Ignite Creation Date:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2025-12-26 @ 4:04 PM
Study NCT ID:
NCT07191106
Status:
RECRUITING
Last Update Posted:
2025-09-24
First Post:
2025-07-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pilot Study Assessing the Feasibility and Impact of a Remote Adapted Physical Activity Program on Quality of Life in Patients With Inflammatory Bowel Disease (IBD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D003108', 'term': 'Colonic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Pilot, multicenter, before-and-after study designed to assess the feasibility and preliminary effectiveness of a remotely delivered Adapted Physical Activity (APA) intervention via a mobile application. This is a low-risk, minimal constraint interventional study involving human participants.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2025-07-21', 'studyFirstSubmitQcDate': '2025-09-22', 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact of a Remote Adapted Physical Activity Program Delivered via the MOOV+ Application on Quality of Life in Patients With Inflammatory Bowel Disease: A Pilot Before-and-After Study', 'timeFrame': 'From baseline (Month 0) to Month 3', 'description': 'Change in total Inflammatory Bowel Disease Questionnaire (IBDQ-32) score between baseline and the end of the program at Month 3 (M3)'}], 'secondaryOutcomes': [{'measure': 'evaluate the effect of the program on the different subdomains of health-related quality of life, including bowel symptoms, systemic symptoms, emotional function, and social function', 'timeFrame': 'From baseline (Month 0) to Month 3', 'description': 'Variation in the four IBDQ-32 subscale scores between baseline (Month 0) and the end of the program (Month 3)'}, {'measure': 'Assess the feasibility of the Remote Adapted Physical Activity Program', 'timeFrame': 'From baseline (Month 0) to Month 3', 'description': 'Variation of participation rate (number of enrolled patients / number of eligible patients)'}, {'measure': 'Assess the feasibility of the of the Remote Adapted Physical Activity Program', 'timeFrame': 'From baseline (Month 0) to Month 3', 'description': 'Adherence to the program measured by session attendance rate (sessions attended / sessions scheduled) and dropout rate (number and reasons for early withdrawal).'}, {'measure': 'impact of APA on psychological status', 'timeFrame': 'From baseline (Month 0) to Month 3', 'description': 'HADS score'}, {'measure': 'impact of APA on fatigue level', 'timeFrame': 'From baseline (Month 0) to Month 3', 'description': 'FACIT fatigue score'}, {'measure': "Impact of APA on IBD activity_ crohn's disease", 'timeFrame': 'From baseline (Month 0) to Month 3', 'description': 'variation of Harvey-Bradshaw Index (HBI)'}, {'measure': 'Impact of APA on IBD activity_ ulcerative colitis', 'timeFrame': 'From baseline (Month 0) to Month 3', 'description': 'variation of partial mayo score'}, {'measure': 'evaluation of Persistence of physical activity', 'timeFrame': 'From baseline (Month 0) to Month 3', 'description': 'International Physical Activity Questionnaire (IPAQ )'}, {'measure': 'Change in Biological Markers of Disease Activity (CRP and Fecal Calprotectin)', 'timeFrame': 'From baseline (Month 0) to Month 3', 'description': 'The impact of Adapted Physical Activity (APA) on biological disease activity will be assessed through changes in C-reactive protein (CRP) levels and fecal calprotectin concentrations'}, {'measure': 'Evaluation of satisfaction level assessed using a 5-point Likert scale.', 'timeFrame': 'month 3', 'description': 'Evaluation of Satisfaction with a Remote Adapted Physical Activity Program Delivered via MOOV+ (from "1:Very dissatisfied" to "5 : very satisfied")'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IBD, crohn, ulcerative colitis'], 'conditions': ['Inflammatory Bowel Disease (IBD)', 'Inflammatory Bowel Disease (Crohn&Amp;#39;s Disease and Ulcerative Colitis)']}, 'referencesModule': {'references': [{'pmid': '21560190', 'type': 'BACKGROUND', 'citation': 'Nahon S, Lahmek P, Saas C, Durance C, Olympie A, Lesgourgues B, Gendre JP. Socioeconomic and psychological factors associated with nonadherence to treatment in inflammatory bowel disease patients: results of the ISSEO survey. Inflamm Bowel Dis. 2011 Jun;17(6):1270-6. doi: 10.1002/ibd.21482. Epub 2010 Oct 25.'}, {'pmid': '39478988', 'type': 'BACKGROUND', 'citation': 'Sarter H, Cretin T, Savoye G, Fumery M, Leroyer A, Dauchet L, Paupard T, Coevoet H, Wils P, Richard N, Turck D, Ley D, Gower-Rousseau C; EPIMAD study Group. Incidence, prevalence and clinical presentation of inflammatory bowel diseases in Northern France: a 30-year population-based study. Lancet Reg Health Eur. 2024 Oct 18;47:101097. doi: 10.1016/j.lanepe.2024.101097. eCollection 2024 Dec.'}, {'pmid': '27914657', 'type': 'BACKGROUND', 'citation': 'Ungaro R, Mehandru S, Allen PB, Peyrin-Biroulet L, Colombel JF. Ulcerative colitis. Lancet. 2017 Apr 29;389(10080):1756-1770. doi: 10.1016/S0140-6736(16)32126-2. Epub 2016 Dec 1.'}, {'pmid': '27914655', 'type': 'BACKGROUND', 'citation': "Torres J, Mehandru S, Colombel JF, Peyrin-Biroulet L. Crohn's disease. Lancet. 2017 Apr 29;389(10080):1741-1755. doi: 10.1016/S0140-6736(16)31711-1. Epub 2016 Dec 1."}]}, 'descriptionModule': {'briefSummary': "Inflammatory Bowel Disease (IBD) is a chronic relapsing condition that affects the gastrointestinal tract and is increasingly diagnosed in adolescents and young adults. Although anti-TNFα therapies are effective in reducing disease activity and improving quality of life, they are frequently associated with side effects such as fatigue, weight gain, and joint pain, which may be mitigated by regular physical activity.\n\nEmerging evidence suggests that light to moderate physical activity may help reduce systemic and intestinal inflammation and improve IBD-related outcomes. However, access to structured physical activity programs remains limited, and personal or professional constraints may hinder participation.\n\nThis pilot study aims to assess the feasibility and impact of a remotely delivered Adapted Physical Activity (APA) program on the quality of life of patients with Inflammatory Bowel Disease (IBD), including Crohn's disease and ulcerative colitis. This study evaluates the effects of a 12-weeks remote APA intervention on quality of life as the primary outcome.\n\nSecondary objectives include assessing changes in anxiety and depression, fatigue levels, IBD activity, and smoking behavior. The findings from this study may inform the development of scalable, non-pharmacological strategies to support symptom management and well-being in individuals with IBD."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 years and older\n* Diagnosis of Inflammatory Bowel Disease (IBD) established for at least 6 months\n* Patient is motivated to participate in the Adapted Physical Activity (APA) program\n* Medical certificate confirming fitness to engage in remote physical activity\n* Access to a digital device with internet connectivity enabling use of the MOOV+ application at home\n* Written informed consent freely given after appropriate information\n* Affiliation with, or beneficiary of, a national health insurance system\n\nExclusion Criteria:\n\n* Patients under 18 years of age\n* Medical contraindication to physical activity\n* High levels of physical activity as defined by the International Physical Activity Questionnaire (IPAQ):\n\n * Total \\>1500 MET-min/week of vigorous activity on at least 3 days, OR\n * Total physical activity \\>3000 MET-min/week, regardless of distribution\n* Presence of psychological disorders that may interfere with study participation\n* Lack of access to a device or internet connection enabling remote participation\n* Pregnant or breastfeeding women\n* Patients under legal guardianship or curatorship\n* Patients under legal protection'}, 'identificationModule': {'nctId': 'NCT07191106', 'acronym': 'APIMICI', 'briefTitle': 'Pilot Study Assessing the Feasibility and Impact of a Remote Adapted Physical Activity Program on Quality of Life in Patients With Inflammatory Bowel Disease (IBD)', 'organization': {'class': 'NETWORK', 'fullName': 'Raincy Montfermeil Hospital Group'}, 'officialTitle': 'Pilot Feasibility and Impact Study of a Remote Adapted Physical Activity Program on the Quality of Life of Patients With Inflammatory Bowel Disease (IBD)', 'orgStudyIdInfo': {'id': 'GHIRM_RIRCM20241122'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pre- and post-intervention comparison following participation in the Adapted Physical Activity (APA)', 'description': 'There is no comparator group at this stage of the research. Patient data will be compared before and after participation in the Adapted Physical Activity (APA) program.', 'interventionNames': ['Procedure: adapted physical activity']}], 'interventions': [{'name': 'adapted physical activity', 'type': 'PROCEDURE', 'description': 'Comparative before-and-after study over a 3-month period of remote Adapted Physical Activity (APA) delivered through the MOOV+ application', 'armGroupLabels': ['Pre- and post-intervention comparison following participation in the Adapted Physical Activity (APA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93370', 'city': 'Montfermeil', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stephane NAHON, Professor', 'role': 'CONTACT', 'email': 'stephane.nahon@ght-gpne.fr', 'phone': '0033141708000'}], 'facility': 'GHI Le Raincy Montfermeil', 'geoPoint': {'lat': 48.8982, 'lon': 2.57913}}, {'zip': '44093', 'city': 'Nantes', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Catherine LE BERRE, Doctor', 'role': 'CONTACT', 'email': 'catherine.leberre@chu-nantes.fr', 'phone': '0033.2.40.08.33.33'}], 'facility': 'CHU Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'centralContacts': [{'name': 'Stephane NAHON, Professor', 'role': 'CONTACT', 'email': 'stephane.nahon@ght-gpne.fr', 'phone': '+33141708000'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Raincy Montfermeil Hospital Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Janssen Cilag S.A.S.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}