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Clinical Trials in France / NCT07034404
Starting soon Not applicable

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

NCT07034404 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Grenoble
Phase
Not applicable
Started
2025-07-01
Last updated
2025-06-29

Condition(s) studied

SpondylarthritisSpondylarthropathies; Spondylitis, Ankylosing

Investigational drug(s) / intervention(s)

Digital Adapted Physical ActivityControl (Standard treatment)

Digital Adapted Physical Activity: The 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): Participants 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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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 mass index \>35 kg/m2 * History of chest pain during physical activity * History of sudden death in a first-degree relative * History of thoracic irradiation

Primary outcome measure(s)

  • Change from Baseline in Steps Per Day at 6 months — Baseline and 6 months
    Measured by Actigraph GT3X
  • Change from Baseline in Sleep Quality at 6 months — Baseline and 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).

Trial sites (3)

FacilityCityRegionStatus
CHU de Bordeaux Bordeaux France
CHU Clermont Ferrand Clermont-Ferrand France
CHU Saint Etienne Saint-Etienne France

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07034404 on ClinicalTrials.gov ↗ ← All trials in France