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

Effects of Yoga Therapy in Rehabilitation Compared to Physiotherapy in Moderate Axial Spondyloarthritis (axSPA): a Randomized Controlled Multicenter Study.

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06083090
Acronym
YOKISPA
Enrollment
72
Registered
2023-10-13
Start date
2024-08-27
Completion date
2028-08-27
Last updated
2025-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Axial Spondyloarthritis (axSPA)

Keywords

Yogatherapy, Ankylosing Spondyloarthritis, Physiotherapy, Yoga, Rheumatism

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.

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.

Interventions

PROCEDUREYogatherapy

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.

PROCEDUREPhysiotherapy

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.

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The evaluators of the secondary endpoints relating to measurements of respiratory and biomechanical parameters will be blinded to the patient randomization group.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
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).

Secondary

MeasureTime frameDescription
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.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).
Functional impactBetween the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.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).
Health-related quality of lifeBetween the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.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).
Respiratory capacityBetween the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.Measurement of chest expansion.
Spinal and axial mobility (maximum active amplitudes - sagittal plane)Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.Change in measurement of maximum active amplitudes in orthostatism of the thoraco-lumbar spine in the sagittal (flexion/extension) plane.
Spinal and axial mobility (degrees of kyphosis and lordosis)Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.Change in measurement of the degrees of kyphosis and lordosis while standing.
Anxiety and depressionBetween the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.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).
Spinal and axial mobility (podobarometric treadmill)Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.Change in measurement of the spatiotemporal analysis of gait on a podobarometric treadmill.
Axial mobilityBetween the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.Change in BASMI (Bath Ankylosing Spondylitis Metrology Index) score (5 items, max score = 10, the higher the score the more restricted the axial mobility).
Follow-up of the therapeutic strategyBetween the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.Change in therapeutic strategy.
Drug consumption monitoringBetween the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.Change in drug consumption.
Sleep qualityBetween the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.Change in QESL score (Leeds Sleep Assessment Questionnaire) (10 visual analog scales, minimum = -50, maximum = 50, the higher the score the better the sleep).
Adherence to the practice of yogatherapy of patients randomized in this groupAfter physical rehabilitation : at 5 month and 11 month visits.Degree of adherence to the practice of yogatherapy collected through responses to a short self-questionnaire.
Spinal and axial mobility (maximum active amplitudes - frontal plane)Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.Change in measurement of maximum active amplitudes in orthostatism of the thoraco-lumbar spine in the frontal (lateral inclinations) plane.

Countries

France

Contacts

Primary ContactPetra PAREJO MARGALLO
petri.parejo-margallo@aphp.fr+33 1 40 27 43 13
Backup ContactCharlotte PAUWELS
charlotte.pauwels@aphp.fr+33 1 49 81 30 66

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026