NCT07034404Not yet recruiting
Effects of a Digital Exercise Intervention on Sleep and Physical Activity in Patients With Spondyloarthritis
Effects of a Digital Adapted Physical Activity Program on Physical Activity Levels and Sleep Quality in Patients With Spondyloarthritis: A Randomized, Controlled, Multicenter Study.
Source: ClinicalTrials.gov · Last updated 29 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 13 Jun 2025
- Start date
- 1 Jul 2025
- Primary completion date
- 31 Mar 2028
- Lead sponsor
- University Hospital, Grenoble
- Diseases
- Ankylosing spondylitis
- NCT number
- NCT07034404
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 1 Jul 2025 to the primary completion date, 31 Mar 2028
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent impairment by another osteoarticular pathology interfering with mobility of the spine or lower limbs,
Other illness
- 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.).
- History of chest pain during physical activity
- History of sudden death in a first-degree relative
- History of thoracic irradiation
Other
- Central or peripheral neurological damage,
- Hip, knee or ankle arthroplasty performed or scheduled within 18 months,
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| CHU Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
| CHU Saint-Etienne Coordinator of this site? Confirm its status | Saint-Etienne | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.