Набор скоро начнётся NCT07034404

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

Без фазы С лечением Spondylarthritis Spondylarthropathies; Spondylitis, Ankylosing

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Digital Adapted Physical Activity, Control (Standard treatment).
Кому может быть актуально: Состояния в реестре: Spondylarthritis, Spondylarthropathies; Spondylitis, Ankylosing. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

Поведенческое 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
Поведенческое 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.

Первичные конечные точки

Change from Baseline in Steps Per Day at 6 months [Срок оценки: Baseline and 6 months]
Change from Baseline in Sleep Quality at 6 months [Срок оценки: Baseline and 6 months]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

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)

Критерии исключения

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 :