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

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.

Overview

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.

Interventions

• Behavioral 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
• Behavioral 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.

Primary outcome measures

• Change from Baseline in Steps Per Day at 6 months [Time frame: Baseline and 6 months]
• Change from Baseline in Sleep Quality at 6 months [Time frame: Baseline and 6 months]

Secondary outcome measures (12)

• Change in Steps Per Day from Baseline at 12 months [Time frame: Baseline and 12 months]
• Change in Sleep Quality from Baseline at 12 months [Time frame: Baseline and 12 months]
• Change from Baseline in Total Sleep Time at 6 and 12 months [Time frame: Baseline, 6 months and 12 months]
• Change from Baseline in Time Spent in Physical Activity at 6 and 12 months [Time frame: Baseline, 6 months and 12 months]
• Change from Baseline in Time Spent in Sedentary Behavior at 6 and 12 months [Time frame: Baseline, 6 months and 12 months]
• Change from Baseline in Sleep Quality at 6 and 12 months [Time frame: Baseline, 6 months and 12 months]
• Change from Baseline in Fatigue at 6 and 12 months [Time frame: Baseline, 6 months and 12 months]
• Change from Baseline in Pain at 6 and 12 months [Time frame: Baseline, 6 months and 12 months]
• Change from baseline in Disease Activity BASDAI to 6 and 12 months [Time frame: Baseline, 6 months and 12 months]
• Change from Baseline in Disease Activity ASDAS at 6 and 12 months [Time frame: Baseline, 6 months and 12 months]
• Change from Baseline in Functional Capacity at 6 and 12 months [Time frame: Baseline, 6 months and 12 months]
• Change from Baseline in Quality of life ASAS-HI at 6 and 12 months [Time frame: Baseline, 6 months and 12 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

France · 3 centers

• CHU de Bordeaux — Bordeaux
• CHU Clermont Ferrand — Clermont-Ferrand
• CHU Saint Etienne — Saint-Etienne

Identifiers

NCT: NCT07034404 · EssaiClinique_ASPIRE

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗