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ClinicalTrials.gov ID

NCT07034404

Lead Sponsor

University Hospital, GrenobleOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

100Estimated

Last Update Posted

Jun 29, 2025Actual

Start Date

Jul 1, 2025Estimated

Primary Completion Date

Mar 2028Estimated

Completion Date

Sep 2028Estimated

Official Title

Effects of a Digital Adapted Physical Activity Program on Physical Activity Levels and Sleep Quality in Patients With Spondyloarthritis: A Randomized, Controlled, Multicenter Study.

Brief 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.

• Spondylarthritis
• Spondylarthropathies; Spondylitis, Ankylosing

• Digital Adapted Physical Activity
• Control (Standard treatment)

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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 Purpose

Supportive Care

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

University Hospital, GrenobleOTHER

AccueilRecherche@chu-clermontferrand.fr33-4 73 75 07 50

AccueilRecherche@chu-st-etienne.fr33-04 77 82 80 00