Clinical trial NCT04089774: Benefit of Adapted Physical Activity for Patients Suffering From Ankylosing Spondylitis
Official title: Comparison of the Benefit Experienced by Patients With Ankylosing Spondylitis, Under Biotherapy, During Management by an Adapted Physical Activity Compared to a Standard Treatment by Kinesitherapy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ankylosing Spondylitis
Lead sponsor: Hospital St. Joseph, Marseille, France
Sponsor class: OTHER
First posted: 2019-09-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The current management of Spondylarthritis Ankylosant (SA), according to the recommendations of the HAS (High Authority of Health), must be a multidisciplinary global approach coordinated by the rheumatologist combining a pharmacological aspect (NSAID, analgesics, biotherapy ...) and not pharmacological (physical treatments, educational approaches, social measures ...). The therapeutic aim of this management is to achieve a low level of activity of the disease and a decrease of the repercussion of this one in the daily life of the patient.

The standard physical treatment currently provided is physiotherapy. This can be prescribed throughout the disease by the rheumatologist, adapted to the stage of AS and the clinical condition of the patient. The medical teams note in their daily practice that there may be a lack of attendance of patients at prescribed physiotherapy sessions. This has been confirmed in research on certain chronic rheumatic diseases, including AS, for which patients became less adherent to physical treatments and thus lost the expected benefits, particularly in terms of the functional impact of AS in the patient's daily life. (BASFI). Various studies have also shown that combining several physical activities (including aerobic and muscle building) or / and performing them in groups at a regular frequency (three times a week) could significantly improve several AS parameters, including BASFI.

From these different findings, we hypothesized that a multidisciplinary treatment combining a "cardio training" with muscle strengthening, supervised by qualified sports coaches, for a year, could reduce the impact of SA in the daily life of patients balanced by a biotherapy, compared to standard physiotherapy. This original care is part of the Adapted Physical Activity (APA), whose application decree came into force on March 1, 2017 and allows doctors to prescribe a physical therapy tailored to the needs of the patient. At present, the APA remains at the expense of the patients in ALD and in some cases, it can be supported, partially or totally, by the complementary health. APA could therefore be an alternative and / or complementary to physiotherapy as a physical therapy in the management of AS, in addition to pharmacological treatments.


Eligibility criteria: Inclusion Criteria:

* Be between 18 and 60 years old
* Present Axial Spondylitis meeting the criteria of ASAS 2009
* Be on treatment with biotherapy, stable dose for at least 6 months
* Complete the ALD criteria
* Have a BASFI score at inclusion ≤ 5
* Have signed the consent form
* Being able to be compliant to the study schedule (mobile and available)
* To be clinically stable for at least 6 months
* Affiliation to a social security scheme or beneficiary of such a scheme
* Does not present a contraindication to the practice of a physical activity

Exclusion Criteria:

* Regularly practice a sports activity (≥ 1hour / week)
* Have a severe handicap limiting the gestures of daily life (dressing, walking, etc ...)
* Have another significant osteo-articular pathology (Rheumatoid arthritis osteoarthritis, hip prosthesis ...)
* Have a bamboo column
* Being pregnant or planning to be pregnant in the coming year

Primary outcomes:
measure: The mean variation of the BASFI score (Bath Ankylosing Spondylitis Functional Index) over a period of 18 months
timeFrame: 18 MONTHS
Secondary outcomes:
measure: The mean variation of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: 18 MONTHS
measure: The mean variation of C-reactive protein (CRP) and sedimentation rate (VS) over a period of 18 months
timeFrame: 18 MONTHS
measure: The mean variation of ASDAS (Ankylosing Spondylitis Disease Activity Score).
timeFrame: 18 MONTHS
measure: The mean variation of the score of the Visual Analogue Scale of Global Appreciation (EVA-AG) over a period of 18 months.
timeFrame: 18 MONTHS
measure: The mean variation in NSAID consumption (Anti-Inflammatory Non Steroidal) over a period of 18 months.
timeFrame: 18 MONTHS
measure: The mean variation in the consumption of analgesics.
timeFrame: 18 MONTHS
measure: The average variation in medical consumption over a period of 18 months
timeFrame: 18 MONTHS
measure: Variation of items in the Patient Questionnaire.
timeFrame: 18 MONTHS
measure: The average change in scores on the Quality of Life Questionnaire (short form) SF-12.
timeFrame: 18 MONTHS
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hopital Saint Joseph
state: Bouches DU Rhone
Study officials:
References: