Axial Spondyloarthritis and Ankylosing SpondylitisNCT06138717
The Effect of Aerobic Exercises and Yoga Exercises in Axial Spondyloarthritis
A study testing yoga based exercises in people with Axial Spondyloarthritis and Ankylosing Spondylitis, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Axial Spondyloarthritis (AxSpA), mainly affecting the axial skeleton and sacroiliac joints, is a chronic, systemic, inflammatory disease that causes structural and functional disorders. Exercise has a significant role to play in managing treatments. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Axial Spondyloarthritis and Ankylosing Spondylitis
- What is being tested?
- yoga based exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Nov 2022to 15 Jan 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Axial spondyloarthritis patients according to ASAS criteria having a stable health condition, having ongoing fatigue, dyspnea, decreased stamina, difficulty in activities of daily living, anxiety, or depression complaints
Who cannot join
- Hemodynamically unstable, cardiac and pulmonary system unstable, with neurological, and psychological disorders patients
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital
Ankara
Nilüfer Kutay GÖKKAYA Prof MD, 5526000 ext. +90312, ankarasehir@saglik.gov.tr
About this study
Official title: The Effect of Aerobic Exercises and Yoga Exercises on Spinal Mobility, Functional Capacity and Disease Activity in Axial Spondyloarthritis: a Randomized Controlled Trial
Axial Spondyloarthritis (AxSpA), mainly affecting the axial skeleton and sacroiliac joints, is a chronic, systemic, inflammatory disease that causes structural and functional disorders. Exercise has a significant role to play in managing treatments. This study aimed to determine the effect of yoga-based exercises combined with aerobic exercise on spinal mobility, disease activity and aerobic capacity in AxSpA.
Read the detailed description
The study included 60 AxSpA patients according to ASAS criteria. Patients will be divided into two groups randomised. Group 1 (n=30) received only aerobic exercise, group 2 (n=30) received aerobic exercise and yoga exercises will be applied. Aerobic exercise intensity will be measured by cardiopulmonary exercise test (CPET). determined.
Aerobic exercises will be performed with a lower extremity ergometer for 30 minutes and 12 sessions. In group 2, in addition to aerobic exercises, spinal stretching, relaxation, respiration and meditation will be performed. A yoga-based exercise programme consisting of exercises will be applied for 40 minutes and 12 sessions.
Functional capacity before and after treatment, 6-min walk test (6MWT) and VO2 maximum and disease activity will be assessed by ASDAS-CRP. Clinical measurements Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI), Ankylosing Spondylitis Quality of Life (ASQL) scale will be used. Fibromyalgia symptom severity scale and widespread pain index scores will be calculated.
- Being tested
- yoga based exercises
- Keywords
- Axial spondyloarthritis, yoga, aerobic exercise
- Medical subject headings
- Axial Spondyloarthritis, Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
yoga based exercisesOther
Also called aerobic exercises
Aerobic exercises will be performed with a lower extremity ergometer for 30 minutes and 12 sessions.In group 2, in addition to aerobic exercises, spinal stretching, relaxation, respiration and meditation will be performed. A yoga-based exercise programme consisting of exercises will be applied for 40 minutes and 12 session
| Study group | Role | What they receive |
|---|---|---|
| only aerobic exercise | Active comparator | Aerobic exercises will be performed with a lower extremity ergometer for 30 minutes and 12 sessions. Receives: Other: yoga based exercises |
| combine aerobic exercise and yoga exercises | Active comparator | Aerobic exercises will be performed with a lower extremity ergometer for 30 minutes and 12 sessions.A yoga-based exercise programme consisting of exercises will be applied for 40 minutes and 12 session Receives: Other: yoga based exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2 max
VO2 max is the maximum rate of oxygen consumption attainable during physical exertion
Measured: six week
Six minute walk test
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity
Measured: six week
Secondary outcomes (1)
BASMI
The Bath Ankylosing Spondylitis Metrology Index (BASMI) is an index comprising 5 measures of spinal and hip mobility in AS
Measured: six week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start18 Nov 2022
- Primary completion15 Nov 2023 (estimated)
- Study completion15 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Axial Spondyloarthritis and Ankylosing SpondylitisStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138717
- Sponsor's protocol ID
- Refiye000000000000000000000002
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- 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 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aerobic Exercises and Yoga Exercises on Spinal Mobility, Functional Capacity and Disease Activity in Axial Spondyloarthritis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06138717
- Acronym / sponsor ID
- Refiye000000000000000000000002
- Keywords
- Axial spondyloarthritis, yoga, aerobic exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 18 Nov 2022 (actual)
- Primary completion
- 15 Nov 2023 (estimated)
- Study completion
- 15 Jan 2024 (estimated)
- First posted
- 18 Nov 2023 (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.
Axial Spondyloarthritis (AxSpA), mainly affecting the axial skeleton and sacroiliac joints, is a chronic, systemic, inflammatory disease that causes structural and functional disorders. Exercise has a significant role to play in managing treatments. This study aimed to determine the effect of yoga-based exercises combined with aerobic exercise on spinal mobility, disease activity and aerobic capacity in AxSpA.
Detailed description
The study included 60 AxSpA patients according to ASAS criteria. Patients will be divided into two groups randomised. Group 1 (n=30) received only aerobic exercise, group 2 (n=30) received aerobic exercise and yoga exercises will be applied. Aerobic exercise intensity will be measured by cardiopulmonary exercise test (CPET). determined.
Aerobic exercises will be performed with a lower extremity ergometer for 30 minutes and 12 sessions. In group 2, in addition to aerobic exercises, spinal stretching, relaxation, respiration and meditation will be performed. A yoga-based exercise programme consisting of exercises will be applied for 40 minutes and 12 sessions.
Functional capacity before and after treatment, 6-min walk test (6MWT) and VO2 maximum and disease activity will be assessed by ASDAS-CRP. Clinical measurements Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI), Ankylosing Spondylitis Quality of Life (ASQL) scale will be used. Fibromyalgia symptom severity scale and widespread pain index scores will be calculated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| only aerobic exercise | Active comparator | Other: yoga based exercisesAerobic exercises will be performed with a lower extremity ergometer for 30 minutes and 12 sessions. |
| combine aerobic exercise and yoga exercises | Active comparator | Other: yoga based exercisesAerobic exercises will be performed with a lower extremity ergometer for 30 minutes and 12 sessions.A yoga-based exercise programme consisting of exercises will be applied for 40 minutes and 12 session |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Axial spondyloarthritis patients according to ASAS criteria having a stable health condition, having ongoing fatigue, dyspnea, decreased stamina, difficulty in activities of daily living, anxiety, or depression complaints
Key exclusion criteria (1 listed)
- Hemodynamically unstable, cardiac and pulmonary system unstable, with neurological, and psychological disorders patients
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 |
|---|---|---|
| yoga based exercisesAlso: aerobic exercisesAerobic exercises will be performed with a lower extremity ergometer for 30 minutes and 12 sessions.In group 2, in addition to aerobic exercises, spinal stretching, relaxation, respiration and meditation will be performed. A yoga-based exercise programme consisting of exercises will be applied for 40 minutes and 12 session | Other | combine aerobic exercise and yoga exercises, only aerobic exercise |
Primary outcome
VO2 max
Time frame: six week
VO2 max is the maximum rate of oxygen consumption attainable during physical exertion
Six minute walk test
Time frame: six week
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity
1 secondary outcome
BASMI
Time frame: six week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- 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.
Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital
Ankara, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing yoga based exercises in people with Axial Spondyloarthritis and Ankylosing Spondylitis, run by Ankara City Hospital Bilkent 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2 max (time frame: six week). The study lists 2 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 18 Nov 2023.