Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-01-01 @ 9:24 PM
Study NCT ID:
NCT07034404
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-29
First Post:
2025-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a Digital Exercise Intervention on Sleep and Physical Activity in Patients With Spondyloarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D001850', 'term': 'Bone Diseases, Infectious'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-25', 'studyFirstSubmitDate': '2025-06-13', 'studyFirstSubmitQcDate': '2025-06-13', 'lastUpdatePostDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Steps Per Day at 6 months', 'timeFrame': 'Baseline and 6 months', 'description': 'Measured by Actigraph GT3X'}, {'measure': 'Change from Baseline in Sleep Quality at 6 months', 'timeFrame': 'Baseline and 6 months', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Change in Steps Per Day from Baseline at 12 months', 'timeFrame': 'Baseline and 12 months', 'description': 'Measured by Actigraph (GT3X)'}, {'measure': 'Change in Sleep Quality from Baseline at 12 months', 'timeFrame': 'Baseline and 12 months', 'description': '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).'}, {'measure': 'Change from Baseline in Total Sleep Time at 6 and 12 months', 'timeFrame': 'Baseline, 6 months and 12 months', 'description': 'Measured using wrist-worn actigraphy (Actigraph GT3X)'}, {'measure': 'Change from Baseline in Time Spent in Physical Activity at 6 and 12 months', 'timeFrame': 'Baseline, 6 months and 12 months', 'description': 'Measured by time spent in light, moderate and sustained physical activity'}, {'measure': 'Change from Baseline in Time Spent in Sedentary Behavior at 6 and 12 months', 'timeFrame': 'Baseline, 6 months and 12 months', 'description': 'Measured by time spent awake in a seated or lying position measured by actimeter (Actigraph GT3X)'}, {'measure': 'Change from Baseline in Sleep Quality at 6 and 12 months', 'timeFrame': 'Baseline, 6 months and 12 months', 'description': 'Measured using wrist-worn actigraphy (Actigraph GT3X)'}, {'measure': 'Change from Baseline in Fatigue at 6 and 12 months', 'timeFrame': 'Baseline, 6 months and 12 months', 'description': '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)'}, {'measure': 'Change from Baseline in Pain at 6 and 12 months', 'timeFrame': 'Baseline, 6 months and 12 months', 'description': '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)'}, {'measure': 'Change from baseline in Disease Activity BASDAI to 6 and 12 months', 'timeFrame': 'Baseline, 6 months and 12 months', 'description': '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).'}, {'measure': 'Change from Baseline in Disease Activity ASDAS at 6 and 12 months', 'timeFrame': 'Baseline, 6 months and 12 months', 'description': '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:\n\n* \\< 1.3: Inactive disease\n* 1.3 to \\< 2.1: Moderate disease activity\n* 2.1 to \\< 3.5: High disease activity\n* ≥ 3.5: Very high disease activity'}, {'measure': 'Change from Baseline in Functional Capacity at 6 and 12 months', 'timeFrame': 'Baseline, 6 months and 12 months', 'description': '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).'}, {'measure': 'Change from Baseline in Quality of life ASAS-HI at 6 and 12 months', 'timeFrame': 'Baseline, 6 months and 12 months', 'description': '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).'}, {'measure': 'Change from Baseline in Health-Related Quality of life at 6 and 12 months', 'timeFrame': 'Baseline, 6 months and 12 months', 'description': 'Health-related quality of life (EQ-5D-5L) / 2 parts:\n\n* 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.\n* A visual analog scale ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine).'}, {'measure': 'Change from Baseline in Cardiorespiratory fitness (VO2peak) at 6 months', 'timeFrame': 'Baseline, 6 months', 'description': 'Cardiorespiratory stress test'}, {'measure': 'Change from Baseline in Maximal Power Output at 6 months', 'timeFrame': 'Baseline, 6 months', 'description': 'Maximal Power Output (watts)'}, {'measure': 'Change from Baseline in Barriers and Facilitators to Physical Activity at 3, 6 and 12 months', 'timeFrame': 'Baseline, 3 months, 6 months and 12 months', 'description': '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.'}, {'measure': 'Change from Baseline in Motivation for Physical Activity at 3, 6 and 12 months', 'timeFrame': 'Baseline, 3 months, 6 months and 12 months', 'description': '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:\n\n* Intrinsic motivation\n* Integrated motivation\n* Identified motivation\n* Introjected motivation\n* External motivation\n* Amotivation'}, {'measure': 'Change from Baseline in Self-Esteem at 3, 6 and 12 months', 'timeFrame': 'Baseline, 3 months, 6 months and 12 months', 'description': '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.'}, {'measure': 'Change from Baseline in Pain Catastrophizing at 3, 6, 12 months', 'timeFrame': 'Baseline, 3, 6, 12 months', 'description': 'Pain Castrophizing Scale / A self-administered questionnaire / It includes 13 items divided into 3 dimensions:\n\n* Rumination\n* Magnification\n* 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'}, {'measure': 'Adherence to the Adapted Physical Activity Intervention', 'timeFrame': 'At 6 months', 'description': 'Percentage of Physical Activity Sessions Completed by the Participant'}, {'measure': 'Identify profiles of participants who are adherent or non- adherent to the Physical Activity Intervention according to personal determinants (motivation, beliefs)', 'timeFrame': 'At 6 months', 'description': 'Adherent or non-adherent (adherence status defined as \\< 50% sessions completed)'}, {'measure': 'Determine Sleep Quality Trajectories', 'timeFrame': 'Over 12 months', 'description': 'Determine sleep quality trajectories based on data collected by the connected device (Sleel Analyzer, Withings) in the intervention group only'}, {'measure': 'Intervention Satisfaction and Acceptability', 'timeFrame': 'At 6 months', 'description': 'Perceived acceptability and satisfaction measured using a questionnaire in the intervention group'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['exercise', 'physical activity', 'sleep quality', 'digital intervention'], 'conditions': ['Spondylarthritis', 'Spondylarthropathies; Spondylitis, Ankylosing']}, 'descriptionModule': {'briefSummary': '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).\n\nThe main questions it aims to answer are:\n\nDoes 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.\n\nParticipants will:\n\nComplete baseline assessments including physical activity, sleep, pain, and quality of life measures.\n\nBe 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.\n\nWear a connected activity tracker (Withings) to monitor physical activity throughout the study.\n\nComplete follow-up assessments at 6 and 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 to 80\n* Followed in rheumatology for axial spondyloarthritis validating the ASAS or modified New York criteria at all stages of progression,\n* 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).\n* With stable treatment for 3 months\n* Signed informed consent\n* Membership of a social security scheme\n* Have access to a digital tool with an internet connection (tablet or smartphone)\n\nExclusion Criteria:\n\n* Concurrent impairment by another osteoarticular pathology interfering with mobility of the spine or lower limbs,\n* Central or peripheral neurological damage,\n* Hip, knee or ankle arthroplasty performed or scheduled within 18 months,\n* 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.).\n* Patients who do more than 150 minutes of moderate-intensity vigorous physical activity per week as part of their leisure activities.\n* Persons covered by articles L1121-5 to L1121-8 of the Public Health Code\n* Staff with a hierarchical link to the principal investigator\n\nNon-inclusion criteria related to physical activity :\n\n* Body mass index \\>35 kg/m2\n* History of chest pain during physical activity\n* History of sudden death in a first-degree relative\n* History of thoracic irradiation'}, 'identificationModule': {'nctId': 'NCT07034404', 'acronym': 'ASPIRE', 'briefTitle': 'Effects of a Digital Exercise Intervention on Sleep and Physical Activity in Patients With Spondyloarthritis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Effects of a Digital Adapted Physical Activity Program on Physical Activity Levels and Sleep Quality in Patients With Spondyloarthritis: A Randomized, Controlled, Multicenter Study.', 'orgStudyIdInfo': {'id': 'EssaiClinique_ASPIRE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'interventionNames': ['Behavioral: Control (Standard treatment)']}, {'type': 'EXPERIMENTAL', 'label': 'Digital Adapted Physical Activity', 'interventionNames': ['Behavioral: Digital Adapted Physical Activity']}], 'interventions': [{'name': 'Digital Adapted Physical Activity', 'type': 'BEHAVIORAL', 'description': '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).\n\nParticipants 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.', 'armGroupLabels': ['Digital Adapted Physical Activity']}, {'name': 'Control (Standard treatment)', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bordeaux', 'country': 'France', 'contacts': [{'name': 'Thierry Schaeverbeke Professor, MD PhD', 'role': 'CONTACT', 'email': 'AccueilRecherche@chu-bordeaux.fr', 'phone': '33-5 56 79 55 45'}], 'facility': 'CHU de Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Clermont-Ferrand', 'country': 'France', 'contacts': [{'name': 'Anne Tournadre Professor, MD PhD', 'role': 'CONTACT', 'email': 'AccueilRecherche@chu-clermontferrand.fr', 'phone': '33-4 73 75 07 50'}], 'facility': 'CHU Clermont Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Saint-Etienne', 'country': 'France', 'contacts': [{'name': 'Hubert Marotte Professor, MD PhD', 'role': 'CONTACT', 'email': 'AccueilRecherche@chu-st-etienne.fr', 'phone': '33-04 77 82 80 00'}], 'facility': 'CHU Saint Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'centralContacts': [{'name': 'Athan Baillet Professor, MD PhD', 'role': 'CONTACT', 'email': 'AccueilRecherche@chu-grenoble.Fr', 'phone': '+33-0476768082'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}