Effectiveness of Mobile Respiratory Training in Ankylosing Spondylitis

Effectiveness of Respiratory Muscle Training Using a Mobile Respiratory Trainer in People With Ankylosing Spondylitis

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.

Study Overview

• Status: Completed
• Conditions: Ankylosing Spondylitis; Exercise Therapy; Respiratory Distress; Breath Tests
• Intervention / Treatment: Other: Exercise 1; Other: Exercise 2

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Usak, Turkey, 64200
    • Uşak University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Exercisers with a mobile breathing apparatus; The mobile device will be given to the patient for use. The exercise programme will be taught by the physiotherapist with face-to-face training before the study. The settings of the device will be started at the beginner level in breathing and exhalation exercises.	Other: Exercise 1; Patients were planned to complete exercise sessions 5 times a week for 12 weeks, each lasting 35 minutes per day.
Active Comparator: Pursed Lip Breathing Exercisers; 'Pursed lip breathing' will be taught to the patients in this group. The programme will be taught by the physiotherapist with face-to-face training before the study. The patient will be taught to take a deep breath through the nose as much as he/she can and then to empty the air in the lungs in a controlled manner without applying any force by pursing the lips as if whistling.	Other: Exercise 2; Patients were planned to complete exercise sessions 5 times a week for 12 weeks, each lasting 35 minutes per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tidal volume	Tidal volume; This is the amount of air breathed in or out during normal breathing. This pulmonary function test will done with a spirometry.	At the end of the 12th week of exercise schedule
Vital capacity	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.	At the end of the 12th week of exercise schedule
Forced vital capacity	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.	At the end of the 12th week of exercise schedule

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Bath Ankylosing Spondylitis Functional Index	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.	At the end of the 12th week of exercise schedule

Collaborators and Investigators

• Sponsor: Uşak University
• Investigators: Principal Investigator: Ali Y KARAHAN, MD, Uşak University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2024
• Primary Completion (Actual): May 12, 2025
• Study Completion (Actual): May 22, 2025

Study Registration Dates

• First Submitted: October 18, 2024
• First Submitted That Met QC Criteria: October 19, 2024
• First Posted (Actual): October 22, 2024

Study Record Updates

• Last Update Posted (Estimated): July 8, 2025
• Last Update Submitted That Met QC Criteria: July 4, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: respiratory exercises; Lung capacity; rheumatological diseases
• Additional Relevant MeSH Terms: Axial Spondyloarthritis; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Infections; Bone Diseases, Infectious; Spinal Diseases; Spondylarthropathies; Ankylosis; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
• Other Study ID Numbers: ayk-AirPro; 119-2024/SB002 (Other Identifier: Usak University Scientific Research Projects)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Sharing personal data must comply with the data protection principles in Turkey.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No