AzTrials
AzTrials

Axial Spondyloarthritis (AxSpA)NCT07914439

Inspiratory Muscle Training in Axial Spondyloarthritis

A study testing Aerobic Exercise, Conventional Spinal Mobility Exercises and Inspiratory Muscle Training in people with Axial Spondyloarthritis (AxSpA), run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 60 years, men only
Conditions the study is for
Axial Spondyloarthritis (AxSpA)
What is being tested?
Aerobic Exercise, Conventional Spinal Mobility Exercises and Inspiratory Muscle Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteTurkey (Türkiye)
Study dates
31 May 2023to 31 Mar 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 18 to 60 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Male patients aged 18-60 years.
  • Diagnosis of axial spondyloarthritis according to the 2009 Assessment of SpondyloArthritis international Society (ASAS) classification criteria.
  • Stable pharmacological treatment for at least 3 months prior to enrollment.
  • Provision of written informed consent.

Who cannot join

  • Acute infection.
  • Disease exacerbation or flare within the previous 3 months.
  • Changes in pharmacological treatment within the previous 3 months.
  • Cardiopulmonary diseases.
  • Endocrine diseases.
  • Systemic diseases, including hepatic or renal failure.
Show all 10Show fewer
  • Neuromuscular disorders.
  • Malignancy.
  • Spinal deformities.
  • Orthopedic disabilities.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • University of Health Sciences Bursa Yüksek İhtisas Training and Research Hospital

    Bursa, Bursa, 16800

Other trials in Turkey (Türkiye)

About this study

Official title: Impact of Inspiratory Muscle Training Plus Aerobic Exercise on Diaphragm Function, Disease Activity, and Sleep Quality in Axial Spondyloarthritis: A Pilot Randomized Controlled Trial

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.

Read more

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.

Read the detailed description

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.

Being tested
Aerobic Exercise, Conventional Spinal Mobility Exercises, Inspiratory Muscle Training
Keywords
Inspiratory Muscle Training, Aerobic Exercise, Diaphragm Ultrasonography, Diaphragm Thickness, Disease Activity, Sleep Quality, Functional Exercise Capacity
Medical subject headings
Axial Spondyloarthritis, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aerobic ExerciseBehavioural

    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.

  • Conventional Spinal Mobility ExercisesBehavioural

    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 TrainingBehavioural

    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.

Study groups in NCT07914439
Study groupRoleWhat they receive
Aerobic and Conventional ExerciseActive comparatorParticipants 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.
Receives: Behavioral: Aerobic Exercise; Behavioral: Conventional Spinal Mobility Exercises
Inspiratory Muscle Training Plus Aerobic and Conventional ExerciseExperimentalParticipants 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.
Receives: Behavioral: Aerobic Exercise; Behavioral: Conventional Spinal Mobility Exercises; Behavioral: Inspiratory Muscle Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline (Week 0) and Week 12

  2. 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.

    Measured: Baseline (Week 0) and Week 12

  3. 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.

    Measured: Baseline (Week 0) and Week 12

  4. 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.

    Measured: Baseline (Week 0) and Week 12

Secondary outcomes (7)
  1. 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.

    Measured: Baseline (Week 0) and Week 12

  2. 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.

    Measured: Baseline (Week 0) and Week 12

  3. 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.

    Measured: Baseline (Week 0) and Week 12

  4. 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.

    Measured: Baseline (Week 0) and Week 12

  5. 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.

    Measured: Baseline (Week 0) and Week 12

  6. 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.

    Measured: Baseline (Week 0) and Week 12

  7. 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.

    Measured: Baseline (Week 0) and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2026
  2. Study start31 May 2023
  3. Primary completion31 Mar 2024
  4. Study completion31 Mar 2024

Resources

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
Randomised
Intervention model
Parallel groups
Model description
This study used a two-arm, parallel-group randomized controlled design. Forty-two participants were allocated equally to an aerobic exercise and conventional exercise group (n=21) or an inspiratory muscle training plus aerobic and conventional exercise group (n=21). Both interventions lasted 12 weeks.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07914439
Sponsor's protocol ID
2011/KAEK-25 2023/05-21
Status last verified
Oct 2026
First submitted
28 Oct 2026
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A study testing Aerobic Exercise, Conventional Spinal Mobility Exercises and Inspiratory Muscle Training in people with Axial Spondyloarthritis (AxSpA), run by Bursa Yuksek Ihtisas Training and Research Hospital 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 10 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 3 Nov 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 Right Diaphragmatic End-Inspiratory Thickness (time frame: Baseline (Week 0) and Week 12). The study lists 4 primary outcomes in all. 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 3 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in