An interventional study of Digital Adapted Physical Activity and Control (Standard treatment) in Spondylarthritis and Spondylarthropathies; Spondylitis, Ankylosing, sponsored by University Hospital, Grenoble. Not yet recruiting at 3 sites in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-06-29.
Sponsored by University Hospital, Grenoble · Not applicable, Interventional, and Supportive care
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.
68 studies on the registry are indexed under Spondylarthropathies; 10 are open to participants now.
This study's planned enrollment of 100 is close to the median of 103 across 40 interventional studies indexed under Spondylarthropathies.
Browse Spondylarthropathies studies →University Hospital, Grenoble is the lead sponsor of 837 studies on the registry; 207 are open to participants now.
Compared within Spondylarthropathies, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Spondylarthritis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Non-inclusion criteria related to physical activity :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Control (Standard treatment)
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.
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.
Change from Baseline in Steps Per Day at 6 months
Measured by Actigraph GT3X
Time frame: 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).
Time frame: Baseline and 6 months
Change in Steps Per Day from Baseline at 12 months
Measured by Actigraph (GT3X)
Time frame: Baseline and 12 months
Change in Sleep Quality from Baseline at 12 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).
Time frame: Baseline and 12 months
Change from Baseline in Total Sleep Time at 6 and 12 months
Measured using wrist-worn actigraphy (Actigraph GT3X)
Time frame: Baseline, 6 months and 12 months
Change from Baseline in Time Spent in Physical Activity at 6 and 12 months
Measured by time spent in light, moderate and sustained physical activity
Time frame: Baseline, 6 months and 12 months
Change from Baseline in Time Spent in Sedentary Behavior at 6 and 12 months
Measured by time spent awake in a seated or lying position measured by actimeter (Actigraph GT3X)
Time frame: Baseline, 6 months and 12 months
Change from Baseline in Sleep Quality at 6 and 12 months
Measured using wrist-worn actigraphy (Actigraph GT3X)
Time frame: Baseline, 6 months and 12 months
Change from Baseline in Fatigue at 6 and 12 months
Measured by the Pichot fatigue scale / Likert scale / This scale includes 8 items scored from 0 (strongly disagree) to 4 (strongly agree), with a total score ranging from 0 (no fatigue) to 32 (maximum fatigue)
Time frame: Baseline, 6 months and 12 months
Change from Baseline in Pain at 6 and 12 months
Measured by the visual analogue scale / Visual Analog Scale (VAS) / This scale consists of 1 item scored from 0 (no pain) to 10 (extreme pain)
Time frame: Baseline, 6 months and 12 months
Change from baseline in Disease Activity BASDAI to 6 and 12 months
Measured using questionnaires Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) / Self-administered scale / This scale consists of 6 items assessed on a numerical rating scale from 0 (not at all) to 10 (extremely). The overall score is the average of the six responses, giving a total score between 0 (no symptoms) and 10 (maximum symptoms).
Time frame: Baseline, 6 months and 12 months
Change from Baseline in Disease Activity ASDAS at 6 and 12 months
Measured using questionnaires Ankylosing Spondylitis Disease Activity Score (ASDAS) / A composite index combining several clinical variables and a biological marker of inflammation. The final score is calculated using a weighted formula, resulting in a continuous score / ASDAS values generally range from 0 to over 6, with the following thresholds: * \< 1.3: Inactive disease * 1.3 to \< 2.1: Moderate disease activity * 2.1 to \< 3.5: High disease activity * ≥ 3.5: Very high disease activity
Time frame: Baseline, 6 months and 12 months
Change from Baseline in Functional Capacity at 6 and 12 months
Measured using questionnaires an Bath Ankylosing Spondylitis Functional Index (BASFI) / Self-administered questionnaire / This questionnaire consists of 10 items. Each item is scored on a numerical rating scale from 0 (no difficulty) to 10 (impossible). The final score is the average of the 10 responses, giving a total score between 0 (optimal functioning) and 10 (severely impaired functioning).
Time frame: Baseline, 6 months and 12 months
Change from Baseline in Quality of life ASAS-HI at 6 and 12 months
Measured using questionnaire ASAS-HI (Assessment of SpondyloArthritis International Society Health Index) / Likert-type scale / A questionnaire composed of 17 items. Each item is scored in a binary way (Agree = 1, Disagree = 0). The total score therefore ranges from 0 (best possible health) to 17 (significant health impairment).
Time frame: Baseline, 6 months and 12 months
Change from Baseline in Health-Related Quality of life at 6 and 12 months
Health-related quality of life (EQ-5D-5L) / 2 parts: * A descriptive system with 5 dimensions, each rated on 5 levels of severity (from 1 = no problems to 5 = extreme problems). The combination of responses defines a health state that can be converted into a single index value, generally ranging from -0.594 to 1, where 1 represents perfect health, 0 is equivalent to death, and negative values indicate a health state perceived as worse than death. * A visual analog scale ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine).
Time frame: Baseline, 6 months and 12 months
Change from Baseline in Cardiorespiratory fitness (VO2peak) at 6 months
Cardiorespiratory stress test
Time frame: Baseline, 6 months
Change from Baseline in Maximal Power Output at 6 months
Maximal Power Output (watts)
Time frame: Baseline, 6 months
Change from Baseline in Barriers and Facilitators to Physical Activity at 3, 6 and 12 months
Measured using questionnaire Inflammatory Arthritis Facilitators and Barriers (IFAB) / A questionnaire consisting of 10 items / Elements that can be either barriers or facilitators are scored from -10 to 10. Items that are only barriers are scored from -10 to 0, and those that are only facilitators are scored from 0 to 10. When an item has no impact on physical activity, it is scored 0. If a question is missing, the item is scored 0. If two or more questions are missing, it is recommended not to compute the total score. The total score ranges from -70 to 70. Scores below -5 may justify targeted intervention.
Time frame: Baseline, 3 months, 6 months and 12 months
Change from Baseline in Motivation for Physical Activity at 3, 6 and 12 months
Measured using questionnaire motivational scale for physical activity for health purposes (EMAPS) / Questionnaire based on the self-determination theory / Composed of 18 items. Each item is scored on a 7-point Likert scale from 1 (does not correspond at all) to 7 (corresponds very strongly). Mean scores are calculated for each subscale / The questionnaire represents the following types of motivation: * Intrinsic motivation * Integrated motivation * Identified motivation * Introjected motivation * External motivation * Amotivation
Time frame: Baseline, 3 months, 6 months and 12 months
Change from Baseline in Self-Esteem at 3, 6 and 12 months
Measured using questionnaire Rosenberg scale / A self-assessment questionnaire composed of 10 items / Each item is rated on a 4-point Likert scale from 1 (strongly disagree) to 4 (strongly agree). The total score ranges from 10 to 40, with some items reverse-scored.
Time frame: Baseline, 3 months, 6 months and 12 months
Change from Baseline in Pain Catastrophizing at 3, 6, 12 months
Pain Castrophizing Scale / A self-administered questionnaire / It includes 13 items divided into 3 dimensions: * Rumination * Magnification * Helplessness / Each item is rated on a Likert scale from 0 (not at all) to 4 (all the time). The total score ranges from 0 to 52, with subscores for each dimension
Time frame: Baseline, 3, 6, 12 months
Adherence to the Adapted Physical Activity Intervention
Percentage of Physical Activity Sessions Completed by the Participant
Time frame: At 6 months
Identify profiles of participants who are adherent or non- adherent to the Physical Activity Intervention according to personal determinants (motivation, beliefs)
Adherent or non-adherent (adherence status defined as \< 50% sessions completed)
Time frame: At 6 months
Determine Sleep Quality Trajectories
Determine sleep quality trajectories based on data collected by the connected device (Sleel Analyzer, Withings) in the intervention group only
Time frame: Over 12 months
Intervention Satisfaction and Acceptability
Perceived acceptability and satisfaction measured using a questionnaire in the intervention group
Time frame: At 6 months
Start is estimated for Jul 2025; primary completion for Mar 2028, 32 months later.
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This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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