The Effect of Exercise Training on lncRNA Expression in Asthma

NCT ID: NCT06776315

Last Updated: 2026-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-13
• Study Completion Date: 2025-07-30

Brief 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. 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.

Conditions

Rehabilitation; Pulmonary Rehabilitation; Long Noncoding RNA; Exercise; Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pulmonary Rehabilitation Group (PGr)

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.

Group Type: ACTIVE_COMPARATOR

Standard pulmonary rehabilitation programme

Intervention Type: PROCEDURE

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).

Pulmonary Rehabilitation Group with Inspiratory Muscle Training (IKE+PGr)

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.

Group Type: EXPERIMENTAL

Resistive threshold inspiratory muscle training device

Intervention Type: DEVICE

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.

Control Group (KGr)

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.

Group Type: OTHER

No intervention

Intervention Type: GENETIC

Peripheral blood samples will be taken once from the participants in the control group and no other intervention will be performed.

Interventions

Resistive threshold inspiratory muscle training device

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.

Intervention Type: DEVICE

Standard pulmonary rehabilitation programme

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).

Intervention Type: PROCEDURE

No intervention

Peripheral blood samples will be taken once from the participants in the control group and no other intervention will be performed.

Intervention Type: GENETIC

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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,
• History of malignancy,
• Pregnancy,
• Presence of a musculoskeletal, neurological or cardiac disease that would prevent exercise.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Saglik Bilimleri Universitesi

OTHER

Sponsor Role: lead

Responsible Party

Fulya Senem Karaahmetoglu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Esra PEHLİVAN, Assoc. Prof.

Role: STUDY_CHAIR

Saglik Bilimleri Universitesi

Erdoğan ÇETİNKAYA, Prof. Dr.

Role: STUDY_DIRECTOR

Yedikule Chest Diseases And Thoracic Surgery Training And Research Hospital

Fulya Senem KARAAHMETOGLU, PhD (c)

Role: PRINCIPAL_INVESTIGATOR

Saglik Bilimleri Universitesi

Locations

University of Health Sciences

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2024/034

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Asthma_Rehab_lncRNA

Identifier Type: -

Identifier Source: org_study_id