Ireland
--:--IST
Recruiting Not applicable

Effects of Yoga Therapy in Rehabilitation Compared to Physiotherapy in Moderate Axial Spondyloarthritis (axSPA)

NCT06083090 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2024-08-27
Last updated
2025-10-01

Condition(s) studied

Axial Spondyloarthritis (axSPA)

Investigational drug(s) / intervention(s)

YogatherapyPhysiotherapy

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.

Study 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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.

Primary outcome measure(s)

  • Evolution of the axSPA global activity score (fatigue, pain, stiffness) — 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).

Trial sites (5)

FacilityCityRegionStatus
Hôpital Avicenne Bobigny France Recruiting
Hôpital Henri Mondor Créteil France Active Not Recruiting
Hôpital Henri Mondor Créteil France Recruiting
Hôpital Pitié Salpetrière Paris France Active Not Recruiting
Hôpital Cochin Paris France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06083090 on ClinicalTrials.gov ↗ ← All trials in France