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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06083090

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Axial Spondyloarthritis (axSPA)	Procedure: Yogatherapy Procedure: Physiotherapy	N/A

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 NSAIDs to anti-TNF and 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

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.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2026

Anticipated Study Completion Date :

Oct 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Yogatherapy Randomization of 36 patients in the yogatherapy group.	Procedure: 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.
Active Comparator: Physiotherapy Randomization of 36 patients in the physiotherapy group.	Procedure: 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.

Arm

Intervention/Treatment

Experimental: Yogatherapy

Randomization of 36 patients in the yogatherapy group.

Procedure: 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.

Active Comparator: Physiotherapy

Randomization of 36 patients in the physiotherapy group.

Procedure: 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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 impact [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).
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.]
Change in the patient's self-assessment via the generic SF-36 scale (Short Form (36) Health Survey) (36 items, max score = 100, the higher the score the better the perception of quality of life).
Anxiety and depression [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).
Respiratory capacity [Between 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.
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.
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 mobility [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).
Follow-up of the therapeutic strategy [Between 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 monitoring [Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.]
Change in drug consumption.
Sleep quality [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).
Adherence to the practice of yogatherapy of patients randomized in this group [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

French-speaking patient aged 18 and over
Patient with axial spondyloarthritis (axSPA) according to ASAS, 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)