 12 weeks
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline and 12 weeks
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 4 Feb 2026.
- 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.
Esra PEHLİVAN, Assoc. Prof. study chair
Saglik Bilimleri Universitesi
Erdoğan ÇETİNKAYA, Prof. Dr. study director
Yedikule Chest Diseases And Thoracic Surgery Training And Research Hospital
Fulya Senem KARAAHMETOGLU, PhD (c) principal investigator
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistive threshold inspiratory muscle training device and Standard pulmonary rehabilitation programme in people with Rehabilitation and Pulmonary Rehabilitation, run by Saglik Bilimleri Universitesi 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: finished, as of the sponsor's last update on 4 Feb 2026. 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?
lncRNA MALAT1 expression levels (time frame: Baseline and 12 weeks). The study lists 6 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 4 Feb 2026.