Axial Spondyloarthritis (AxSpA)PuRe-axSpANCT07430189
Multimodal Pulmonary Rehabilitation in Radiographic Axial Spondyloarthritis
A study testing Multimodal Pulmonary Rehabilitation in people with Axial Spondyloarthritis (AxSpA), run by Balikesir University at 1 site in Turkey (Türkiye).
Trial summary
This prospective pilot study aims to evaluate the efficacy of a structured 8-week multimodal pulmonary rehabilitation (PR) program specifically designed for patients with radiographic axial spondyloarthritis (r-axSpA). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Axial Spondyloarthritis (AxSpA)
- What is being tested?
- Multimodal Pulmonary Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2018to 30 Sep 2020
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years.
- Diagnosis of radiographic axial spondyloarthritis (r-axSpA) confirmed according to the Modified New York Criteria.
- Clinical stability without acute flares or escalation of systemic therapy in the preceding 3 months.
- Ability to perform spirometry and ambulate safely.
Who cannot join
- Primary respiratory disorders (e.g., COPD and interstitial lung disease) acting as the primary cause of limitation.
- Significant cardiovascular contraindications to exercise.
- Pregnancy.
- Participation in a structured rehabilitation program within the last 3 months.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Balikesir University Faculty of Medicine
Balıkesir
About this study
Official title: Multimodal Pulmonary Rehabilitation in Radiographic Axial Spondyloarthritis: A Prospective Pilot Study Addressing Mechanical Restriction and Functional Capacity
This prospective pilot study aims to evaluate the efficacy of a structured 8-week multimodal pulmonary rehabilitation (PR) program specifically designed for patients with radiographic axial spondyloarthritis (r-axSpA). The study assesses the impact of a composite intervention incorporating aerobic conditioning, resistance training, flexibility protocols, and targeted diaphragmatic breathing on functional exercise capacity, dyspnea severity, and pulmonary function.
- Conditions
- Axial Spondyloarthritis (AxSpA)
- Being tested
- Multimodal Pulmonary Rehabilitation
- Keywords
- Pulmonary Rehabilitation, Exercise Tolerance, Dyspnea, Spirometry, Restrictive Lung Disease
- Medical subject headings
- Axial Spondyloarthritis, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Pulmonary RehabilitationBehavioural
An 8-week structured exercise program consisting of three sessions per week (two supervised hospital-based sessions and one structured home-based session). The intervention integrates aerobic conditioning using a treadmill and arm ergometer, resistance and mobility training targeting spinal extension, and specific respiratory muscle training including diaphragmatic and pursed-lip breathing maneuvers.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Pulmonary Rehabilitation | Experimental | Patients with radiographic axial spondyloarthritis (r-axSpA) receiving an 8-week structured multimodal pulmonary rehabilitation program. Receives: Behavioral: Multimodal Pulmonary Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6-Minute Walk Distance (6MWD)
Functional exercise capacity is measured by the total distance walked in 6 minutes, recorded in meters. Higher values indicate better functional exercise capacity (better outcome).
Measured: Baseline and Week 8
Secondary outcomes (4)
Change in Forced Vital Capacity (FVC)
Forced Vital Capacity (FVC) is measured via spirometry and expressed as a percentage of the predicted value. Higher percentages indicate better pulmonary volume and respiratory function (better outcome).
Measured: Baseline and Week 8
Change in Borg Dyspnea Scale
The Modified Borg Dyspnea Scale is used to assess exertional breathlessness. The scale ranges from a minimum of 0 (no dyspnea at all) to a maximum of 10 (maximal dyspnea). Higher scores indicate more severe breathlessness (worse outcome).
Measured: Baseline and Week 8
Change in BASFI Score
The Bath Ankylosing Spondylitis Functional Index (BASFI) assesses the degree of functional limitation in daily activities. The scale ranges from a minimum of 0 to a maximum of 10. Higher scores indicate greater functional impairment and disability (worse outcome).
Measured: Baseline and Week 8
Change in SF-36 Mental Health Score
The 36-Item Short Form Health Survey (SF-36) is a health-related quality of life questionnaire. The Mental Health domain is scored from a minimum of 0 to a maximum of 100. Higher scores indicate a more favorable mental health state and better well-being (better outcome).
Measured: Baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start30 May 2018
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Axial Spondyloarthritis (AxSpA)Studies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A prospective, single-arm, open-label pilot study to evaluate the feasibility and efficacy of multimodal pulmonary rehabilitation.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balikesir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ender Salbaş, Balikesir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430189
- Sponsor's protocol ID
- BAP-2018-076
- Other IDs
- 2019/86
- Acronym
- PuRe-axSpA
- Status last verified
- Feb 2026
- First submitted
- 18 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data and the analysis code are available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Pulmonary Rehabilitation in Radiographic Axial Spondyloarthritis: A Prospective Pilot Study Addressing Mechanical Restriction and Functional Capacity
- ClinicalTrials.gov ID
- NCT07430189
- Acronym / sponsor ID
- PuRe-axSpA / BAP-2018-076
- Conditions
- Axial Spondyloarthritis (AxSpA)
- Keywords
- Pulmonary Rehabilitation, Exercise Tolerance, Dyspnea, Spirometry, Restrictive Lung Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Balikesir UniversityUniversity, hospital or other
- Study start
- 30 May 2018 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 24 Feb 2026 (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 prospective pilot study aims to evaluate the efficacy of a structured 8-week multimodal pulmonary rehabilitation (PR) program specifically designed for patients with radiographic axial spondyloarthritis (r-axSpA). The study assesses the impact of a composite intervention incorporating aerobic conditioning, resistance training, flexibility protocols, and targeted diaphragmatic breathing on functional exercise capacity, dyspnea severity, and pulmonary function.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective, single-arm, open-label pilot study to evaluate the feasibility and efficacy of multimodal pulmonary rehabilitation.
| Arm | Type | Receives |
|---|---|---|
| Multimodal Pulmonary Rehabilitation | Experimental | Behavioral: Multimodal Pulmonary RehabilitationPatients with radiographic axial spondyloarthritis (r-axSpA) receiving an 8-week structured multimodal pulmonary rehabilitation program. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 75 years.
- Diagnosis of radiographic axial spondyloarthritis (r-axSpA) confirmed according to the Modified New York Criteria.
- Clinical stability without acute flares or escalation of systemic therapy in the preceding 3 months.
- Ability to perform spirometry and ambulate safely.
Key exclusion criteria (4 listed)
- Primary respiratory disorders (e.g., COPD and interstitial lung disease) acting as the primary cause of limitation.
- Significant cardiovascular contraindications to exercise.
- Pregnancy.
- Participation in a structured rehabilitation program within the last 3 months.
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 |
|---|---|---|
| Multimodal Pulmonary RehabilitationAn 8-week structured exercise program consisting of three sessions per week (two supervised hospital-based sessions and one structured home-based session). The intervention integrates aerobic conditioning using a treadmill and arm ergometer, resistance and mobility training targeting spinal extension, and specific respiratory muscle training including diaphragmatic and pursed-lip breathing maneuvers. | Behavioural | Multimodal Pulmonary Rehabilitation |
Primary outcome
Change in 6-Minute Walk Distance (6MWD)
Time frame: Baseline and Week 8
Functional exercise capacity is measured by the total distance walked in 6 minutes, recorded in meters. Higher values indicate better functional exercise capacity (better outcome).
4 secondary outcomes
Change in Forced Vital Capacity (FVC)
Time frame: Baseline and Week 8
Change in Borg Dyspnea Scale
Time frame: Baseline and Week 8
Change in BASFI Score
Time frame: Baseline and Week 8
Change in SF-36 Mental Health Score
Time frame: Baseline and Week 8
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 25 Feb 2026.
- Individual participant dataSharing planned: Yes. De-identified data and the analysis code are available from the corresponding author upon reasonable request.
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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 Multimodal Pulmonary Rehabilitation in people with Axial Spondyloarthritis (AxSpA), run by Balikesir 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 4 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 25 Feb 2026. 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?
Change in 6-Minute Walk Distance (6MWD) (time frame: Baseline and Week 8). 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 25 Feb 2026.