MedTrace Logo

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

NCT07034404 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-06-29

No results posted yet for this study

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

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 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.

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.

Sponsors & Collaborators

  • University Hospital, Grenoble

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2028-03-31
Completion
2028-09-30

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07034404 on ClinicalTrials.gov