Actively Recruiting
Effects of Yoga Therapy Compared to Physiotherapy in Moderate Axial Spondyloarthritis: A Randomized Controlled Multicenter Study
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-10-01
72
Participants Needed
5
Research Sites
29 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Axial spondyloarthritis (axSPA) is a chronic inflammatory joint disease affecting the spine, including types like ankylosing spondyloarthritis and non-radiographic forms. It mainly affects young adults and can cause fatigue, pain, stiffness, and psychological effects such as anxiety and depression. This research evaluates the effects of yoga therapy compared to physiotherapy on physical and psychological symptoms in patients with moderate axSPA to explore non-drug treatment options that may improve quality of life. Participants are randomly assigned to two groups: one receiving yogatherapy led by a physiotherapist trained in yoga, with group sessions twice weekly for ten weeks using a program adapted for axSPA; the other receiving physiotherapy in groups twice weekly for ten weeks using an existing axSPA-adapted program. Both treatments last approximately one hour per session. During the study, participants will be assessed for changes in axSPA activity (fatigue, pain, stiffness) between 2 and 5 months, with follow-ups up to 11 months. Researchers will also evaluate function, quality of life, mental health, respiratory capacity, spinal mobility, drug use, sleep quality, and adherence to yogatherapy. These many assessments aim to understand the impact of these rehabilitation methods on patients' well-being over time.
CONDITIONS
Brief Title
Effects of Yoga Therapy in Rehabilitation Compared to Physiotherapy in Moderate Axial Spondyloarthritis (axSPA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- French-speaking patient aged 18 and over
- Diagnosis of axial spondyloarthritis by a rheumatologist according to Assessment of SpondyloArthritis International Society
- Moderate to active disease with BASDAI score greater than 3
- Stable disease with no planned new drug treatments for axSPA in the next 6 months (excluding painkillers)
- No disabling stress urinary incontinence
- Able to attend study sessions based on location and organization
- Informed and signed consent to participate in the study
You will not qualify if you...
- Pregnant or breastfeeding
- Childbirth within the last six months
- Currently practicing yoga or practiced it in the last six months
- Abdominal or spinal surgery in the last six months
- Motor neurological deficit
- Sphincter deficit
- Any other medical condition preventing physiotherapy or yogatherapy as judged by the clinician
- Depressive syndrome requiring specific treatment
- Not affiliated to a social security or other social protection scheme
- Deprived of liberty by judicial or administrative decision or under legal protection
- Participating in or excluded from another interventional clinical trial or research involving medical products or devices
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 10 weeks
Participants receive either yogatherapy or physiotherapy in groups for ten weeks with two weekly sessions of approximately 1 hour each.
Two sessions per week (in-person)
Duration - Up to 9 months after treatment
Participants are assessed for effects on disease activity, function, quality of life, and other health measures after completing treatment.
Visits at 2 months, 5 months, and 11 months after starting treatment
Trial Site Locations
Total: 5 locations
1
Hôpital Avicenne
Bobigny, France, 93000
Actively Recruiting
2
Hôpital Henri Mondor
Créteil, France, 94000
Active, Not Recruiting
3
Hôpital Henri Mondor
Créteil, France, 94010
Actively Recruiting
4
Hôpital Pitié Salpetrière
Paris, France, 75013
Active, Not Recruiting
5
Hôpital Cochin
Paris, France, 75014
Actively Recruiting
Research Team
P
Petra PAREJO MARGALLO
C
Charlotte PAUWELS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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