Effects of Yoga Therapy in Rehabilitation Compared to Physiotherapy in Moderate Axial Spondyloarthritis (axSPA)
NCT ID: NCT06083090
Last Updated: 2025-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
72 participants
INTERVENTIONAL
2024-08-27
2028-08-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Telerehabilitation and Face-to-Face Clinical Pilates-Based Exercise in Individuals With Axial Spondyloarthritis
NCT05006690
Effectiveness of Yoga and Combined Exercise in Rheumatoid Arthritis
NCT07072754
Video Coaching of Physical Activity in Axial Spondyloarthritis
NCT03965650
Effects of a Digital Exercise Intervention on Sleep and Physical Activity in Patients With Spondyloarthritis
NCT07034404
Health Technology to Improve Exercise in axSpA
NCT05504616
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Yogatherapy
Randomization of 36 patients in the yogatherapy group.
Yogatherapy
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.
Physiotherapy
Randomization of 36 patients in the physiotherapy group.
Physiotherapy
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Yogatherapy
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.
Physiotherapy
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Petra PAREJO MARGALLO
Role: STUDY_DIRECTOR
Assistance Publique - Hôpitaux de Paris
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hôpital Avicenne
Bobigny, , France
Hôpital Henri Mondor
Créteil, , France
Hôpital Henri Mondor
Créteil, , France
Hôpital Pitié Salpetrière
Paris, , France
Hôpital Cochin
Paris, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
APHP210998
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.