Axial SpondyloarthritisNCT07847879
Effects of Pulmonary Rehabilitation Exercises in Patients With Axial Spondyloarthritis
A study testing Pulmonary Rehabilitation Program and Conventional Exercise Program in people with Axial Spondyloarthritis and Ankylosing Spondylitis (AS), run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective, randomized, single-blind controlled study evaluates the effects of pulmonary rehabilitation exercises in patients with axial spondyloarthritis. Participants were randomized into two groups. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Axial Spondyloarthritis, Ankylosing Spondylitis (AS)
- What is being tested?
- Pulmonary Rehabilitation Program and Conventional Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Nov 2025to 15 Oct 2026
- Phase
- Interventional
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
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 60 years.
- Fulfillment of the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for spondyloarthritis and/or diagnosis of ankylosing spondylitis according to the Modified New York criteria.
- Willingness to participate in the study and provision of informed consent.
Who cannot join
- Presence of a respiratory or cardiovascular disease that may affect exercise capacity, including chronic obstructive pulmonary disease, asthma, cardiac arrhythmia, or heart failure.
- Recent surgery that prevents participation in the exercise program.
- Upper-extremity musculoskeletal injury or history of thoracic trauma that may interfere with the exercise program.
- Chronic neuromuscular or musculoskeletal disease limiting upper-extremity function.
- Obesity, malignancy, or epilepsy.
- Pregnancy or breastfeeding.
- Severe contractures or axial deformities, including chest deformity, advanced kyphosis greater than 40 degrees, scoliosis, or rotoscoliosis.
- Neurological or psychiatric disorders, including ongoing depression, that may interfere with participation in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sisli Hamidiye Etfal Training and Research Hospital
Istanbul, Istanbul, 34396
About this study
Official title: Effects of Pulmonary Rehabilitation Exercises on Pain, Respiratory Muscles, Quality of Life, and Disease Activity in Patients With Axial Spondyloarthritis: A Prospective Randomized Single-Blind Controlled Study
This prospective, randomized, single-blind controlled study evaluates the effects of pulmonary rehabilitation exercises in patients with axial spondyloarthritis. Participants were randomized into two groups. The intervention group received a pulmonary rehabilitation program in addition to conventional exercises, while the control group received conventional exercises alone. The primary outcome was pain intensity assessed using the Visual Analog Scale (VAS). Additional assessments included exercise capacity, pulmonary function, disease activity, quality of life, spinal mobility, and chest expansion. Outcomes were evaluated at baseline, week 8, and week 12.
Read the detailed description
This is a single-center, prospective, randomized, single-blind controlled study conducted in patients with axial spondyloarthritis followed at the Physical Medicine and Rehabilitation Clinic of Sisli Hamidiye Etfal Training and Research Hospital.
Participants were randomized into two groups using the National Cancer Institute Clinical Trial Randomization Tool with the Maximally Tolerated Imbalance method. The intervention group received conventional exercises together with a structured pulmonary rehabilitation program. The pulmonary rehabilitation program included breathing exercises, range-of-motion exercises, aerobic exercise, and strengthening exercises.
Participants in the intervention group performed home-based range-of-motion and breathing exercises twice daily for 10 repetitions. Breathing exercises included pursed-lip breathing, diaphragmatic breathing, lateral abdominal breathing, relaxation and breathing control exercises, and neck and shoulder stretching exercises. In addition, participants completed supervised cycle ergometer exercise sessions at the hospital twice weekly for 8 weeks, with each session lasting approximately 30 minutes including warm-up and cool-down periods. Aerobic exercise intensity was prescribed at moderate intensity using the Karvonen method, with the Borg Rating of Perceived Exertion used when appropriate. Upper-extremity and shoulder-girdle strengthening exercises were also included.
The control group received a conventional exercise program.
The primary outcome was pain intensity measured using the Visual Analog Scale (VAS), with the primary endpoint defined as week 12. Secondary assessments included the Six-Minute Walk Test, Ankylosing Spondylitis Quality of Life Questionnaire, Maximal Voluntary Ventilation, pulmonary function tests, chest expansion, modified Schober distance, occiput-to-wall distance, lateral spinal flexion, Bath Ankylosing Spondylitis Disease Activity Index, and C-reactive protein. Assessments were performed at baseline, week 8, and week 12.
- Being tested
- Pulmonary Rehabilitation Program, Conventional Exercise Program
- Keywords
- Pulmonary Rehabilitation,, Respiratory Function, Quality of Life, Disease Activity
- Medical subject headings
- Axial Spondyloarthritis, Spondylitis, Ankylosing, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary Rehabilitation ProgramBehavioural
The pulmonary rehabilitation program was administered for 8 weeks in addition to conventional exercise. Participants performed home-based breathing and range-of-motion exercises twice daily for 10 repetitions. Breathing exercises included pursed-lip breathing, diaphragmatic breathing, lateral abdominal breathing, relaxation and breathing control exercises, and neck and shoulder stretching. Participants also performed supervised cycle ergometer exercise twice weekly for 30 minutes per session, including warm-up and cool-down periods, together with upper-extremity and shoulder-girdle strengthening exercises.
Conventional Exercise ProgramBehavioural
Participants performed a home-based conventional exercise program. Exercise instructions were provided through a video recording, and participants attended face-to-face follow-up sessions once weekly.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Rehabilitation Plus Conventional Exercise | Experimental | Participants received a structured pulmonary rehabilitation program in addition to conventional exercise for 8 weeks. The program included home-based breathing and range-of-motion exercises, supervised cycle ergometer exercise twice weekly, and upper-extremity and shoulder-girdle strengthening exercises. Receives: Behavioral: Pulmonary Rehabilitation Program; Behavioral: Conventional Exercise Program |
| Conventional Exercise | Active comparator | Participants performed a home-based conventional exercise program. Exercise instructions were provided by video recording, and participants attended face-to-face follow-up sessions once weekly. Receives: Behavioral: Conventional Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity Assessed by Visual Analog Scale (VAS)
Pain intensity is assessed using a 0-10 cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Changes from baseline are evaluated at Week 8 and Week 12, with Week 12 defined as the primary endpoint.
Measured: Baseline, Week 8, and Week 12
Secondary outcomes (13)
Change in 6-Minute Walk Distance (6MWD)
Exercise capacity is assessed using the 6-Minute Walk Test (6MWT). The total distance walked during 6 minutes is recorded in meters. Changes from baseline are evaluated at Week 8 and Week 12. Higher walking distances indicate better functional exercise capacity.
Measured: Baseline, Week 8, and Week 12
Change in Ankylosing Spondylitis Quality of Life (ASQoL) Score
Disease-specific quality of life is assessed using the Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire. The total score ranges from 0 to 18, with higher scores indicating poorer quality of life. Changes from baseline are evaluated at Week 8 and Week 12.
Measured: Baseline, Week 8, and Week 12
Change in Maximum Voluntary Ventilation (MVV)
Respiratory muscle performance is assessed using Maximum Voluntary Ventilation (MVV), expressed in liters per minute (L/min). Changes from baseline are evaluated at Week 8 and Week 12. Higher MVV values indicate greater maximal ventilatory capacity.
Measured: Baseline, Week 8, and Week 12
Change in Forced Vital Capacity (FVC)
Forced vital capacity (FVC) is assessed by spirometry and reported both as an absolute volume in liters (L) and as a percentage of the predicted value (% predicted). Changes from baseline are evaluated at Week 8 and Week 12. Higher values generally indicate greater ventilatory capacity.
Measured: Baseline, Week 8, and Week 12
Change in Forced Expiratory Volume in One Second (FEV1)
Forced expiratory volume in one second (FEV1) is assessed by spirometry and reported both as an absolute volume in liters (L) and as a percentage of the predicted value (% predicted). Changes from baseline are evaluated at Week 8 and Week 12. Higher values generally indicate better expiratory airflow and pulmonary function.
Measured: Baseline, Week 8, and Week 12
Change in FEV1/FVC Ratio
The FEV1/FVC ratio is assessed by spirometry and expressed as a percentage (%). Changes from baseline are evaluated at Week 8 and Week 12. The ratio represents the proportion of the forced vital capacity exhaled during the first second of forced expiration.
Measured: Baseline, Week 8, and Week 12
Change in Peak Expiratory Flow (PEF)
Peak expiratory flow (PEF) is assessed by spirometry and reported in liters per second (L/s) and as a percentage of the predicted value (% predicted). Changes from baseline are evaluated at Week 8 and Week 12. Higher values indicate greater maximal expiratory flow.
Measured: Baseline, Week 8, and Week 12
Change in Chest Expansion
Chest expansion is assessed as the difference between chest circumference during maximal inspiration and maximal expiration and is expressed in centimeters (cm). Changes from baseline are evaluated at Week 8 and Week 12. Higher values indicate greater thoracic mobility.
Measured: Baseline, Week 8, and Week 12
Change in Modified Schober Test
Lumbar spine mobility is assessed using the Modified Schober Test and is expressed in centimeters (cm). Changes from baseline are evaluated at Week 8 and Week 12. Higher values indicate greater lumbar flexion mobility.
Measured: Baseline, Week 8, and Week 12
Change in Occiput-to-Wall Distance
Postural and cervical spine mobility is assessed using the occiput-to-wall distance and is expressed in centimeters (cm). Changes from baseline are evaluated at Week 8 and Week 12. Lower values indicate better postural alignment and spinal mobility.
Measured: Baseline, Week 8, and Week 12
Change in Lateral Spinal Flexion
Spinal mobility is assessed using the lateral spinal flexion test and is expressed in centimeters (cm). Changes from baseline are evaluated at Week 8 and Week 12. Higher values indicate greater lateral spinal mobility.
Measured: Baseline, Week 8, and Week 12
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score
Disease activity is assessed using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). The total score ranges from 0 to 10, with higher scores indicating greater disease activity. Changes from baseline are evaluated at Week 8 and Week 12.
Measured: Baseline, Week 8, and Week 12
Change in C-Reactive Protein (CRP) Level
Systemic inflammation is assessed by serum C-reactive protein (CRP) level, expressed in milligrams per liter (mg/L). Changes from baseline are evaluated at Week 8 and Week 12. Higher CRP levels indicate greater systemic inflammation.
Measured: Baseline, Week 8, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start10 Nov 2025
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Axial SpondyloarthritisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized into two parallel groups: pulmonary rehabilitation plus conventional exercise or conventional exercise alone.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Latif Tosun, Sisli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847879
- Sponsor's protocol ID
- AXSPA-PR-2025-01
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because no data-sharing plan was specified in the study protocol or informed consent process.