Axial Spondyloarthritis Clinical Trial
— SatiSpActionOfficial title:
Randomized Controlled Study of a Video Coaching Program of Physical Activity in Patients Suffering From Axial Spondyloarthritis
The primary objective of the study is to demonstrate the beneficial effect of a 3 months home-based physical exercise program supervised by online videos, in addition to the usual recommendations, in comparison with usual physical activity as recommended by the WHO. The secondary objectives of the study are : 1. to compare the following criteria between 2 groups at 3 and 6 months: - quality of life; - other measures of disease activity ; - sleep quality ; - walking ability - muscle strength of; - professional activity; - cost of cares; - evolution of weight, BMI and waist. 2. to evaluate the observance of physical activity program and its tolerance at 3 and 6 months.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | February 2024 |
Est. primary completion date | February 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Patient between 18 and 65 years; - Patient can read and understand French; - Signed informed consent form to participate in the study; - Axial spondylarthritis according to ASAS criteria; - Patient with a BASDAI score between 2.5 and 5; - No change of biotherapy anti-TNF or anti-IL17 during the 3 months preceding the inclusion; - Patient equipped with an internet access; - Medical certificate of proposed physical activities. Exclusion Criteria: - All diseases (cardiovascular disease or chronic neurological disease or others) contraindicating the requested exercises according to physician; - Axial spondyloarthritis in remission defined by a BASDAI < 2.5/10 or in excessive inflammatory activity, defined by BASDAI > 5/10; - Pregnant woman (positive pregnant test) or woman try to conceive in following 6 months; - Patient with articular prosthesis; - Patient who already participate in a specific exercise program or practice a sport (including Yoga or Tai Chi) more than one hour per week; - Severe obesity ( BMI > 35); - Patient without health insurance; - Patient legally unable. |
Country | Name | City | State |
---|---|---|---|
France | Service de rhumatologie, Hôpital Ambroise Paré | Boulogne-Billancourt | Hauts-de-Seine |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients responding to the "ASAS 20" criterion at 3 months | The primary outcome measure will be the proportion of patients simultaneously satisfying both criteria : at least 20% improvement improvement of at least 10 points on visual analog scale in the following domains: overall evaluation by the patient, visual analog scale (pain scale), Bath Ankylosing Spondylitis Functional Index (BASFI), and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). |
at 3 months | |
Secondary | Ankylosing Spondylitis Disease Activity : (BASDAI) (PRO) | Ankylosing Spondylitis Disease Activity will be assessed with the Bath Ankylosing Spondylitis Disease Activity (BASDAI) auto-questionnaire assessing the inflammatory activity of the disease. | at baseline, 3 months and 6 months | |
Secondary | Ankylosing Spondylitis Disease Activity : (ASDAS CRP) (PRO) | Ankylosing Spondylitis Disease Activity will be assessed with the Ankylosing Spondylitis Disease Activity Score (ASDAS CRP) auto-questionnaire assessing the inflammatory activity of the disease. | at baseline, 3 months and 6 months | |
Secondary | Bath Ankylosing Spondylitis Functional Index (BASFI) (PRO) | Data collected with the Bath Ankylosing Spondylitis Functional Index (BASFI) auto-questionnaire assessing the functional impact of disease. | at baseline, 3 months and 6 months | |
Secondary | Fatigue (PRO) | Fatigue will be assessed with a Visual Analogue Scale | at baseline, 3 months and 6 months | |
Secondary | Health assessment: HAQ-S (PRO) | SpA-related health will be assessed with the Health Assessment Questionnaire for the Spondyloarthropathies (HAQ-S) | at baseline, 3 months and 6 months | |
Secondary | SPA impact on general health: ASAS-HI (PRO) | General health will be assessed with the ASAS Health Index auto-questionnaire | at baseline, 3 months and 6 months | |
Secondary | Work Productivity and Activity : WPAI (PRO) | Work Productivity and Activity will be assessed with the Work Productivity and Activity Impairment (WPAI) auto-questionnaire | at baseline, 3 months and 6 months | |
Secondary | Sleep quality: PSQI | Sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI) auto-questionnaire | at baseline, 3 months and 6 months | |
Secondary | Physical activity: IPAQ (PRO) | Physical activity will be assessed with the International Physical Activity Questionnaire (IPAQ) - Short Form and Long Form auto-questionnaires | at baseline, 3 months and 6 months | |
Secondary | Analgesic and anti-inflammatory drug intake | Following drugs intake will be collected: non-steroidal anti-inflammatory drugs (NSAIDs) corticosteroids |
at 3 months and 6 months | |
Secondary | Anthropometric measures: BASMI | The functional impact of SpA will be assessed with the Bath Ankylosing Spondylitis Metrology Index (BASMI) | at baseline, 3 months and 6 months | |
Secondary | Anthropometric measures: Enthesitis: MASES | Entesis involvement will be assessed with the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) | at baseline, 3 months and 6 months | |
Secondary | Anthropometric measures: Muscle strength: dynamometer | Muscle strength of the upper and lower limbs will be assessed with a dynamometer | at baseline, 3 months and 6 months | |
Secondary | Anthropometric measures: 6-minutes walk test | Walking ability will be assessed with the 6-minutes walking test. | at baseline, 3 months and 6 months | |
Secondary | Anthropometric measures: Body mass index (BMI) | Weight, height and waist size will be collected to calculate the BMI of patients. | at baseline, 3 months and 6 months |
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