An interventional study of Aerobic Exercise and Conventional Spinal Mobility Exercises in Axial Spondyloarthritis (AxSpA), sponsored by Bursa Yuksek Ihtisas Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to male participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Bursa Yuksek Ihtisas Training and Research Hospital · Not applicable, Interventional, and Treatment
Among 33 studies in Axial Spondyloarthritis with a site in Turkey — 7 open to participants now, 9 under way, none of them phase 3. Axial Spondyloarthritis · Turkey.
Among the 33 studies in Axial Spondyloarthritis with a site in Turkey, this one is the 18th largest by enrollment of the 20 interventional ones that give a count, is one of 7 that started in 2023, is one of 11 with no phase, and was the 33rd registered.
186 studies on the registry are indexed under Axial Spondyloarthritis; 56 are open to participants now.
Browse Axial Spondyloarthritis studies →7 of the 33 studies in Axial Spondyloarthritis with a site in Turkey are open now. Recruiting first, the newest first:
Ankara Etlik City Hospital · Sites in Turkey
Ages 18–65
Ankara University · Sites in Turkey
Ages 18–65 · Healthy volunteers
Ankara City Hospital Bilkent · Sites in Turkey
Ages 20–65
Izmir University of Economics · Sites in Turkey
Ages 18–70 · Healthy volunteers
Istanbul University - Cerrahpasa · Sites in Turkey
Ages 18–65
A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →
Of the 38 Axial Spondyloarthritis studies recruiting now, 20 (53%) set no upper age limit and 12 (32%) stop at 75 or younger; 5 take children under 18; 3 take healthy volunteers.
This study: 18 Years to 60 Years · male · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
33 studies; the count open now beside each. This study's row is marked.
First in 2014; this study’s year is marked. 7 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 42 is below the median of 108 across 122 interventional studies indexed under Axial Spondyloarthritis.
Median enrollment 115 across the 20 interventional studies, 97 across the 13 observational. Of the 23 that completed or were terminated, 6 (26%) have results posted.
This tab as a report to print or save as PDF → With an account.
9 of 33 have an industry lead sponsor. The 10 most frequent:
Bursa Yuksek Ihtisas Training and Research Hospital is the lead sponsor of 52 studies on the registry; 22 are open to participants now.
Bursa Yuksek Ihtisas Training and Research Hospital has 1 study filed under Axial Spondyloarthritis — fewer than ten, so there is no comparison to draw.
5 of the studies in Axial Spondyloarthritis with a site in Turkey that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07170384Sinem Kübra BekeMediterranean Diet and Disease Activity in Axial Spondyloarthritis Receiving Biologic Therapy | 2027-01-01 |
| NCT07133633Merck Sharp & Dohme LLCA Clinical Study of Tulisokibart (MK-7240) to Treat Radiographic Axial Spondyloarthritis (MK-7240-013) | 2027-03-29 |
| NCT07776652Istanbul University - CerrahpasaPostural Biofeedback and Exercise in Axial Spondyloarthritis | 2027-05-30 |
| NCT07855393Ankara Etlik City HospitalSurface Topography and Radiographic Spinal Damage in Radiographic Axial Spondyloarthritis | 2027-06-20 |
| NCT07833033Izmir University of EconomicsEffects of Land- and Water-Based Exercise in Axial Spondyloarthritis | 2027-10-01 |
Add all 5 to your calendar (.ics) → With an account.
Among the 33 studies in Axial Spondyloarthritis with a site in Turkey, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study investigated the effects of inspiratory muscle training (IMT) combined with aerobic exercise on diaphragm function, disease activity, functional exercise capacity, fatigue, sleep quality, and health-related quality of life in patients with axial spondyloarthritis (AxSpA).
Axial spondyloarthritis is a chronic inflammatory rheumatic disease that primarily affects the spine and sacroiliac joints. Reduced chest wall mobility and respiratory muscle function may contribute to decreased exercise capacity, fatigue, and impaired quality of life.
This randomized controlled trial was conducted at Bursa Yuksek Ihtisas Training and Research Hospital, Türkiye, between May 2023 and March 2024. Forty-two male patients aged 18-60 years were randomly allocated to two groups.
The control group received aerobic exercise and conventional spinal mobility exercises, while the intervention group received additional inspiratory muscle training using a respiratory resistance device. Both groups participated in a 12-week exercise program.
Participants were assessed at baseline and after 12 weeks using diaphragm ultrasonography, disease activity measures, functional exercise tests, and validated questionnaires assessing fatigue, sleep quality, and quality of life.
The study aimed to determine whether adding inspiratory muscle training to an aerobic exercise program provides additional clinical benefits for patients with axial spondyloarthritis.
Axial spondyloarthritis (AxSpA) is a chronic inflammatory rheumatic disease characterized by involvement of the axial skeleton, reduced spinal mobility, and functional limitations. Restricted chest wall expansion and respiratory muscle dysfunction may contribute to impaired ventilatory function, reduced exercise tolerance, fatigue, sleep disturbances, and decreased quality of life.
Although structured exercise is recommended as an important non-pharmacological intervention in AxSpA, the additional effects of inspiratory muscle training (IMT) combined with aerobic exercise on diaphragm morphology, disease activity, and patient-reported outcomes remain insufficiently investigated.
This randomized controlled trial was conducted at the Department of Physical Medicine and Rehabilitation, Bursa Yuksek Ihtisas Training and Research Hospital, Türkiye, between May 2023 and March 2024.
A total of 60 male patients with AxSpA were screened for eligibility. Forty-two eligible participants were randomly assigned to two parallel intervention groups using a lottery-based sealed-envelope randomization procedure. Thirty-five participants completed the 12-week intervention and follow-up assessments.
The first group received supervised treadmill-based aerobic exercise at 55-80% of maximum heart rate, three days per week, together with conventional spinal mobility exercises.
The second group received the same aerobic and conventional exercise program supplemented by inspiratory muscle training using a Powerbreathe respiratory resistance device. Inspiratory muscle training consisted of 30 breaths twice daily, five days per week, with progressive resistance adjustments during the intervention period.
Both groups continued their existing pharmacological treatments.
Clinical assessments were performed at baseline and after 12 weeks by an investigator blinded to group allocation.
Diaphragm morphology and function were evaluated using ultrasonographic measurements of end-inspiratory and end-expiratory diaphragm thickness and diaphragmatic thickening indices. Disease activity was assessed using the Ankylosing Spondylitis Disease Activity Score with C-reactive protein (ASDAS-CRP).
Functional exercise capacity was evaluated using the six-minute walk test. Additional assessments included the Bath Ankylosing Spondylitis Functional Index, chest expansion, Fatigue Severity Scale, Pittsburgh Sleep Quality Index, and Short Form-36 Health Survey.
The investigation was designed to evaluate the additional effects of inspiratory muscle training on respiratory, functional, and patient-reported outcomes when combined with a structured aerobic and conventional exercise program in male patients with axial spondyloarthritis.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to this group received supervised treadmill-based aerobic exercise at 55-80% of maximum heart rate, three days per week, for 12 weeks. Each session included 40 minutes of aerobic exercise, with additional warm-up and cool-down periods. Participants also performed conventional spinal mobility exercises five days per week and continued their existing pharmacological treatments.
Behavioral: Aerobic Exercise · Behavioral: Conventional Spinal Mobility Exercises
Participants assigned to this group received the same 12-week aerobic and conventional exercise program as the active comparator group, supplemented by inspiratory muscle training (IMT) using a Powerbreathe Classic HR device. IMT consisted of 30 breaths twice daily, five days per week, with progressive inspiratory resistance adjustments. Participants continued their existing pharmacological treatments throughout the study.
Behavioral: Aerobic Exercise · Behavioral: Conventional Spinal Mobility Exercises · Behavioral: Inspiratory Muscle Training
Supervised treadmill walking at 55-80% of maximum heart rate, three sessions per week for 12 weeks. Each session consisted of 40 minutes of aerobic exercise, preceded by 5-10 minutes of warm-up and followed by 5-10 minutes of cool-down.
Home-based flexibility, range-of-motion, abdominal, and breathing exercises performed as 3 sets of 10 repetitions, five days per week, for 12 weeks.
Inspiratory muscle training was performed using a Powerbreathe Classic HR inspiratory resistance device. Participants performed 30 breaths twice daily, five days per week, for 12 weeks. Training started at a resistance of 10 cmH₂O and was progressively increased according to the study protocol. Resistance adjustments were reviewed weekly by a physiatrist.
Change in Right Diaphragmatic End-Inspiratory Thickness
Right diaphragmatic end-inspiratory thickness was assessed using B-mode ultrasonography during deep inspiration. Three measurements were averaged. Thickness was recorded in centimeters, and change from baseline to Week 12 was evaluated.
Time frame: Baseline (Week 0) and Week 12
Change in Left Diaphragmatic End-Inspiratory Thickness
Left diaphragmatic end-inspiratory thickness was measured using B-mode ultrasonography during deep inspiration. Three measurements were averaged, and the change in thickness, expressed in centimeters, was evaluated from baseline to Week 12.
Time frame: Baseline (Week 0) and Week 12
Change in Ankylosing Spondylitis Disease Activity Score with C-Reactive Protein (ASDAS-CRP)
Disease activity was evaluated using ASDAS-CRP, a composite index incorporating patient-reported symptoms and serum C-reactive protein. Higher scores indicate greater disease activity. Change from baseline to Week 12 was assessed.
Time frame: Baseline (Week 0) and Week 12
Change in Six-Minute Walk Test Distance (6MWT)
Functional exercise capacity was evaluated using the six-minute walk test. The total distance walked during six minutes was recorded in meters. Change in walking distance from baseline to Week 12 was assessed.
Time frame: Baseline (Week 0) and Week 12
Change in Bath Ankylosing Spondylitis Functional Index (BASFI)
Functional limitations were evaluated using the 10-item Bath Ankylosing Spondylitis Functional Index. Total scores range from 0 to 10, with higher scores indicating greater functional impairment. Change from baseline to Week 12 was assessed.
Time frame: Baseline (Week 0) and Week 12
Change in Fatigue Severity Scale (FSS) Score
Fatigue was evaluated using the nine-item Fatigue Severity Scale. The mean item score ranges from 1 to 7, with higher scores indicating greater fatigue severity. Change from baseline to Week 12 was assessed.
Time frame: Baseline (Week 0) and Week 12
Change in Pittsburgh Sleep Quality Index (PSQI) Global Score
Sleep quality was assessed using the Pittsburgh Sleep Quality Index, with global scores ranging from 0 to 21. Higher scores indicate poorer sleep quality. Change from baseline to Week 12 was assessed.
Time frame: Baseline (Week 0) and Week 12
Change in Chest Expansion
Chest expansion was assessed using a measuring tape at the nipple line while standing. The difference between maximal inspiration and maximal expiration was measured in centimeters at baseline and Week 12.
Time frame: Baseline (Week 0) and Week 12
Change in Short Form-36 (SF-36) Health Survey Domain Scores
Health-related quality of life was assessed using the eight domains of the SF-36 Health Survey. Domain scores range from 0 to 100, with higher scores indicating better health-related quality of life. Changes from baseline to Week 12 were assessed.
Time frame: Baseline (Week 0) and Week 12
Change in Right Diaphragmatic End-Expiratory Thickness
Right diaphragmatic thickness was measured during deep expiration using B-mode ultrasonography. Three measurements were averaged. Thickness was recorded in centimeters at baseline and Week 12.
Time frame: Baseline (Week 0) and Week 12
Change in Left Diaphragmatic End-Expiratory Thickness
Left diaphragmatic thickness was measured during deep expiration using B-mode ultrasonography. Three measurements were averaged. Thickness was recorded in centimeters at baseline and Week 12.
Time frame: Baseline (Week 0) and Week 12
Plan to share: Yes — De-identified individual participant data underlying the results reported in the publication may be made available to qualified researchers upon reasonable request to the corresponding author, subject to institutional approval, applicable ethical requirements, and data protection regulations.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Following publication of the primary study results, subject to approval of individual data access requests.
Access criteria: Access requests will be evaluated by the corresponding author and the responsible institution. Data may be shared with qualified researchers for scientifically valid research purposes, subject to ethics approval where required and applicable data protection safeguards.
No publications or documents are linked to this record.
Ran from May 2023 to primary completion in Mar 2024, 10 months.
Of 45 non-industry interventional studies with no phase under Axial Spondyloarthritis, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 42. This study's 10 months is below that.
Counting every sponsor, half of 45 studies reached it within 28 months; a quarter within 11 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Bursa Yuksek Ihtisas Training and Research Hospital