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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A01384-53 | Registry Identifier | IDRCB |
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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 :
to compare the following criteria between 2 groups at 3 and 6 months:
to evaluate the observance of physical activity program and its tolerance at 3 and 6 months.
The spondyloarthritides are a group of inflammatory rheumatic diseases, including ankylosing spondylitis, reactive arthritis, inflammatory bowel disease-related rheumatic disease, and psoriatic arthritis.
The frequence of axial spondyloarthritis is 0.41% in the french population. This disease is associated with a reduction of physical capacities and quality of life. NSAIDs or even biologic therapies do not always permit a sufficient control of the disease. Different physical exercise programs can be effective as an additional therapy for spondyloarthritis, with positive effects on spinal mobility as well as main disease activity and functional indices (BASDAI, BASFI and BASMI). The severity of the disease does not seem to influence significantly the patients' motivation in practicing physical activity.
This proposed study aims to demonstrate the beneficial effect of physical exercises coached with a specific internet program diffused on a secured platform.
Each patient will have to connect 3 times weekly in order to follow the entire program.
The impact will be evaluated at 3 months and 6 months.
Potential impacts of video-coaching program are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group: video coaching exercises | Experimental | Video coaching exercises group: patients will perform physical exercises according to a video coaching program 3 times weekly during 6 months. The on-line program has been designed especially for this study. |
|
| Control group: routine exercises | Active Comparator | Routine method advising and encouraging patients to perform physical activities according to the WHO recommendations during 3 months then to follow the video coaching physical exercises program during 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video coaching exercises | Other | Patients will perform physical exercises following a specifical video coaching program during 6 months. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Ankylosing Spondylitis Disease Activity : (ASDAS CRP) (PRO) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick Le Goux, MD | Contact | + 33 1 49 09 56 84 | patrick.legoux@aphp.fr | |
| Gilles Hayem, MD | Contact | + 33 1 49 09 53 07 | ghayem@hpsj.fr |
| Name | Affiliation | Role |
|---|---|---|
| Patrick Le Goux, MD | Service de rhumatologie, Hôpital Ambroise Paré | Principal Investigator |
| Gilles Hayem, MD | Service de rhumatologie, Hôpital Saint Joseph, 185 Rue Raymond Losserand 75014 Paris | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de rhumatologie, Hôpital Ambroise Paré | Recruiting | Boulogne-Billancourt | Hauts-de-Seine | 92100 | France |
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| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
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| Routine exercises | Other | Routine method by advising and encouraging patients to perform exercises according to the WHO recommendations during the first 3 months of the study. Thereafter, patients will have access to the video coaching program of physical activities during the following 3 months. |
|
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 |
| 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 |
| Fatigue (PRO) | Fatigue will be assessed with a Visual Analogue Scale | at baseline, 3 months and 6 months |
| 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 |
| 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 |
| 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 |
| Sleep quality: PSQI | Sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI) auto-questionnaire | at baseline, 3 months and 6 months |
| 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 |
| Analgesic and anti-inflammatory drug intake | Following drugs intake will be collected:
| at 3 months and 6 months |
| 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 |
| Anthropometric measures: Enthesitis: MASES | Entesis involvement will be assessed with the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) | at baseline, 3 months and 6 months |
| 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 |
| Anthropometric measures: 6-minutes walk test | Walking ability will be assessed with the 6-minutes walking test. | at baseline, 3 months and 6 months |
| 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 |
| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
| D001519 | Behavior |