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

NCT06083090 | Recruiting

• 1 other identifier: APHP210998
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Axial Spondyloarthritis (axSPA)

Keywords

Yogatherapy; Ankylosing Spondyloarthritis; Physiotherapy; Yoga; Rheumatism

Outcome Measures

Primary Outcomes (1)

• 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).

  Between the 2 month visit and the 5 month visit.

Secondary Outcomes (14)

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

  Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.

• Functional impact

  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

  Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.

• Anxiety and depression

  Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.

• Respiratory capacity

  Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.

Study Arms (2)

Yogatherapy

EXPERIMENTAL

Randomization of 36 patients in the yogatherapy group.

Procedure: Yogatherapy

Physiotherapy

ACTIVE COMPARATOR

Randomization of 36 patients in the physiotherapy group.

Procedure: Physiotherapy

Interventions

Yogatherapy PROCEDURE

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.

Yogatherapy

Physiotherapy PROCEDURE

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.

Physiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (5)

Hôpital Avicenne

Bobigny, 93000, France

RECRUITING

Hôpital Henri Mondor

Créteil, 94000, France

ACTIVE NOT RECRUITING

Hôpital Henri Mondor

Créteil, 94010, France

RECRUITING

Hôpital Pitié Salpetrière

Paris, 75013, France

ACTIVE NOT RECRUITING

Hôpital Cochin

Paris, 75014, France

RECRUITING

MeSH Terms

Conditions

Axial Spondyloarthritis; Spondylitis, Ankylosing; Rheumatic Diseases

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Petra PAREJO MARGALLO

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Petra PAREJO MARGALLO

CONTACT

+33 1 40 27 43 13; petri.parejo-margallo@aphp.fr

Charlotte PAUWELS

CONTACT

+33 1 49 81 30 66; charlotte.pauwels@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The evaluators of the secondary endpoints relating to measurements of respiratory and biomechanical parameters will be blinded to the patient randomization group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, comparative, randomized study in two parallel groups (yogatherapy versus physiotherapy), of superiority.

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: October 13, 2023
• Study Start: August 27, 2024
• Primary Completion (Estimated): February 6, 2028
• Study Completion (Estimated): August 27, 2028
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)