Effectiveness of Mobile Respiratory Training in Ankylosing Spondylitis

NCT06652984 | Completed

• 2 other identifiers: ayk-AirPro119-2024/SB002
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankylosing Spondylitis; Respiratory Distress; Exercise Therapy; Breath Tests

Keywords

rheumatological diseases; respiratory exercises; Lung capacity

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• The Bath Ankylosing Spondylitis Functional Index

  At the end of the 12th week of exercise schedule

Study Arms (2)

Exercisers with a mobile breathing apparatus

ACTIVE COMPARATOR

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

Pursed Lip Breathing Exercisers

ACTIVE COMPARATOR

'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

Interventions

Exercise 1 OTHER

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

Exercisers with a mobile breathing apparatus

Exercise 2 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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Uşak University: lead

Study Sites (1)

Usak University

Uşak, 64200, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 34094759 RESULT

MeSH Terms

Conditions

Spondylitis, Ankylosing; Dyspnea

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ali Y KARAHAN, MD

  Uşak University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A blind physiotherapist will be in charge of the assessment of the outcomes of the study in all patients.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized pretest-posttest parallel group design

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 22, 2024
• Study Start: November 5, 2024
• Primary Completion: May 12, 2025
• Study Completion: May 22, 2025
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)