Benefit of Adapted Physical Activity for Patients Suffering From Ankylosing Spondylitis

NCT04089774 | Unknown

• 1 other identifier: ID RCB 2019-A00138-49
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The mean variation of the BASFI score (Bath Ankylosing Spondylitis Functional Index) over a period of 18 months

  The primary endpoint is the mean change in BASFI score (functional index of ankylosing spondylitis) between 12 months of management (or M12), and baseline (or M0), compared between the 2 groups. It will be noted BASFI (M12-M0). Patients follow-up will be done during 18 months. BASFI is a self-administered questionnaire that assesses the functional impact of the disease on the patient's life. This tool consists of 10 questions to answer a visual evaluation of 10 cm (0 for "easy" and 10 for "impossible").

  18 MONTHS

Secondary Outcomes (9)

• The mean variation of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

  18 MONTHS

• The mean variation of C-reactive protein (CRP) and sedimentation rate (VS) over a period of 18 months

  18 MONTHS

• The mean variation of ASDAS (Ankylosing Spondylitis Disease Activity Score).

  18 MONTHS

• The mean variation of the score of the Visual Analogue Scale of Global Appreciation (EVA-AG) over a period of 18 months.

  18 MONTHS

• The mean variation in NSAID consumption (Anti-Inflammatory Non Steroidal) over a period of 18 months.

  18 MONTHS

Study Arms (2)

Adapted Physical Activity (APA)

EXPERIMENTAL

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

Behavioral: Adapted Physical Activity (APA)

Kiné

NO INTERVENTION

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

Interventions

Adapted Physical Activity (APA) 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

Adapted Physical Activity (APA)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital St. Joseph, Marseille, France: lead

Study Sites (1)

Hopital Saint Joseph

Marseille, Bouches DU Rhone, 13008, France

RECRUITING

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Central Study Contacts

ASSELATE BELKACEM, RESEARCH

CONTACT

0033491807016; basselate@hopital-saint-joseph.fr

ASSELATE BELKACEM

CONTACT

0033491807016; basselate@hopital-saint-joseph.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator, Rheumatology department head

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: September 13, 2019
• Study Start: May 14, 2019
• Primary Completion: June 14, 2022
• Study Completion: June 14, 2022
• Last Updated: September 13, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)