The goal of this clinical trial is to assess whether a tailored digital Adapted Physical Activity (APA) program can improve physical activity levels and sleep quality in adults diagnosed with spondyloarthritis (SpA).
The main questions it aims to answer are:
Does participation in a 6-month digital APA program increase average daily step count (measured with an activity tracker)? Does the program improve sleep quality (measured with the Pittsburgh Sleep Quality Index)? Researchers will compare participants receiving general physical activity advice (control group) to those following a structured digital APA program (intervention group) to see if the tailored digital support leads to better outcomes.
Participants will:
Complete baseline assessments including physical activity, sleep, pain, and quality of life measures.
Be randomly assigned to a control group or intervention group. For the intervention group, follow an individualized exercise program delivered through a virtual platform with support from an APA professional over 10 virtual sessions.
Wear a connected activity tracker (Withings) to monitor physical activity throughout the study.
Complete follow-up assessments at 6 and 12 months.
Adults aged 18 to 80
Followed in rheumatology for axial spondyloarthritis validating the ASAS or modified New York criteria at all stages of progression,
Physically inactive (less than 150 minutes of moderate-intensity leisure-time physical activity per week), assessed at inclusion using the Global Physical Activity Questionnaire (GPAQ).
With stable treatment for 3 months
Concurrent impairment by another osteoarticular pathology interfering with mobility of the spine or lower limbs,
Central or peripheral neurological damage,
Hip, knee or ankle arthroplasty performed or scheduled within 18 months,
Any contraindication to physical activity (unstable or poorly controlled coronary ischaemia, severe asthma or significant obstructive ventilatory disorder (FEV1/FVC < 70%, FEV1 < 60% predicted), musculoskeletal pathology interfering with physical activity, proliferative retinopathy, macroscopic proteinuria, poorly controlled hypertension, etc.).
Parallel
Digital Adapted Physical Activity
BehavioralThe digital Adapted Physical Activity (APA) program will be delivered via a digital platform and participants will be guided by an APA teacher to meet the WHO recommendations (i.e. 150 minutes of moderate intensity aerobic PA per week and muscle-strengthening activities that involve all major muscle groups twice weekly). Participants will benefit from 10 visits with the APA teacher: an initial assessment to define personalized goals and familiarize participants with the digital platform, eight sessions to monitor progress and adapt the exercise program, and a final evaluation aimed at assessing outcomes and encouraging long-term adherence to physical activity. Daily physical activity will be objectively monitored using a Withings connected watch to provide feedback and track metrics such as step count.
Control (Standard treatment)
BehavioralParticipants will receive standard care and advice on physical activity (based on the recommendations of the World Health Organization, WHO, and the European Alliance of Associations for Rheumatology, EULAR) through a document provided to them.
Change from Baseline in Steps Per Day at 6 months
Measured by Actigraph GT3X
Change from Baseline in Sleep Quality at 6 months
Measured by the Pittsburgh Sleep Quality Index (PSQI) / A self-administered questionnaire / The 19 self-evaluation questions combine to yield 7 component scores, each scored from 0 to 3. A score of 0 indicates no difficulty, while a score of 3 indicates severe difficulty. The 7 component scores are summed to obtain a global score ranging from 0 (no difficulty) to 21 (major difficulties).
Change in Steps Per Day from Baseline at 12 months
Measured by Actigraph (GT3X)
Change in Sleep Quality from Baseline at 12 months
Measured by the Pittsburgh Sleep Quality Index (PSQI) / A self-administered questionnaire / The 19 self-evaluation questions combine to yield 7 component scores, each scored from 0 to 3. A score of 0 indicates no difficulty, while a score of 3 indicates severe difficulty. The 7 component scores are summed to obtain a global score ranging from 0 (no difficulty) to 21 (major difficulties).
Change from Baseline in Total Sleep Time at 6 and 12 months
Measured using wrist-worn actigraphy (Actigraph GT3X)
Change from Baseline in Time Spent in Physical Activity at 6 and 12 months
Measured by time spent in light, moderate and sustained physical activity
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