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

NCT ID: NCT07034404

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2028-09-30

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.

Conditions

Spondylarthritis; Spondylarthropathies; Spondylitis, Ankylosing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control

Group Type: ACTIVE_COMPARATOR

Control (Standard treatment)

Intervention Type: BEHAVIORAL

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.

Digital Adapted Physical Activity

Group Type: EXPERIMENTAL

Digital Adapted Physical Activity

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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)

• 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Bordeaux

Bordeaux, , France

CHU Clermont Ferrand

Clermont-Ferrand, , France

CHU Saint Etienne

Saint-Etienne, , France

Countries

France

Central Contacts

Athan Baillet Professor, MD PhD

Role: CONTACT

AccueilRecherche@chu-grenoble.Fr

+33-0476768082

Facility Contacts

Thierry Schaeverbeke Professor, MD PhD

Role: primary

AccueilRecherche@chu-bordeaux.fr

33-5 56 79 55 45

Anne Tournadre Professor, MD PhD

Role: primary

AccueilRecherche@chu-clermontferrand.fr

33-4 73 75 07 50

Hubert Marotte Professor, MD PhD

Role: primary

AccueilRecherche@chu-st-etienne.fr

33-04 77 82 80 00

Other Identifiers

EssaiClinique_ASPIRE

Identifier Type: -

Identifier Source: org_study_id