Ankylosing SpondylitisNCT06490796
Respiratory Training in Individuals with Ankylosing Spondylitis
A study testing Expanded diaphragm exercise and Standard diaphragm exercise in people with Ankylosing Spondylitis and Exercise Training, run by Izmir University of Economics at 1 site in Turkey (Türkiye).
Trial summary
This study was designed to investigate and compare the effects of standard diaphragmatic breathing and physiotherapy exercises versus 360-degree expandable diaphragmatic breathing and physiotherapy exercises on respiratory functions, respiratory muscle strength, clinical course of the disease (such as thoracic… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Ankylosing Spondylitis, Exercise Training, Diaphragm
- What is being tested?
- Expanded diaphragm exercise and Standard diaphragm exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Mar 2024to 30 Dec 2024
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 20-60 years
- Diagnosis according to the 1988 Modified New York criteria
- Voluntary participation
- BASDAI score of 3 or 4
- No mental problems that could hinder cooperation and understanding
Who cannot join
- Presence of a neurological disease
- Other respiratory system diseases that could affect chest expansion (COPD, asthma, etc.)
- Regular exercise within the last 3 months Additionally, individuals who miss four consecutive exercise sessions or require a change in treatment will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir University of Economics
Izmir, İzmir, 35330
About this study
Official title: Which Respiratory Training is More Effective in Individuals with Ankylosing Spondylitis: 360-Degree Expandable Diaphragm Exercises or Standard Diaphragm Exercises? a Randomized Controlled Trial
This study was designed to investigate and compare the effects of standard diaphragmatic breathing and physiotherapy exercises versus 360-degree expandable diaphragmatic breathing and physiotherapy exercises on respiratory functions, respiratory muscle strength, clinical course of the disease (such as thoracic mobility, flexibility), and functional status in individuals with Ankylosing Spondylitis (AS).
Read the detailed description
One of the primary problems in Ankylosing Spondylitis (AS) is decreased thoracic expansion. For this reason, breathing exercises, especially thorax expansion, should be included. Moreover, according to Pascal\'s principle, the pressure applied to a closed fluid must be transmitted to every part of the fluid and to the walls of the space in which it is located, without decreasing (13). For this reason, it is thought that the disrupted breathing pattern cannot be adequately corrected by standard diaphragm exercises, in which the patient\'s hand is placed on the abdomen and the anterior abdominal wall is pushed forward/outward, and the diaphragm descent to the caudal level during inspiration with 360-degree expansion of the thoraco-abdominal cavity may not be sufficient (14). The aims of this study are as follows:
- To examine and compare the effects of standard diaphragmatic breathing and physiotherapy exercises and 360-degree expanded diaphragm exercises and physiotherapy exercises on respiratory function in individuals with AS.
- To examine and compare the effects of standard diaphragmatic breathing and physiotherapy exercises, 360-degree expanded diaphragm exercises and physiotherapy exercises on inspiratory and expiratory muscle strength in individuals with AS.
- To examine and compare the effects of standard diaphragmatic breathing and physiotherapy exercises, 360-degree expanded diaphragm exercises and physiotherapy exercises on spinal mobility and the clinical course of the disease in individuals with AS.
- Conditions
- Ankylosing Spondylitis, Exercise Training, Diaphragm, Mobility
- Being tested
- Expanded diaphragm exercise, Standard diaphragm exercise
- Keywords
- Ankylosing Spondylitis, Breathing, Mobility, Functional capacity, Physiotherapy
- Medical subject headings
- Spondylitis, Ankylosing, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expanded diaphragm exerciseBehavioural
Individuals will be instructed in 360-degree expansive diaphragm exercises using the Ohmbelt device (Nilus Medical LLC, OHMBELT, Redwood City, CA, USA). Two Ohmbelt devices will be used in this study. The placement of the devices will be as described in the literature (14,23,24): The patient will be in a seated position with hips and knees flexed at 90 degrees, both feet supported on the ground, and sitting upright on a chair without back support. In this position, the Ohmbelt devices will be secured to the patient's body. Following respiratory exercises, they will be individually enrolled in the evidence-based consensus program for three-dimensional functional exercises recommended for AS patients (26,27). The exercise protocol, which includes warm-up, mobility, stretching, flexibility, and cool-down periods, will last for 20 minutes
Standard diaphragm exerciseBehavioural
Individuals in this group will be instructed in standard diaphragm exercises. They will be asked to lie on their backs with their heads and knees supported by pillows, and to close their eyes to focus before starting. Following respiratory exercises, they will be individually enrolled in the evidence-based consensus program for three-dimensional functional exercises recommended for AS patients (26,27). The exercise protocol, which includes warm-up, mobility, stretching, flexibility, and cool-down periods, will last for 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Expanded diaphragm exercise arm | Experimental | participants will use Ohmbelt device during 360-degree expansive diaphragm exercise session. Receives: Behavioral: Expanded diaphragm exercise |
| Standard diaphragm exercise arm | Active comparator | participants will attend standard breathing exercise sessions. Receives: Behavioral: Standard diaphragm exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinal movements and spinal mobility
The Bath Ankylosing Spondylitis Metrology Index (BASMI) will be used to measure clinical differences in spinal movements and spinal mobility. BASMI includes five measurements: cervical rotation, tragus-to-wall distance, lateral lumbar flexion, anterior lumbar flexion, and intermalleolar distance. A lower score on the BASMI indicates better spinal mobility (15).
Measured: From enrollment to the end of treatment at 6 weeks
Secondary outcomes (7)
Functional status
The functional status of individuals with ankylosing spondylitis will be assessed using Bath Ankylosing Spondylitis Functional Index (BASFI,0-10 cm).
Measured: From enrollment to the end of treatment at 6 weeks
Respiratory muscle strength
Respiratory muscle strength will be measured using a portable device capable of electronically measuring intraoral pressure (RP Check, MD Diagnostics Ltd., Maidstone, UK). Using the non-invasive method of intraoral pressure measurement, maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) will be recorded.
Measured: From enrollment to the end of treatment at 6 weeks
Expiratory Forced Vital Capacity (FVC)
the maximum amount of air that can forcibly be blown out after full inspiration
Measured: From enrollment to the end of treatment at 6 weeks
Forced Expiratory Volume in one second (FEV1)
FEV1 is the volume of air that can forcibly be blown out in first 1 second after full inspiration.
Measured: From enrollment to the end of treatment at 6 weeks
Forced Expiratory Flow at 25-75% of FVC (FEF25-75%)
Mean of forced expiratory flow over the middle half of the forced vital capacity.
Measured: From enrollment to the end of treatment at 6 weeks
FEV1/FVC ratio (FEV1%)
Ratio of forced expiratory volume in one second to forced vital capacity.
Measured: From enrollment to the end of treatment at 6 weeks
Disease activity
Disease activity will be assessed using Ankylosing Spondylitis Disease Activity Index' in (BASDAI) clinical diagnosis and evaluation of disease activity. This index is used to define the activity, progression, and prognosis of the disease. It is interpreted on a score ranging from 0-10. An increase in the score indicates an increase in disease activity.
Measured: From enrollment to the end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start6 Mar 2024
- Primary completion1 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir University of Economics
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Yakit Yesilyurt, Izmir University of Economics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06490796
- Sponsor's protocol ID
- B.30.2.İEÜSB.0.05.05-20-279
- Status last verified
- Jul 2024
- First submitted
- 7 Jun 2024
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Which Respiratory Training is More Effective in Individuals with Ankylosing Spondylitis: 360-Degree Expandable Diaphragm Exercises or Standard Diaphragm Exercises? a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06490796
- Acronym / sponsor ID
- B.30.2.İEÜSB.0.05.05-20-279
- Conditions
- Ankylosing Spondylitis, Exercise Training, Diaphragm, Mobility
- Keywords
- Ankylosing Spondylitis, Breathing, Mobility, Functional capacity, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Izmir University of EconomicsUniversity, hospital or other
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 8 Jul 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.
This study was designed to investigate and compare the effects of standard diaphragmatic breathing and physiotherapy exercises versus 360-degree expandable diaphragmatic breathing and physiotherapy exercises on respiratory functions, respiratory muscle strength, clinical course of the disease (such as thoracic mobility, flexibility), and functional status in individuals with Ankylosing Spondylitis (AS).
Detailed description
One of the primary problems in Ankylosing Spondylitis (AS) is decreased thoracic expansion. For this reason, breathing exercises, especially thorax expansion, should be included. Moreover, according to Pascal\'s principle, the pressure applied to a closed fluid must be transmitted to every part of the fluid and to the walls of the space in which it is located, without decreasing (13). For this reason, it is thought that the disrupted breathing pattern cannot be adequately corrected by standard diaphragm exercises, in which the patient\'s hand is placed on the abdomen and the anterior abdominal wall is pushed forward/outward, and the diaphragm descent to the caudal level during inspiration with 360-degree expansion of the thoraco-abdominal cavity may not be sufficient (14). The aims of this study are as follows:
- To examine and compare the effects of standard diaphragmatic breathing and physiotherapy exercises and 360-degree expanded diaphragm exercises and physiotherapy exercises on respiratory function in individuals with AS.
- To examine and compare the effects of standard diaphragmatic breathing and physiotherapy exercises, 360-degree expanded diaphragm exercises and physiotherapy exercises on inspiratory and expiratory muscle strength in individuals with AS.
- To examine and compare the effects of standard diaphragmatic breathing and physiotherapy exercises, 360-degree expanded diaphragm exercises and physiotherapy exercises on spinal mobility and the clinical course of the disease in individuals with AS.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Expanded diaphragm exercise arm | Experimental | Behavioral: Expanded diaphragm exerciseparticipants will use Ohmbelt device during 360-degree expansive diaphragm exercise session. |
| Standard diaphragm exercise arm | Active comparator | Behavioral: Standard diaphragm exerciseparticipants will attend standard breathing exercise sessions. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 20-60 years
- Diagnosis according to the 1988 Modified New York criteria
- Voluntary participation
- BASDAI score of 3 or 4
- No mental problems that could hinder cooperation and understanding
Key exclusion criteria (3 listed)
- Presence of a neurological disease
- Other respiratory system diseases that could affect chest expansion (COPD, asthma, etc.)
- Regular exercise within the last 3 months Additionally, individuals who miss four consecutive exercise sessions or require a change in treatment will be excluded from the study.
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 |
|---|---|---|
| Expanded diaphragm exerciseIndividuals will be instructed in 360-degree expansive diaphragm exercises using the Ohmbelt device (Nilus Medical LLC, OHMBELT, Redwood City, CA, USA). Two Ohmbelt devices will be used in this study. The placement of the devices will be as described in the literature (14,23,24): The patient will be in a seated position with hips and knees flexed at 90 degrees, both feet supported on the ground, and sitting upright on a chair without back support. In this position, the Ohmbelt devices will be secured to the patient's body. Following respiratory exercises, they will be individually enrolled in the evidence-based consensus program for three-dimensional functional exercises recommended for AS patients (26,27). The exercise protocol, which includes warm-up, mobility, stretching, flexibility, and cool-down periods, will last for 20 minutes | Behavioural | Expanded diaphragm exercise arm |
| Standard diaphragm exerciseIndividuals in this group will be instructed in standard diaphragm exercises. They will be asked to lie on their backs with their heads and knees supported by pillows, and to close their eyes to focus before starting. Following respiratory exercises, they will be individually enrolled in the evidence-based consensus program for three-dimensional functional exercises recommended for AS patients (26,27). The exercise protocol, which includes warm-up, mobility, stretching, flexibility, and cool-down periods, will last for 20 minutes. | Behavioural | Standard diaphragm exercise arm |
Primary outcome
Spinal movements and spinal mobility
Time frame: From enrollment to the end of treatment at 6 weeks
The Bath Ankylosing Spondylitis Metrology Index (BASMI) will be used to measure clinical differences in spinal movements and spinal mobility. BASMI includes five measurements: cervical rotation, tragus-to-wall distance, lateral lumbar flexion, anterior lumbar flexion, and intermalleolar distance. A lower score on the BASMI indicates better spinal mobility (15).
7 secondary outcomes
Functional status
Time frame: From enrollment to the end of treatment at 6 weeks
Respiratory muscle strength
Time frame: From enrollment to the end of treatment at 6 weeks
Expiratory Forced Vital Capacity (FVC)
Time frame: From enrollment to the end of treatment at 6 weeks
Forced Expiratory Volume in one second (FEV1)
Time frame: From enrollment to the end of treatment at 6 weeks
Forced Expiratory Flow at 25-75% of FVC (FEF25-75%)
Time frame: From enrollment to the end of treatment at 6 weeks
FEV1/FVC ratio (FEV1%)
Time frame: From enrollment to the end of treatment at 6 weeks
Disease activity
Time frame: From enrollment to the end of treatment at 6 weeks
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 12 Mar 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expanded diaphragm exercise and Standard diaphragm exercise in people with Ankylosing Spondylitis and Exercise Training, run by Izmir University of Economics 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 5 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 12 Mar 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?
Spinal movements and spinal mobility (time frame: From enrollment to the end of treatment at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2025.