Usak University
Uşak, 64200, Turkey (Türkiye)
NCT Number: NCT06652984
Introduction and aim; Low functionality of respiratory muscles is frequently observed in various diseases such as chronic obstructive pulmonary disease, cystic fibrosis, idiopathic pulmonary fibrosis, and rheumatological diseases such as ankylosing spondylitis. Strengthening the respiratory muscles is a part of the treatment in such disease groups, and it has been reported that the quality of life of patients increases with the improvement in the respiratory muscles. Stavrou et al. In a study published in 2021, they achieved an increase in VO2max and maximum respiratory power in athletes after an exercise program with the AirOFit PRO™ (AirOFit, Copenhagen, Denmark) branded mobile breathing exercise device, which they introduced as a new technology. However, there is no study yet reporting the use of this device in rheumatological diseases.
The aim of this study is to investigate the effects of personalized breathing exercises with the AirOFit PRO™ (AirOFit, Copenhagen, Denmark) branded mobile breathing exercise device on respiratory muscles and functional exercise capacity, as well as on specific outcomes of the disease, in patients with ankylosing spondylitis.
Hypotheses of the study;
a) Hypothesis H1: Personalised breathing exercises applied with a mobile respiratory exercise device in patients with ankylosing spondylitis have a positive effect on respiratory capacity and activities of daily living in patients.
Looking for future studies?
Notify Me18 year–50 year
All sexes
Interventional
Not applicable
Uşak, 64200, Turkey (Türkiye)
Inflammation of the thoracic and costovertebral joints in ankylosing spondylitis causes gradual fusion and ossification over time, which adversely affects costal mobility and thoracic expansion. In some patients, this leads to increased dorsal kyphosis, thoracic stiffness and permanent limitation of chest wall motion. Expansion and reduced lung volume as a result of mechanical constriction caused by ankylosis of the thoracic joints explains the restrictive breathing pattern in these patients. In addition, previous studies have shown that the inflammatory process of the disease causes pain and stiffness in the thoracic joints, contributing to decreased respiratory function. It is thought that breathing exercises that strengthen the inspiratory muscles may prevent or delay complications that may occur due to inspiratory muscle weakness. Previous studies in the literature have examined the effectiveness of inspiratory muscle training in different disease groups. However, few studies in patients with ankylosing spondylitis have examined the effect of inspiratory muscle training on pulmonary function and aerobic capacity. According to our current knowledge, there is no academic study in the international literature using the mobile respiratory exercise device AirOFit PRO™ (AirOFit, Copenhagen, Denmark) for personalised respiratory exercise in any rheumatic disease.
According to our current knowledge, there is no academic study in the international literature using the AirOFit PRO™ (AirOFit, Copenhagen, Denmark) mobile respiratory exercise device for personalised respiratory exercise in any rheumatic disease. This study will be the first study to evaluate the effectiveness of a daily sustainable respiratory exercise programme suitable for home use in rheumatic patients and will be included in the international literature. In addition, it will be the basis for academic studies that enable long-term follow-up of patients with this mobile application.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients were planned to complete exercise sessions 5 times a week for 12 weeks, each lasting 35 minutes per day.
Patients were planned to complete exercise sessions 5 times a week for 12 weeks, each lasting 35 minutes per day.
Time frame: At the end of the 12th week of exercise schedule
Tidal volume; This is the amount of air breathed in or out during normal breathing. This pulmonary function test will done with a spirometry.
Time frame: At the end of the 12th week of exercise schedule
This is the total volume of air that can be breathed out after breathing in as much as you can. This pulmonary function test will done with a spirometry.
Time frame: At the end of the 12th week of exercise schedule
Forced vital capacity (FVC); This is the amount of air breathed out forcefully and quickly after breathing in as much as you can. This pulmonary function test will done with a spirometry.
Time frame: At the end of the 12th week of exercise schedule
The Bath Ankylosing Spondylitis Functional Index (BASFI) is a set of 10 questions designed to determine the degree of functional limitation in patients with Ankylosing Spondylitis (AS). The 10 questions were chosen with a major input from patients with AS. The first 8 questions are about everyday tasks and dependent on functional anatomy (bending, reaching, changing position, standing, turning, and climbing steps with or without rail) while the final 2 questions assess the patients' ability to cope with everyday life. Each item is scored on a scale of 0-10.
Uşak University
Other
Effectiveness of Respiratory Muscle Training Using a Mobile Respiratory Trainer in People With Ankylosing Spondylitis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06250062
Ankylosing Spondylitis, Ankylosis
Beijing, Beijing Municipality, China
View Trial DetailsNCT05570656
Ankylosing Spondylitis, Ankylosis
Montpellier, France
View Trial DetailsNCT05862584
Ankylosing Spondylitis, Ankylosis
Nice, France
View Trial DetailsNCT02469753
Ankylosing Spondylitis, Ankylosis
Amiens, France
View Trial Details