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临床试验/NCT04089774
NCT04089774Unknown不适用

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.

Hospital St. Joseph, Marseille, France2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年5月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
2
主要终点
The mean variation of the BASFI score (Bath Ankylosing Spondylitis Functional Index) over a period of 18 months

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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

干预措施: Adapted Physical Activity (APA) (Behavioral)

Kiné

No Intervention

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

结局指标

主要结局

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

时间窗: 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").

次要结局

  • 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 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)
  • The mean variation in the consumption of analgesics.(18 MONTHS)
  • The average change in scores on the Quality of Life Questionnaire (short form) SF-12.(18 MONTHS)
  • The mean variation of ASDAS (Ankylosing Spondylitis Disease Activity Score).(18 MONTHS)
  • The average variation in medical consumption over a period of 18 months(18 MONTHS)
  • Variation of items in the Patient Questionnaire.(18 MONTHS)

研究者

发起方
Hospital St. Joseph, Marseille, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

Denis Arniaud

principal investigator, Rheumatology department head

Hospital St. Joseph, Marseille, France

研究点 (2)

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