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

Primary Purpose

Axial Spondyloarthritis (axSPA)

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Yogatherapy
Physiotherapy
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Axial Spondyloarthritis (axSPA) focused on measuring Yogatherapy, Ankylosing Spondyloarthritis, Physiotherapy, Yoga, Rheumatism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Yogatherapy

    Physiotherapy

    Arm Description

    Randomization of 36 patients in the yogatherapy group.

    Randomization of 36 patients in the physiotherapy group.

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    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).
    Functional impact
    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
    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
    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
    Measurement of chest expansion.
    Spinal and axial mobility (maximum active amplitudes - sagittal plane)
    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)
    Change in measurement of the degrees of kyphosis and lordosis while standing.
    Spinal and axial mobility (maximum active amplitudes - frontal plane)
    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)
    Change in measurement of the spatiotemporal analysis of gait on a podobarometric treadmill.
    Axial mobility
    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
    Change in therapeutic strategy.
    Drug consumption monitoring
    Change in drug consumption.
    Sleep quality
    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
    Degree of adherence to the practice of yogatherapy collected through responses to a short self-questionnaire.

    Full Information

    First Posted
    July 21, 2023
    Last Updated
    October 12, 2023
    Sponsor
    Assistance Publique - Hôpitaux de Paris
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06083090
    Brief Title
    Effects of Yoga Therapy in Rehabilitation Compared to Physiotherapy in Moderate Axial Spondyloarthritis (axSPA)
    Acronym
    YOKISPA
    Official Title
    Effects of Yoga Therapy in Rehabilitation Compared to Physiotherapy in Moderate Axial Spondyloarthritis (axSPA): a Randomized Controlled Multicenter Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    April 2026 (Anticipated)
    Study Completion Date
    October 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Assistance Publique - Hôpitaux de Paris

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Axial Spondyloarthritis (axSPA)
    Keywords
    Yogatherapy, Ankylosing Spondyloarthritis, Physiotherapy, Yoga, Rheumatism

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Multicenter, comparative, randomized study in two parallel groups (yogatherapy versus physiotherapy), of superiority.
    Masking
    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.
    Allocation
    Randomized
    Enrollment
    72 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Yogatherapy
    Arm Type
    Experimental
    Arm Description
    Randomization of 36 patients in the yogatherapy group.
    Arm Title
    Physiotherapy
    Arm Type
    Active Comparator
    Arm Description
    Randomization of 36 patients in the physiotherapy group.
    Intervention Type
    Procedure
    Intervention Name(s)
    Yogatherapy
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Physiotherapy
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Evolution of the axSPA global activity score (fatigue, pain, stiffness)
    Description
    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.
    Secondary Outcome Measure Information:
    Title
    Evolution of the axSPA global activity score (fatigue, pain, stiffness)
    Description
    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.
    Title
    Functional impact
    Description
    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.
    Title
    Health-related quality of life
    Description
    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).
    Time Frame
    Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
    Title
    Anxiety and depression
    Description
    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.
    Title
    Respiratory capacity
    Description
    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.
    Title
    Spinal and axial mobility (maximum active amplitudes - sagittal plane)
    Description
    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.
    Title
    Spinal and axial mobility (degrees of kyphosis and lordosis)
    Description
    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.
    Title
    Spinal and axial mobility (maximum active amplitudes - frontal plane)
    Description
    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.
    Title
    Spinal and axial mobility (podobarometric treadmill)
    Description
    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.
    Title
    Axial mobility
    Description
    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.
    Title
    Follow-up of the therapeutic strategy
    Description
    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.
    Title
    Drug consumption monitoring
    Description
    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.
    Title
    Sleep quality
    Description
    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
    Between the 2 month visit and the 5 month visit. Between the 2 month visit and the 11 month visit.
    Title
    Adherence to the practice of yogatherapy of patients randomized in this group
    Description
    Degree of adherence to the practice of yogatherapy collected through responses to a short self-questionnaire.
    Time Frame
    After physical rehabilitation : at 5 month and 11 month visits.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Petra PAREJO MARGALLO
    Phone
    +33 1 49 81 80 51
    Email
    petri.parejo-margallo@aphp.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Charlotte PAUWELS
    Phone
    +33 1 49 81 30 66
    Email
    charlotte.pauwels@aphp.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Petra PAREJO MARGALLO
    Organizational Affiliation
    Assistance Publique Hôpitaux de Paris - Hôpitaux Universitaires Henri Mondor
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Datas are own by Assistance Publique - Hôpitaux de Paris, please contact sponsor for further information.

    Learn more about this trial

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

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