Not Yet RecruitingNot Applicable

Effects of a Digital Exercise Intervention on Sleep and Physical Activity in Patients With Spondyloarthritis

France100 participantsStarted 2025-07-01

Plain-language summary

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.

Who can participate

Age range

18 Years – 80 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: * 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 * Signed informed consent * Membership of a social security scheme * Have access to a digital tool with an internet connection (tablet or smartphone) Exclusion Criteria: * 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.). * Patients who do more than 150 minutes of moderate-intensity vigorous physical activity per week as part of their leisure activities. * Persons covered by articles L1121-5 to L1121-8 of the Public Health Code * Staff with a hierarchical link to the principal investigator Non-inclusion criteria related to physical activity : * Body m…

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

Change from Baseline in Steps Per Day at 6 months

Timeframe: Baseline and 6 months

Change from Baseline in Sleep Quality at 6 months

Timeframe: Baseline and 6 months

Trial details

NCT IDNCT07034404

SponsorUniversity Hospital, Grenoble

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-03

Contact for this trial

Athan Baillet Professor, MD PhD

+33-0476768082 AccueilRecherche@chu-grenoble.Fr

View on ClinicalTrials.gov More Spondylarthritis trials