Axial Spondyloarthritis (AxSpA)NCT06699238
Effect of Aerobic Exercises on Axial Spondyloarthropathy
A study testing Home Exercise and Aerobic exercise in people with Axial Spondyloarthritis (AxSpA) and Aerobic Exercise, run by Yeşim Ozge Gunduz Gul at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to examine whether aerobic exercises, in addition to home exercises, have anti-inflammatory effects, which are evaluated by disease activity, acute phase reactants, and cytokine levels in axial spondyloarthropathy Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Axial Spondyloarthritis (AxSpA), Aerobic Exercise, Disease Activity
- What is being tested?
- Home Exercise and Aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2021to 21 Jul 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AxSpA diagnosis according to the ASAS classification criteria
- Voluntary participation in the study
- Age 20-65 ages
- Regular use of disease-modifying anti-rheumatic drugs at a stable dosage for at least 3 months
- Regular use of NSAID at a stable dosage for at least 4 weeks
- Presence of low disease activity (1.3 ≤ ASDAS-CRP< 2.1)
- Having a phone number that can be used to communicate with oneself or a family member
- At least a primary school graduate.
Who cannot join
- Presence of active peripheral joint involvement
- Having used a biological agent at any time before
- Exercising regularly for the previous 6 months
- The presence of cardiovascular, orthopedic, and neurological problems that may prevent exercise (unstable angina, uncontrolled sinus tachycardia, presence of severe aortic stenosis, uncontrolled atrial or ventricular arrhythmia, 3rd degree atrioventricular block, fracture, prosthesis, neuropathy, myopathy)
- Any other respiratory or neuromuscular disease that affects the respiratory muscles
- Presence of malignancy
Show all 17Show fewer
- Presence of pregnancy
- Having undergone any surgery in the previous 6 months,
- Presence of severe psychiatric illness
- Findings related to infection during interrogation
- Having an infection in the last 3 months
- Communication problems
- Having known diabetes mellitus
- The presence of severe comorbidity that may affect the kidneys and livers
- Inability to participate in at least 75% of the exercises
- Having left study voluntarily
- Presence of any new symptoms or findings that develop during exercise or evaluations, and may interfere with exercise.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital Physical Medicine and Rehabilitation Hospital
Ankara, 06170
About this study
Official title: Is There an Anti-inflammatory Effect of Aerobic Exercises on Axial Spondyloarthropathy Patients?: Prospective Randomised Controlled Trial
This study aimed to examine whether aerobic exercises, in addition to home exercises, have anti-inflammatory effects, which are evaluated by disease activity, acute phase reactants, and cytokine levels in axial spondyloarthropathy
Read the detailed description
Spondyloarthropathies (SpAs) are a group of chronic, inflammatory, and multisystemic diseases with common genetic, epidemiological, and clinical features. These diseases primarily involve the axial skeleton.
The pathogenesis of SpA is multiple factors. The disease-specific inflammatory response, with the contribution of environmental factors based on genetic predisposition, is responsible for the pathogenesis of the disease.1 The main cytokines thought to be involved in the pathogenesis of axSpa are tumor necrosis factor-alpha (TNF-α), interleukin-17 (IL-17), IL-23, IL-22, IL-6, IL-7, interferon-gamma (IFN-γ), IL-12, and IL-26.
There is no definitive marker associated with disease activity. Studies on cytokine levels and disease activity have shown that TNF-α, IL-6, IL-17, IL-23, and IFN-γ levels may be associated with disease activity in AS patients.4-9 Nonpharmacological and pharmacological methods are used together for the treatment of SpA. Non-pharmacological methods include patient education, smoking cessation, regular exercise, and physiotherapy practices.
Aims of exercise therapy are to improve or preserve range of motion, flexibility, balance and to improve muscle strength and aerobic capacity. Posture, stretching, breathing, strengthening, and aerobic exercises are the most recommended in treating AS.
Exercise therapy is described as the cornerstone treatment of axSpA by the European Alliance of Associations for Rheumatology (EULAR). Although patient compliance with exercise therapy is not easy, the advantages of exercise are that it is cheap, low-risk, and easy to apply compared to pharmacological treatments.
The anti-inflammatory effects of exercise have recently been discussed. Few studies have investigated the anti-inflammatory effects of exercise in patients with AS. While some of these studies showed significant improvement in disease activity, functional status, flexibility, and CRP with aerobic exercise in patients with AS, some did not. Although a few studies have shown a significant decrease in TNF-α levels in AS patients with non-aerobic exercise programs, no study has examined the changes in TNF-α and IL-17 levels with aerobic exercise treatment.
The primary aim of our study was to examine whether aerobic exercise, in addition to the home exercise program, has an anti-inflammatory effect in patients with axSpA, as evaluated by disease activity, acute phase reactants, and cytokine levels. Our secondary aim was to determine whether aerobic exercise, in addition to home exercise, has a positive effect on functional status, functional exercise capacity, quality of life, NSAID consumption, chest expansion, and spinal mobility.
- Being tested
- Home Exercise, Aerobic exercise
- Keywords
- axial spondyloarthritis, aerobic exercises, cytokines, acute phase biomarkers, non pharmacological intervention
- Medical subject headings
- Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home ExerciseOther
Also called Conventional Exercise
Standard conventional exercise for 12 weeks, 3 days a week, once a day for 30 min, including cervical, thoracic, and lumbar spine flexibility, shoulder muscles, hip flexors, hamstring and quadriceps muscle stretching, spinal flexor stretching, and extensor strengthening and breathing exercises program was shown by the same physician. Patient compliance with the exercise program was monitored weekly using telemedicine.
Aerobic exerciseOther
The aerobic exercise group performed the following training: warm-up for 5 min, walking for 20 min at an intensity that would use 60-70% of the HR reserve, and cool down for 5 min. Additionally, they performed standard conventional exercises at home for 12 weeks, 3 days a week, once a day for 30 min, including cervical, thoracic, and lumbar spine flexibility, shoulder muscles, hip flexors, hamstring and quadriceps muscle stretching, spinal flexor stretching, and extensor strengthening and breathing exercises program was shown by the same physician. Patient compliance with the exercise program was monitored weekly using telemedicine.The aerobic exercise group performed on a treadmill under the supervision of a physician.
| Study group | Role | What they receive |
|---|---|---|
| Home Exercise Group | Active comparator | The home exercise group performed only standard conventional exercises for 12 weeks, 3 days a week, once a day for 30 min, including cervical, thoracic, and lumbar spine flexibility, shoulder muscles, hip flexors, hamstring and quadriceps muscle stretching, spinal flexor stretching, and extensor strengthening and breathing exercises program was shown by the same physician. Patient compliance with the exercise program was monitored weekly using telemedicine. Receives: Other: Home Exercise |
| Aerobic Exercise Group | Experimental | The aerobic exercise group performed the following training: warm-up for 5 min, walking for 20 min at an intensity that would use 60-70% of the HR reserve, and cool down for 5 min. Additionally, they performed standard conventional exercises at home for 12 weeks, 3 days a week, once a day for 30 min, including cervical, thoracic, and lumbar spine flexibility, shoulder muscles, hip flexors, hamstring and quadriceps muscle stretching, spinal flexor stretching, and extensor strengthening and breathing exercises program was shown by the same physician. The aerobic exercise group performed on a treadmill under the supervision of a physician. Receives: Other: Home Exercise; Other: Aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
ASDAS-CRP
The Ankylosing Spondylitis Disease Activity Score (ASDAS) is an index to assess disease activity in Ankylosing Spondylitis (AS).
The prefered score uses CRP.
ASDAS-CRP = 0.12 x Back Pain + 0.06 x Duration of Morning Stiffness + 0.11 x Patient Global + 0.07 x Peripheral Pain/Swelling + 0.58 x Ln(CRP+1)
Back pain, patient global assessment, duration of morning stiffness and peripheral pain/swelling are all assessed on a numerical rating scale (from 0 to 10).
The 3 cut-offs selected to separate these states were: <1.3 between "inactive disease" and "moderate disease activity", <2.1 between "moderate disease activity" and "high disease activity", and >3.5 between "high disease activity" and "very high disease activity".
Cut-offs for improvement scores were: a change ≥1.1 units for "clinically important improvement"
Measured: 12 weeks
Tumor necrosis factor-alpha (TNF-α)
TNF-α is a chemical messenger produced by the immune system that induces inflammation. Its relation with axial spondyloarthropathy's disease activity is uncertain but inhibition of TNF-α is one of the targets of current therapies. There were no cut-off measures for TNF-α on axial spondyloarthropathy patients.
Measured: 12 weeks
Interleukin-17 (IL-17)
IL-17 is a pro-inflammatory cystine knot cytokines. They are produced by a group of T helper cell known as T helper 17 cell in response to their stimulation with IL-23. Its relation with axial spondyloarthropathy's disease activity is uncertain but inhibition of IL-17 is one of the targets of current therapies. There were no cut-off measures for IL-17 on axial spondyloarthropathy patients.
Measured: 12 weeks
C-reactive protein (CRP)
CRP is an annular (ring-shaped) pentameric protein found in blood plasma, whose circulating concentrations rise in response to inflammation. It is an acute-phase protein of hepatic origin that increases following interleukin-6 secretion by macrophages and T cells. On axial spondyloarthropathy patients it may be elevated but in some patients there could be no elevation of CRP. Also it is necessary for ASDAS-CRP calculation.
Measured: 12 weeks
Erythrocyte Sedimentation Rate (ESR)
Erythrocyte Sedimentation Rate (ESR) is the rate at which red blood cells in anticoagulated whole blood descend in a standardized tube over a period of one hour. On axial spondyloarthropathy patients it may be elevated but in some patients there could be no elevation of ESR. Also it is necessary for disease activity calculation (ASDAS-ESR).
Measured: 12 weeks
Secondary outcomes (7)
Pain Visual Analogue Scale (VAS)
The visual analogue scale (VAS) is a psychometric response scale that can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. We use the 0-10 cm VAS to measure patients' pain severity. We used 0 as no pain and 10 as unbearable pain.
Measured: 12 weeks
The Bath Ankylosing Spondylitis Functional Index (BASFI)
The Bath Ankylosing Spondylitis Functional Index was named for the location of the institution (Bath, England) where authors A. Calin and co-workers developed this validated index to determine the degree of functional limitation in patients with the inflammatory autoimmune disease Ankylosing Spondylitis (AS). we used BASFI for the patients' functional assessment. BASFI measured by answering a questionaire which has 10 questions about activities of daily life, bending, lie down, position changes, climbing stairs, standing abilities. Then gathered points divided by 10. High scores represents low functional state.
Measured: 12 weeks
Bath Ankylosing Spondylitis Metrology Index (BASMI)
BASMI used for all the patients who are attended to our study to assessment of the spinal mobility. BASMI has 3 point scale. BASMI is the most applicated and effective method to assessment of axial mobility. It has five different clinical measurements which are cervical rotation, tragus wall distance, lumbar flexion, trunk lateral flexion, and intermalleolar distance. High scores are associated with poor spinal mobility
Measured: 12 weeks
Chest expansion measurement
Chest expansion is based on the difference between the chest circumference measurement after a deep inspiration at the level of the 4th intercostal space and the chest circumference measurement after a forced expiration. The normal value of chest expansion may vary depending on age and gender. It is expected to be at least 5 cm in young healthy individuals.
Measured: 12 weeks
6 minute walk test (6 MWT)
6 MWT was used to evaluate the functional exercise capacity of the patients participating in the study. While doing 6 MWT, the patients is asked to go as fast as they can between the marked points on at least 30 meters of flat ground, but not to run. Standard commands are used during the test. The total walking distance is recorded for 6 minutes. An increase of 30 meters in 6 MWT is thought to indicate clinical improvement.
Measured: 12 weeks
Ankylosing Spondylitis Quality of Life (ASQoL)
The ASQoL scale was used in the evaluation of the patients participating in the study. This scale consists of 18 questions that can be answered "yes" or "no". 1 point is given for a "yes" answer and 0 point is given for a "no" answer. At the end of the test, all scores are added up. Numerically high results indicate a low quality of life.
Measured: 12 weeks
Weekly NSAID receive
Weekly NSAID receive has obtained by telemedicine both groups
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start1 Nov 2021
- Primary completion31 May 2023
- Study completion21 Jul 2023
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups, one group was provided home exercise program and one group run on the treadmill in addition to their home exercise program
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeşim Ozge Gunduz Gul
- Sponsor type
- Other government
- Collaborators
- Ankara Diskapi Training and Research Hospital
- Responsible party
- Sponsor-investigator, Yeşim Ozge Gunduz Gul, Ankara Etlik City Hospital
- Investigators
- Ajda Bal, MD, Professor, Study director, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699238
- Sponsor's protocol ID
- AnkaraEtlik-FTR-YOGG-01
- Status last verified
- Nov 2024
- First submitted
- 19 Nov 2024
- Last updated
- 21 Nov 2024
- 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 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There an Anti-inflammatory Effect of Aerobic Exercises on Axial Spondyloarthropathy Patients?: Prospective Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06699238
- Acronym / sponsor ID
- AnkaraEtlik-FTR-YOGG-01
- Keywords
- axial spondyloarthritis, aerobic exercises, cytokines, acute phase biomarkers, non pharmacological intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Yeşim Ozge Gunduz GulOther government
- Collaborators
- Ankara Diskapi Training and Research Hospital
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 21 Jul 2023 (actual)
- First posted
- 21 Nov 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 aimed to examine whether aerobic exercises, in addition to home exercises, have anti-inflammatory effects, which are evaluated by disease activity, acute phase reactants, and cytokine levels in axial spondyloarthropathy
Detailed description
Spondyloarthropathies (SpAs) are a group of chronic, inflammatory, and multisystemic diseases with common genetic, epidemiological, and clinical features. These diseases primarily involve the axial skeleton.
The pathogenesis of SpA is multiple factors. The disease-specific inflammatory response, with the contribution of environmental factors based on genetic predisposition, is responsible for the pathogenesis of the disease.1 The main cytokines thought to be involved in the pathogenesis of axSpa are tumor necrosis factor-alpha (TNF-α), interleukin-17 (IL-17), IL-23, IL-22, IL-6, IL-7, interferon-gamma (IFN-γ), IL-12, and IL-26.
There is no definitive marker associated with disease activity. Studies on cytokine levels and disease activity have shown that TNF-α, IL-6, IL-17, IL-23, and IFN-γ levels may be associated with disease activity in AS patients.4-9 Nonpharmacological and pharmacological methods are used together for the treatment of SpA. Non-pharmacological methods include patient education, smoking cessation, regular exercise, and physiotherapy practices.
Aims of exercise therapy are to improve or preserve range of motion, flexibility, balance and to improve muscle strength and aerobic capacity. Posture, stretching, breathing, strengthening, and aerobic exercises are the most recommended in treating AS.
Exercise therapy is described as the cornerstone treatment of axSpA by the European Alliance of Associations for Rheumatology (EULAR). Although patient compliance with exercise therapy is not easy, the advantages of exercise are that it is cheap, low-risk, and easy to apply compared to pharmacological treatments.
The anti-inflammatory effects of exercise have recently been discussed. Few studies have investigated the anti-inflammatory effects of exercise in patients with AS. While some of these studies showed significant improvement in disease activity, functional status, flexibility, and CRP with aerobic exercise in patients with AS, some did not. Although a few studies have shown a significant decrease in TNF-α levels in AS patients with non-aerobic exercise programs, no study has examined the changes in TNF-α and IL-17 levels with aerobic exercise treatment.
The primary aim of our study was to examine whether aerobic exercise, in addition to the home exercise program, has an anti-inflammatory effect in patients with axSpA, as evaluated by disease activity, acute phase reactants, and cytokine levels. Our secondary aim was to determine whether aerobic exercise, in addition to home exercise, has a positive effect on functional status, functional exercise capacity, quality of life, NSAID consumption, chest expansion, and spinal mobility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups, one group was provided home exercise program and one group run on the treadmill in addition to their home exercise program
| Arm | Type | Receives |
|---|---|---|
| Home Exercise Group | Active comparator | Other: Home ExerciseThe home exercise group performed only standard conventional exercises for 12 weeks, 3 days a week, once a day for 30 min, including cervical, thoracic, and lumbar spine flexibility, shoulder muscles, hip flexors, hamstring and quadriceps muscle stretching, spinal flexor stretching, and extensor strengthening and breathing exercises program was shown by the same physician. Patient compliance with the exercise program was monitored weekly using telemedicine. |
| Aerobic Exercise Group | Experimental | Other: Home Exercise, Other: Aerobic exerciseThe aerobic exercise group performed the following training: warm-up for 5 min, walking for 20 min at an intensity that would use 60-70% of the HR reserve, and cool down for 5 min. Additionally, they performed standard conventional exercises at home for 12 weeks, 3 days a week, once a day for 30 min, including cervical, thoracic, and lumbar spine flexibility, shoulder muscles, hip flexors, hamstring and quadriceps muscle stretching, spinal flexor stretching, and extensor strengthening and breathing exercises program was shown by the same physician. The aerobic exercise group performed on a treadmill under the supervision of a physician. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- AxSpA diagnosis according to the ASAS classification criteria
- Voluntary participation in the study
- Age 20-65 ages
- Regular use of disease-modifying anti-rheumatic drugs at a stable dosage for at least 3 months
- Regular use of NSAID at a stable dosage for at least 4 weeks
Key exclusion criteria (17 listed)
- Presence of active peripheral joint involvement
- Having used a biological agent at any time before
- Exercising regularly for the previous 6 months
- The presence of cardiovascular, orthopedic, and neurological problems that may prevent exercise (unstable angina, uncontrolled sinus tachycardia, presence of severe aortic stenosis, uncontrolled atrial or ventricular arrhythmia, 3rd degree atrioventricular block, fracture, prosthesis, neuropathy, myopathy)
- Any other respiratory or neuromuscular disease that affects the respiratory muscles
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 |
|---|---|---|
| Home ExerciseAlso: Conventional ExerciseStandard conventional exercise for 12 weeks, 3 days a week, once a day for 30 min, including cervical, thoracic, and lumbar spine flexibility, shoulder muscles, hip flexors, hamstring and quadriceps muscle stretching, spinal flexor stretching, and extensor strengthening and breathing exercises program was shown by the same physician. Patient compliance with the exercise program was monitored weekly using telemedicine. | Other | Aerobic Exercise Group, Home Exercise Group |
| Aerobic exerciseThe aerobic exercise group performed the following training: warm-up for 5 min, walking for 20 min at an intensity that would use 60-70% of the HR reserve, and cool down for 5 min. Additionally, they performed standard conventional exercises at home for 12 weeks, 3 days a week, once a day for 30 min, including cervical, thoracic, and lumbar spine flexibility, shoulder muscles, hip flexors, hamstring and quadriceps muscle stretching, spinal flexor stretching, and extensor strengthening and breathing exercises program was shown by the same physician. Patient compliance with the exercise program was monitored weekly using telemedicine.The aerobic exercise group performed on a treadmill under the supervision of a physician. | Other | Aerobic Exercise Group |
Primary outcome
ASDAS-CRP
Time frame: 12 weeks
The Ankylosing Spondylitis Disease Activity Score (ASDAS) is an index to assess disease activity in Ankylosing Spondylitis (AS). The prefered score uses CRP. ASDAS-CRP = 0.12 x Back Pain + 0.06 x Duration of Morning Stiffness + 0.11 x Patient Global + 0.07 x Peripheral Pain/Swelling + 0.58 x Ln(CRP+1) Back pain, patient global assessment, duration of morning stiffness and peripheral pain/swelling are all assessed on a numerical rating scale (from 0 to 10). The 3 cut-offs selected to separate these states were: <1.3 between "inactive disease" and "moderate disease activity", <2.1 between "moderate disease activity" and "high disease activity", and >3.5 between "high disease activity" and "very high disease activity". Cut-offs for improvement scores were: a change ≥1.1 units for "clinically important improvement"
Tumor necrosis factor-alpha (TNF-α)
Time frame: 12 weeks
TNF-α is a chemical messenger produced by the immune system that induces inflammation. Its relation with axial spondyloarthropathy's disease activity is uncertain but inhibition of TNF-α is one of the targets of current therapies. There were no cut-off measures for TNF-α on axial spondyloarthropathy patients.
Interleukin-17 (IL-17)
Time frame: 12 weeks
IL-17 is a pro-inflammatory cystine knot cytokines. They are produced by a group of T helper cell known as T helper 17 cell in response to their stimulation with IL-23. Its relation with axial spondyloarthropathy's disease activity is uncertain but inhibition of IL-17 is one of the targets of current therapies. There were no cut-off measures for IL-17 on axial spondyloarthropathy patients.
C-reactive protein (CRP)
Time frame: 12 weeks
CRP is an annular (ring-shaped) pentameric protein found in blood plasma, whose circulating concentrations rise in response to inflammation. It is an acute-phase protein of hepatic origin that increases following interleukin-6 secretion by macrophages and T cells. On axial spondyloarthropathy patients it may be elevated but in some patients there could be no elevation of CRP. Also it is necessary for ASDAS-CRP calculation.
Erythrocyte Sedimentation Rate (ESR)
Time frame: 12 weeks
Erythrocyte Sedimentation Rate (ESR) is the rate at which red blood cells in anticoagulated whole blood descend in a standardized tube over a period of one hour. On axial spondyloarthropathy patients it may be elevated but in some patients there could be no elevation of ESR. Also it is necessary for disease activity calculation (ASDAS-ESR).
7 secondary outcomes
Pain Visual Analogue Scale (VAS)
Time frame: 12 weeks
The Bath Ankylosing Spondylitis Functional Index (BASFI)
Time frame: 12 weeks
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Time frame: 12 weeks
Chest expansion measurement
Time frame: 12 weeks
6 minute walk test (6 MWT)
Time frame: 12 weeks
Ankylosing Spondylitis Quality of Life (ASQoL)
Time frame: 12 weeks
Weekly NSAID receive
Time frame: 12 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 21 Nov 2024.
- 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.
Ajda Bal, MD, Professor study director
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Exercise and Aerobic exercise in people with Axial Spondyloarthritis (AxSpA) and Aerobic Exercise, run by Yeşim Ozge Gunduz Gul 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 8 inclusion and 17 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 21 Nov 2024. 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?
ASDAS-CRP (time frame: 12 weeks). The study lists 5 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 21 Nov 2024.