Effectiveness of Mobile Respiratory Training in Ankylosing Spondylitis

NCT ID: NCT06652984

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-05
• Study Completion Date: 2025-05-22

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.

Conditions

Ankylosing Spondylitis; Respiratory Distress; Exercise Therapy; Breath Tests

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Exercise 1

Intervention Type: OTHER

Patients were planned to complete exercise sessions 5 times a week for 12 weeks, each lasting 35 minutes per day.

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.

Group Type: ACTIVE_COMPARATOR

Exercise 2

Intervention Type: OTHER

Patients were planned to complete exercise sessions 5 times a week for 12 weeks, each lasting 35 minutes per day.

Interventions

Exercise 1

Patients were planned to complete exercise sessions 5 times a week for 12 weeks, each lasting 35 minutes per day.

Intervention Type: OTHER

Exercise 2

Patients were planned to complete exercise sessions 5 times a week for 12 weeks, each lasting 35 minutes per day.

Intervention Type: OTHER

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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uşak University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ali Y KARAHAN, MD

Role: PRINCIPAL_INVESTIGATOR

Uşak University

Locations

Usak University

Uşak, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: RESULT

PMID: 34094759 (View on PubMed)

Other Identifiers

119-2024/SB002

Identifier Type: OTHER

Identifier Source: secondary_id

ayk-AirPro

Identifier Type: -

Identifier Source: org_study_id