The Effect of Exercise Training on lncRNA Expression in Asthma

NCT06776315 | Completed

• 2 other identifiers: Asthma_Rehab_lncRNA2024/034
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Asthma; Pulmonary Rehabilitation; Exercise; Rehabilitation; long noncoding RNA

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  Baseline and 12 weeks

Secondary Outcomes (6)

• Asthma Control Test (ACT-ACQ)

  Baseline and 12 weeks

• Asthma Quality of Life Scale (AQLQ)

  Baseline and 12 weeks

• Modified Medical Research Council (mMRC) Dyspnea Scale

  Baseline and 12 weeks

• International Physical Activity Questionnaire-Short form (IPAQ-SF)

  Baseline and 12 weeks

• Digital muscle strength measurement

  Baseline and 12 weeks

Study Arms (3)

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.

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.

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.

Genetic: No intervention

Interventions

Resistive threshold inspiratory muscle training device 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.

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

Standard pulmonary rehabilitation programme 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 (PGr)

No intervention GENETIC

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

Control Group (KGr)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

University of Health Sciences

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity; Asthma

Condition Hierarchy (Ancestors)

Behavior; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Esra PEHLİVAN, Assoc. Prof.

  Saglik Bilimleri Universitesi

  STUDY CHAIR

• Erdoğan ÇETİNKAYA, Prof. Dr.

  Yedikule Chest Diseases And Thoracic Surgery Training And Research Hospital

  STUDY DIRECTOR

• Fulya Senem KARAAHMETOGLU, PhD (c)

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: January 15, 2025
• Study Start: July 13, 2023
• Primary Completion: December 1, 2024
• Study Completion: July 30, 2025
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)