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:
Condition or disease | Intervention/treatment | Phase |
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Axial Spondyloarthritis | Other: Video coaching exercises Other: Routine exercises | Not Applicable |
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:
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Randomized Controlled Study of a Video Coaching Program of Physical Activity in Patients Suffering From Axial Spondyloarthritis |
Estimated Study Start Date : | May 2021 |
Estimated Primary Completion Date : | June 2021 |
Estimated Study Completion Date : | June 2021 |
Arm | Intervention/treatment |
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Experimental: Intervention group: video coaching exercises
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.
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Other: Video coaching exercises
Patients will perform physical exercises following a specifical video coaching program during 6 months.
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Active Comparator: Control group: routine exercises
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.
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Other: Routine exercises
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. |
The primary outcome measure will be the proportion of patients simultaneously satisfying both criteria :
Following drugs intake will be collected:
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Patrick Le Goux, MD | + 33 1 49 09 56 84 | patrick.legoux@aphp.fr | |
Contact: Gilles Hayem, MD | + 33 1 49 09 53 07 | gilles.hayem@aphp.fr |
France | |
Service de rhumatologie, Hôpital Ambroise Paré | |
Boulogne-Billancourt, Hauts-de-Seine, France, 92100 | |
Contact: Patrick Le Goux, MD + 33 1 49 09 56 84 patrick.legoux@aphp.fr | |
Contact: Gilles Hayem, MD + 33 1 49 09 53 07 gilles.hayem@aphp.fr |
Principal Investigator: | Patrick Le Goux, MD | Service de rhumatologie, Hôpital Ambroise Paré | |
Study Director: | Gilles Hayem, MD | Service de rhumatologie, Hôpital Ambroise Paré |
Tracking Information | |||||||||
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First Submitted Date ICMJE | May 24, 2019 | ||||||||
First Posted Date ICMJE | May 29, 2019 | ||||||||
Last Update Posted Date | February 25, 2021 | ||||||||
Estimated Study Start Date ICMJE | May 2021 | ||||||||
Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Proportion of patients responding to the "ASAS 20" criterion at 3 months [ Time Frame: at 3 months ] The primary outcome measure will be the proportion of patients simultaneously satisfying both criteria :
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Video Coaching of Physical Activity in Axial Spondyloarthritis | ||||||||
Official Title ICMJE | Randomized Controlled Study of a Video Coaching Program of Physical Activity in Patients Suffering From Axial Spondyloarthritis | ||||||||
Brief Summary |
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 :
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Detailed Description |
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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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Axial Spondyloarthritis | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||||
Estimated Enrollment ICMJE |
60 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | June 2021 | ||||||||
Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | France | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03965650 | ||||||||
Other Study ID Numbers ICMJE | 17PLX-SATISPACTION | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Assistance Publique - Hôpitaux de Paris | ||||||||
Study Sponsor ICMJE | Assistance Publique - Hôpitaux de Paris | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Assistance Publique - Hôpitaux de Paris | ||||||||
Verification Date | February 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |