Axial SpondyloarthritisSatiSpActionNCT03965650
Video Coaching of Physical Activity in Axial Spondyloarthritis
A study testing Video coaching exercises and Routine exercises in people with Axial Spondyloarthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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 : 1. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Axial Spondyloarthritis
- What is being tested?
- Video coaching exercises and Routine exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 24 Feb 2022to 13 Aug 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Service de rhumatologie, Hôpital Ambroise Paré
Boulogne-Billancourt, Hauts-de-Seine, 92100
About this study
Official 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 :
- 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.
- to evaluate the observance of physical activity program and its tolerance at 3 and 6 months.
Read the 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:
- reduction of the intrinsic inflammatory activity of the rheumatic disease;
- improvement of the global physical condition: muscular strength and resistance, walking ability, chest expansion;
- reduction of fatigue and improvement of sleeping;
- reduction of consumption of symptomatic drug (analgesics, NSAIDs, corticosteroids).
- Conditions
- Axial Spondyloarthritis
- Being tested
- Video coaching exercises, Routine exercises
- Keywords
- axial spondyloarthritis, online video coaching, physical activity
- Medical subject headings
- Axial Spondyloarthritis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video coaching exercisesOther
Patients will perform physical exercises following a specifical video coaching program during 6 months.
Routine exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Video coaching exercises |
| 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. Receives: Other: Routine exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: at 3 months
Secondary outcomes (15)
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.
Measured: at baseline, 3 months and 6 months
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.
Measured: 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.
Measured: at baseline, 3 months and 6 months
Fatigue (PRO)
Fatigue will be assessed with a Visual Analogue Scale
Measured: 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)
Measured: 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
Measured: 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
Measured: at baseline, 3 months and 6 months
Sleep quality: PSQI
Sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI) auto-questionnaire
Measured: 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
Measured: at baseline, 3 months and 6 months
Analgesic and anti-inflammatory drug intake
Following drugs intake will be collected:
- non-steroidal anti-inflammatory drugs (NSAIDs)
- corticosteroids
Measured: 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)
Measured: at baseline, 3 months and 6 months
Anthropometric measures: Enthesitis: MASES
Entesis involvement will be assessed with the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
Measured: 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
Measured: at baseline, 3 months and 6 months
Anthropometric measures: 6-minutes walk test
Walking ability will be assessed with the 6-minutes walking test.
Measured: 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.
Measured: at baseline, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start24 Feb 2022
- Primary completion13 Aug 2026 (estimated)
- Study completion13 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Le Goux, MD, Principal investigator, Service de rhumatologie, Hôpital Ambroise ParéGilles Hayem, MD, Study director, Service de rhumatologie, Hôpital Saint Joseph, 185 Rue Raymond Losserand 75014 Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965650
- Sponsor's protocol ID
- APHP190622
- Other IDs
- 2019-A01384-53
- Acronym
- SatiSpAction
- Status last verified
- Jul 2026
- First submitted
- 24 May 2019
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No