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

NCT07034404 | Not Yet Recruiting DMC

• 1 other identifier: EssaiClinique_ASPIRE
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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

Keywords

exercise; physical activity; sleep quality; digital intervention

Outcome Measures

Primary Outcomes (2)

• Change from Baseline in Steps Per Day at 6 months

  Measured by Actigraph GT3X

  Baseline and 6 months

• Change from Baseline in Sleep Quality at 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).

  Baseline and 6 months

Secondary Outcomes (23)

• Change in Steps Per Day from Baseline at 12 months

  Baseline and 12 months

• Change in Sleep Quality from Baseline at 12 months

  Baseline and 12 months

• Change from Baseline in Total Sleep Time at 6 and 12 months

  Baseline, 6 months and 12 months

• Change from Baseline in Time Spent in Physical Activity at 6 and 12 months

  Baseline, 6 months and 12 months

• Change from Baseline in Time Spent in Sedentary Behavior at 6 and 12 months

  Baseline, 6 months and 12 months

Study Arms (2)

Control

ACTIVE COMPARATOR

Behavioral: Control (Standard treatment)

Digital Adapted Physical Activity

EXPERIMENTAL

Behavioral: Digital Adapted Physical Activity

Interventions

Digital Adapted Physical Activity 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.

Digital Adapted Physical Activity

Control (Standard treatment) 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.

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 to 80
• Followed in rheumatology for axial spondyloarthritis validating the ASAS or modified New York criteria at all stages of progression,
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (3)

CHU de Bordeaux

Bordeaux, France

Location

CHU Clermont Ferrand

Clermont-Ferrand, France

Location

CHU Saint Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

Spondylarthritis; Spondylarthropathies; Spondylitis; Motor Activity; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Bone Diseases, Infectious; Infections; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Athan Baillet Professor, MD PhD

CONTACT

+33-0476768082; AccueilRecherche@chu-grenoble.Fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 24, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: June 29, 2025

Record last verified: 2025-06

Locations

FR (3)