Video Coaching of Physical Activity in Axial Spondyloarthritis (NCT03965650) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Video Coaching of Physical Activity in Axial Spondyloarthritis
France60 participantsStarted 2022-02-24
Plain-language 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. 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients responding to the "ASAS 20" criterion at 3 months