Axial Spondyloarthritis (axSPA)YOKISPANCT06083090
Effects of Yoga Therapy in Rehabilitation Compared to Physiotherapy in Moderate Axial Spondyloarthritis (axSPA)
A study testing Yogatherapy and Physiotherapy in people with Axial Spondyloarthritis (axSPA), run by Assistance Publique - Hôpitaux de Paris at 5 sites in France.
Trial summary
A few studies have evaluated the effectiveness of yoga therapy in patients with axial spondyloarthritis (axSPA). On the other hand, studies conducted in other chronic rheumatisms such as low back pain, rheumatoid arthritis or other conditions such as cancer have shown that yogatherapy can have a effective action on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Axial Spondyloarthritis (axSPA)
- What is being tested?
- Yogatherapy and Physiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 5 sitesFrance
- Study dates
- 27 Aug 2024to 27 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- French-speaking patient aged 18 and over
- Patient with axial spondyloarthritis (axSPA) according to Assessment of SpondyloArthritis International Society, diagnosed by a rheumatologist
- "Moderately active" to "active" form of axSPA (basic BASDAI \> 3)
- Stable disease: No recent or foreseeable introduction in the next 6 months of drug treatments for axSPA (excluding analgesics)
- Absence of disabling stress urinary incontinence
- Geographical or organizational possibility of undergoing the study
- Patient informed and having signed the informed consent form for participation in the research
Who cannot join
- Pregnancy or breastfeeding
- Recent childbirth (within the last six months)
- Patient already practicing yoga or having practiced it in the last six months
- Abdominal or spinal surgery in the last six months
- Motor neurological deficit
- Sphincter deficit
Show all 11Show fewer
- Any other somatic pathology preventing the practice of physiotherapy or yogatherapy according to the opinion of the evaluating clinician
- Depressive syndrome requiring specific treatment
- Non-affiliation to a social security scheme (beneficiary or beneficiary) or to another social protection scheme
- Patient deprived of liberty by judicial or administrative decision or under legal protection (guardianship, safeguard of justice)
- Currently participating in or in a period of exclusion from: another interventional research involving human participants, a clinical trial on a medical product for human, a clinical investigation on a medical device. Participation in non-interventional research is authorized.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 3 recruiting
- Recruiting
Hôpital Avicenne
Bobigny, 93000
Nathalie SAIDENBERG-KERMANAC'H, +1 48 95 54 44 ext. +33, nathalie.saidenberg@aphp.fr
- Active, not recruiting
Hôpital Henri Mondor
Créteil, 94000
- Recruiting
Hôpital Henri Mondor
Créteil, 94010
Laura PINA-VEGAS, 1 49 81 47 04 ext. +33, laura.pinavegas@aphp.fr
- Active, not recruiting
Hôpital Pitié Salpetrière
Paris, 75013
- Recruiting
Hôpital Cochin
Paris, 75014
Olivier FOGEL, 1 58 41 25 63 ext. +33, olivier.fogel@aphp.fr
About this study
Official title: Effects of Yoga Therapy in Rehabilitation Compared to Physiotherapy in Moderate Axial Spondyloarthritis (axSPA): a Randomized Controlled Multicenter Study.
A few studies have evaluated the effectiveness of yoga therapy in patients with axial spondyloarthritis (axSPA). On the other hand, studies conducted in other chronic rheumatisms such as low back pain, rheumatoid arthritis or other conditions such as cancer have shown that yogatherapy can have a effective action on the physical and psychological level.
Yogatherapy is a non-drug "body-mind" approach that would be likely to improve the physical symptoms (pain, stiffness, in particular spinal and pelvic), internal organs (colitis) and psychological symptoms as well as the perception of fatigue of people with axSPA. A 2021 study showed the feasibility and acceptability of regular yogatherapy practice in patients with axSPA.
It is therefore necessary to conduct randomized controlled studies to assess the effectiveness of this management strategy.
Read the detailed description
The term axial spondyloarthritis (axSPA) encompasses various inflammatory diseases of the spine, including ankylosing spondyloarthritis (AS) and non-radiographic axial spondyloarthritis (nr-axSPA).
axSPA is a chronic inflammatory joint disease affecting the axial skeleton. It is the second cause of chronic inflammatory rheumatism and affects 0.5 to 2% of the general population. It generally affects young adults, with a male predominance (2 men for 1 woman).
axSPA can lead to physical consequences (fatigue, pain, stiffness, with in particular serious damage to the spine causing functional impairment, etc.) and psychological consequences (anxiety, depression). It is responsible for a disability and a mediocre quality of life with, moreover, a significant socio-economic impact. In France, it is one of the long-term illnesses and may require heavy treatment.
The medicinal therapeutic side, taken care of by rheumatologists specializing in this pathology, has evolved a lot (from non-steroidal anti-inflammatory drugs [NSAIDs] to anti-tumor necrosis factor [anti-TNF] and anti-interleukin 17 [anti-IL 17]), allowing notable improvements. It is now a question of also developing the non-drug therapeutic side, to contribute to improving the quality of life, thus meeting the demand of patients with chronic diseases.
Information and therapeutic education occupy an important place, with results in favor of an improvement in the management of these diseases.
The recommendations emphasize that the non-pharmacological treatment of axSPA should include regular physical exercise, that individual and group physical therapy sessions should be considered as well as self-exercises.
Several randomized controlled trials have shown that physical therapy with various modalities has positive effects on pain and AS function. Physical therapy therefore also seems to play an important role in the management of patients. It prevents stiffness and improves functional capacity and quality of life.
Physical therapy should be initiated as soon as axSPA is diagnosed and regular exercise should form the basis of management. The review by Zochling et al. as well as a systematic review showed that exercises have positive effects on BASFI, BASDAI functions, pain and mobility. A Cochrane review on the role of physiotherapy interventions in SPA also concluded that physical therapy was beneficial. Physical activity, self-exercises and physiotherapy are part of the 2022 recommendations of the French Society of Rheumatology. Beneficial effects on disease activity were observed in axSPA, with good tolerance for intense exercise.
Recently an Indian team evaluated the effectiveness of online yogatherapy with 60 min structured modules on patients with axSPA for 3 months, with a significant improvement in the BASDAI score.
- Conditions
- Axial Spondyloarthritis (axSPA)
- Being tested
- Yogatherapy, Physiotherapy
- Keywords
- Yogatherapy, Ankylosing Spondyloarthritis, Physiotherapy, Yoga, Rheumatism
- Medical subject headings
- Axial Spondyloarthritis, Spondylitis, Ankylosing, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogatherapyProcedure or surgery
The experimental arm will benefit from support by a physiotherapist trained in yoga, in a group for ten weeks with two weekly sessions of approximately 1 hour each. A new yoga program adapted for the axSPA will be implemented.
PhysiotherapyProcedure or surgery
The comparator arm will benefit from support by a physiotherapist, in groups for ten weeks at the rate of two weekly sessions of approximately 1 hour each. An already existing program adapted for the axSPA will be implemented.
| Study group | Role | What they receive |
|---|---|---|
| Yogatherapy | Experimental | Randomization of 36 patients in the yogatherapy group. Receives: Procedure: Yogatherapy |
| Physiotherapy | Active comparator | Randomization of 36 patients in the physiotherapy group. Receives: Procedure: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the axSPA global activity score (fatigue, pain, stiffness)
Change in the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) score, via a self-administered questionnaire that assesses the "activity" of the disease (6 items, max score = 100, the higher the score the more disabling the disease).
Measured: Between the 2 month visit and the 5 month visit.
Secondary outcomes (14)
Evolution of the axSPA global activity score (fatigue, pain, stiffness)
Change in the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) score, via a self-administered questionnaire that assesses the "activity" of the disease (6 items, max score = 100, the higher the score the more disabling the disease).
Measured: Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
Functional impact
Change in self-assessment of functional capacity during daily tasks via the BASFI score (Bath Ankylosing Spondylitis disease Functional Index) (10 items, max score = 10, the higher the score the more disabling the disease).
Measured: Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
Health-related quality of life
Change in the patient's self-assessment via the generic SF-36 scale (Short Form-36 scale) (36 items, max score = 100, the higher the score the better the perception of quality of life).
Measured: Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
Anxiety and depression
Change in the patient's self-assessment via the HAD scale (Hospital Anxiety and Depression scale) (14 items, max anxiety score = 21, max depression score = 21, the higher the score the more anxiety and depressive disorders are marked).
Measured: Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
Respiratory capacity
Measurement of chest expansion.
Measured: Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
Spinal and axial mobility (maximum active amplitudes - sagittal plane)
Change in measurement of maximum active amplitudes in orthostatism of the thoraco-lumbar spine in the sagittal (flexion/extension) plane.
Measured: Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
Spinal and axial mobility (degrees of kyphosis and lordosis)
Change in measurement of the degrees of kyphosis and lordosis while standing.
Measured: Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
Spinal and axial mobility (maximum active amplitudes - frontal plane)
Change in measurement of maximum active amplitudes in orthostatism of the thoraco-lumbar spine in the frontal (lateral inclinations) plane.
Measured: Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
Spinal and axial mobility (podobarometric treadmill)
Change in measurement of the spatiotemporal analysis of gait on a podobarometric treadmill.
Measured: Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
Axial mobility
Change in BASMI (Bath Ankylosing Spondylitis Metrology Index) score (5 items, max score = 10, the higher the score the more restricted the axial mobility).
Measured: Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
Follow-up of the therapeutic strategy
Change in therapeutic strategy.
Measured: Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
Drug consumption monitoring
Change in drug consumption.
Measured: Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
Sleep quality
Change in QESL score (Leeds Sleep Assessment Questionnaire) (10 visual analog scales, minimum = -50, maximum = 50, the higher the score the better the sleep).
Measured: Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
Adherence to the practice of yogatherapy of patients randomized in this group
Degree of adherence to the practice of yogatherapy collected through responses to a short self-questionnaire.
Measured: After physical rehabilitation : at 5 month and 11 month visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start27 Aug 2024
- Primary completion6 Feb 2028 (estimated)
- Study completion27 Aug 2028 (estimated)
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.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Model description
- Multicenter, comparative, randomized study in two parallel groups (yogatherapy versus physiotherapy), of superiority.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Petra PAREJO MARGALLO, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083090
- Sponsor's protocol ID
- APHP210998
- Acronym
- YOKISPA
- Status last verified
- Sep 2025
- First submitted
- 21 Jul 2023
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Datas are own by Assistance Publique - Hôpitaux de Paris, please contact sponsor for further information.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Yoga Therapy in Rehabilitation Compared to Physiotherapy in Moderate Axial Spondyloarthritis (axSPA): a Randomized Controlled Multicenter Study.
- ClinicalTrials.gov ID
- NCT06083090
- Acronym / sponsor ID
- YOKISPA / APHP210998
- Conditions
- Axial Spondyloarthritis (axSPA)
- Keywords
- Yogatherapy, Ankylosing Spondyloarthritis, Physiotherapy, Yoga, Rheumatism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 27 Aug 2024 (actual)
- Primary completion
- 6 Feb 2028 (estimated)
- Study completion
- 27 Aug 2028 (estimated)
- First posted
- 13 Oct 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.
A few studies have evaluated the effectiveness of yoga therapy in patients with axial spondyloarthritis (axSPA). On the other hand, studies conducted in other chronic rheumatisms such as low back pain, rheumatoid arthritis or other conditions such as cancer have shown that yogatherapy can have a effective action on the physical and psychological level.
Yogatherapy is a non-drug "body-mind" approach that would be likely to improve the physical symptoms (pain, stiffness, in particular spinal and pelvic), internal organs (colitis) and psychological symptoms as well as the perception of fatigue of people with axSPA. A 2021 study showed the feasibility and acceptability of regular yogatherapy practice in patients with axSPA.
It is therefore necessary to conduct randomized controlled studies to assess the effectiveness of this management strategy.
Detailed description
The term axial spondyloarthritis (axSPA) encompasses various inflammatory diseases of the spine, including ankylosing spondyloarthritis (AS) and non-radiographic axial spondyloarthritis (nr-axSPA).
axSPA is a chronic inflammatory joint disease affecting the axial skeleton. It is the second cause of chronic inflammatory rheumatism and affects 0.5 to 2% of the general population. It generally affects young adults, with a male predominance (2 men for 1 woman).
axSPA can lead to physical consequences (fatigue, pain, stiffness, with in particular serious damage to the spine causing functional impairment, etc.) and psychological consequences (anxiety, depression). It is responsible for a disability and a mediocre quality of life with, moreover, a significant socio-economic impact. In France, it is one of the long-term illnesses and may require heavy treatment.
The medicinal therapeutic side, taken care of by rheumatologists specializing in this pathology, has evolved a lot (from non-steroidal anti-inflammatory drugs [NSAIDs] to anti-tumor necrosis factor [anti-TNF] and anti-interleukin 17 [anti-IL 17]), allowing notable improvements. It is now a question of also developing the non-drug therapeutic side, to contribute to improving the quality of life, thus meeting the demand of patients with chronic diseases.
Information and therapeutic education occupy an important place, with results in favor of an improvement in the management of these diseases.
The recommendations emphasize that the non-pharmacological treatment of axSPA should include regular physical exercise, that individual and group physical therapy sessions should be considered as well as self-exercises.
Several randomized controlled trials have shown that physical therapy with various modalities has positive effects on pain and AS function. Physical therapy therefore also seems to play an important role in the management of patients. It prevents stiffness and improves functional capacity and quality of life.
Physical therapy should be initiated as soon as axSPA is diagnosed and regular exercise should form the basis of management. The review by Zochling et al. as well as a systematic review showed that exercises have positive effects on BASFI, BASDAI functions, pain and mobility. A Cochrane review on the role of physiotherapy interventions in SPA also concluded that physical therapy was beneficial. Physical activity, self-exercises and physiotherapy are part of the 2022 recommendations of the French Society of Rheumatology. Beneficial effects on disease activity were observed in axSPA, with good tolerance for intense exercise.
Recently an Indian team evaluated the effectiveness of online yogatherapy with 60 min structured modules on patients with axSPA for 3 months, with a significant improvement in the BASDAI score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter, comparative, randomized study in two parallel groups (yogatherapy versus physiotherapy), of superiority.
| Arm | Type | Receives |
|---|---|---|
| Yogatherapy | Experimental | Procedure: YogatherapyRandomization of 36 patients in the yogatherapy group. |
| Physiotherapy | Active comparator | Procedure: PhysiotherapyRandomization of 36 patients in the physiotherapy group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- French-speaking patient aged 18 and over
- Patient with axial spondyloarthritis (axSPA) according to Assessment of SpondyloArthritis International Society, diagnosed by a rheumatologist
- "Moderately active" to "active" form of axSPA (basic BASDAI \> 3)
- Stable disease: No recent or foreseeable introduction in the next 6 months of drug treatments for axSPA (excluding analgesics)
- Absence of disabling stress urinary incontinence
Key exclusion criteria (11 listed)
- Pregnancy or breastfeeding
- Recent childbirth (within the last six months)
- Patient already practicing yoga or having practiced it in the last six months
- Abdominal or spinal surgery in the last six months
- Motor neurological deficit
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 |
|---|---|---|
| YogatherapyThe experimental arm will benefit from support by a physiotherapist trained in yoga, in a group for ten weeks with two weekly sessions of approximately 1 hour each. A new yoga program adapted for the axSPA will be implemented. | Procedure or surgery | Yogatherapy |
| PhysiotherapyThe comparator arm will benefit from support by a physiotherapist, in groups for ten weeks at the rate of two weekly sessions of approximately 1 hour each. An already existing program adapted for the axSPA will be implemented. | Procedure or surgery | Physiotherapy |
Primary outcome
Evolution of the axSPA global activity score (fatigue, pain, stiffness)
Time frame: Between the 2 month visit and the 5 month visit.
Change in the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) score, via a self-administered questionnaire that assesses the "activity" of the disease (6 items, max score = 100, the higher the score the more disabling the disease).
14 secondary outcomes
Evolution of the axSPA global activity score (fatigue, pain, stiffness)
Time frame: Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
Functional impact
Time frame: Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
Health-related quality of life
Time frame: Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
Anxiety and depression
Time frame: Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
Respiratory capacity
Time frame: Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
Spinal and axial mobility (maximum active amplitudes - sagittal plane)
Time frame: Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
Spinal and axial mobility (degrees of kyphosis and lordosis)
Time frame: Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
Spinal and axial mobility (maximum active amplitudes - frontal plane)
Time frame: Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
Spinal and axial mobility (podobarometric treadmill)
Time frame: Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
Axial mobility
Time frame: Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
Follow-up of the therapeutic strategy
Time frame: Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
Drug consumption monitoring
Time frame: Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
Sleep quality
Time frame: Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
Adherence to the practice of yogatherapy of patients randomized in this group
Time frame: After physical rehabilitation : at 5 month and 11 month visits.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: No. Datas are own by Assistance Publique - Hôpitaux de Paris, please contact sponsor for further information.
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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.
Petra PAREJO MARGALLO study director
Assistance Publique - Hôpitaux de Paris
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yogatherapy and Physiotherapy in people with Axial Spondyloarthritis (axSPA), run by Assistance Publique - Hôpitaux de Paris at 5 sites in France.
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 7 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Petra PAREJO MARGALLO (+33 1 40 27 43 13, petri.parejo-margallo@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of the axSPA global activity score (fatigue, pain, stiffness) (time frame: Between the 2 month visit and the 5 month visit.). 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 1 Oct 2025.