Yogatherapy
ProcedureThe 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.
NCT Number: NCT06083090
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Hôpital Avicenne, Bobigny, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 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).
Time frame: 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).
Time frame: Between 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).
Time frame: Between 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).
Time frame: Between 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).
Time frame: Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
Measurement of chest expansion.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Between 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).
Time frame: Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
Change in therapeutic strategy.
Time frame: Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
Change in drug consumption.
Time frame: Between 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).
Time frame: After 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.
Contact information is provided by the study sponsor or research team.
Charlotte PAUWELS
CONTACT
Petra PAREJO MARGALLO
CONTACT
Assistance Publique - Hôpitaux de Paris
Other
Effects of Yoga Therapy in Rehabilitation Compared to Physiotherapy in Moderate Axial Spondyloarthritis (axSPA): a Randomized Controlled Multicenter Study.
Acronym: YOKISPA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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