Clinical trial NCT06652984: Effectiveness of Mobile Respiratory Training in Ankylosing Spondylitis
Official title: Effectiveness of Respiratory Muscle Training Using a Mobile Respiratory Trainer in People With Ankylosing Spondylitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ankylosing Spondylitis
Respiratory Distress
Exercise Therapy
Breath Tests
Keywords: rheumatological diseases
respiratory exercises
Lung capacity
Lead sponsor: Uşak University
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized pretest-posttest parallel group design
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Volunteer for the study
* Be over 18 years old
* To be in the follow-up of Usak University Rheumatology outpatient clinic
* Stability in medical treatment (keeping disease activity under control with the same medical treatment for at least 6 months)

Exclusion Criteria:

* The presence of diseases that affect the function of the respiratory system (such as pneumonia, pleurisy, empyema, pneumothorax, hemothorax, hydrothorax, atelectasis, pulmonary oedema, pulmonary hypertension, emphysema, and lung cancer).
* The presence of a regular exercise habit (regularly 3 days a week for at least six months).
* Significant physical disability or impairment (regular use of walking aids, etc.)

Primary outcomes:
measure: Tidal volume
timeFrame: At the end of the 12th week of exercise schedule
measure: Vital capacity
timeFrame: At the end of the 12th week of exercise schedule
measure: Forced vital capacity
timeFrame: At the end of the 12th week of exercise schedule
Secondary outcomes:
measure: The Bath Ankylosing Spondylitis Functional Index
timeFrame: At the end of the 12th week of exercise schedule
Other outcomes:
Locations:
city: Usak
country: Turkey
facility: Usak University
Study officials:
affiliation: Uşak University
name: Ali Y KARAHAN, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stavrou VT, Tourlakopoulos KN, Daniil Z, Gourgoulianis KI. Respiratory Muscle Strength: New Technology for Easy Assessment. Cureus. 2021 May 2;13(5):e14803. doi: 10.7759/cureus.14803.