Ankylosing SpondylitisNCT06652984
Effectiveness of Mobile Respiratory Training in Ankylosing Spondylitis
A study testing Exercise 1 and Exercise 2 in people with Ankylosing Spondylitis and Respiratory Distress, run by Uşak University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Ankylosing Spondylitis, Respiratory Distress, Exercise Therapy
- What is being tested?
- Exercise 1 and Exercise 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Nov 2024to 22 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
Hypotheses of the study;
- 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.
Read the 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.
- Being tested
- Exercise 1, Exercise 2
- Keywords
- rheumatological diseases, respiratory exercises, Lung capacity
- Medical subject headings
- Spondylitis, Ankylosing, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise 1Other
Patients were planned to complete exercise sessions 5 times a week for 12 weeks, each lasting 35 minutes per day.
Exercise 2Other
Patients were planned to complete exercise sessions 5 times a week for 12 weeks, each lasting 35 minutes per day.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Exercise 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At the end of the 12th week of exercise schedule
Secondary outcomes (1)
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.
Measured: At the end of the 12th week of exercise schedule
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start5 Nov 2024
- Primary completion12 May 2025
- Study completion22 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized pretest-posttest parallel group design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uşak University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali Y KARAHAN, MD, Principal investigator, Uşak University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652984
- Sponsor's protocol ID
- ayk-AirPro
- Other IDs
- 119-2024/SB002
- Status last verified
- Jul 2025
- First submitted
- 18 Oct 2024
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing personal data must comply with the data protection principles in Turkey.
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.
PubMed 34094759
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Respiratory Muscle Training Using a Mobile Respiratory Trainer in People With Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT06652984
- Acronym / sponsor ID
- ayk-AirPro
- Keywords
- rheumatological diseases, respiratory exercises, Lung capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Uşak UniversityUniversity, hospital or other
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- 12 May 2025 (actual)
- Study completion
- 22 May 2025 (actual)
- First posted
- 22 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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;
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized pretest-posttest parallel group design
| Arm | Type | Receives |
|---|---|---|
| Exercisers with a mobile breathing apparatus | Active comparator | Other: Exercise 1The 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. |
| Pursed Lip Breathing Exercisers | Active comparator | Other: Exercise 2'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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise 1Patients were planned to complete exercise sessions 5 times a week for 12 weeks, each lasting 35 minutes per day. | Other | Exercisers with a mobile breathing apparatus |
| Exercise 2Patients were planned to complete exercise sessions 5 times a week for 12 weeks, each lasting 35 minutes per day. | Other | Pursed Lip Breathing Exercisers |
Primary outcome
Tidal volume
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.
Vital capacity
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.
Forced vital capacity
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.
1 secondary outcome
The Bath Ankylosing Spondylitis Functional Index
Time frame: At the end of the 12th week of exercise schedule
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Results publication: PubMed 34094759Stavrou 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.
- Individual participant dataSharing planned: No. Sharing personal data must comply with the data protection principles in Turkey.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Y KARAHAN, MD principal investigator
Uşak University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise 1 and Exercise 2 in people with Ankylosing Spondylitis and Respiratory Distress, run by Uşak University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tidal volume (time frame: At the end of the 12th week of exercise schedule). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06652984, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.