Benefit of Adapted Physical Activity for Patients Suffering From Ankylosing Spondylitis

NCT ID: NCT04089774

Last Updated: 2019-09-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-14
• Study Completion Date: 2022-06-14

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.

Conditions

Ankylosing Spondylitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Adapted Physical Activity (APA)

Supported by an Adapted Physical Activity (APA), at the rate of 3 sessions per week supervised by the association SCO STE MARGUERITE, spread over 12 months

Group Type: EXPERIMENTAL

Adapted Physical Activity (APA)

Intervention Type: BEHAVIORAL

Supported by an Adapted Physical Activity (APA), at the rate of 3 sessions per week supervised by the association SCO STE MARGUERITE, spread over 12 months

Kiné

Standard physiotherapy treatment, at least 20 sessions, renewed at least once, spread over 12 months

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Adapted Physical Activity (APA)

Supported by an Adapted Physical Activity (APA), at the rate of 3 sessions per week supervised by the association SCO STE MARGUERITE, spread over 12 months

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital St. Joseph, Marseille, France

OTHER

Sponsor Role: lead

Responsible Party

Denis Arniaud

principal investigator, Rheumatology department head

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hopital Saint Joseph

Marseille, Bouches DU Rhone, France

Site Status: RECRUITING

Countries

France

Central Contacts

ASSELATE BELKACEM, RESEARCH

Role: CONTACT

basselate@hopital-saint-joseph.fr

0033491807016

ASSELATE BELKACEM

Role: CONTACT

basselate@hopital-saint-joseph.fr

0033491807016

Facility Contacts

ASSELATE BELKACEM

Role: primary

basselate@hopital-saint-joseph.fr

00491807016

Other Identifiers

ID RCB 2019-A00138-49

Identifier Type: -

Identifier Source: org_study_id