Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-25 @ 9:32 PM
Study NCT ID:
NCT06457451
Status:
RECRUITING
Last Update Posted:
2025-12-01
First Post:
2024-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of a Coordinated Dietetic-adapted Physical Activity Program on the Percentage of Lean Body Mass in Adults With Cystic Fibrosis Treated With Elexacaftor-Tezacaftor-Ivacaftor: Multicentre Randomised Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-27', 'studyFirstSubmitDate': '2024-06-07', 'studyFirstSubmitQcDate': '2024-06-07', 'lastUpdatePostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evolution of percentage of patients lean mass as a percentage of body mass', 'timeFrame': 'From randomization, up to 12 months', 'description': 'Impedancemetry'}], 'secondaryOutcomes': [{'measure': 'Evolution of percentage of patients fat mass as a percentage of body mass', 'timeFrame': 'From randomization, up to 12 months', 'description': 'impedancemetry'}, {'measure': 'Weight evolution', 'timeFrame': 'From randomization, up to 12 months', 'description': 'Weight measurement'}, {'measure': 'Body Mass Index (BMI) evolution', 'timeFrame': 'From randomization, up to 12 months', 'description': 'Weight and height measurement'}, {'measure': 'Cardio-respiratory endurance', 'timeFrame': 'From randomization, up to 12 months', 'description': '6-Minute Walk Test (6MWT)'}, {'measure': 'Bilateral Handgrip strength', 'timeFrame': 'From randomization, up to 12 months', 'description': 'Handgrip Test'}, {'measure': 'Lower limb muscle power', 'timeFrame': 'From randomization, up to 12 months', 'description': '30-second Sit-to-Stand test'}, {'measure': 'Upper limb muscle power', 'timeFrame': 'From randomization, up to 12 months', 'description': 'Pump test'}, {'measure': 'Static trunck extensors muscle endurance', 'timeFrame': 'From randomization, up to 12 months', 'description': '"Superman" test'}, {'measure': 'Static trunck flexors muscle endurance', 'timeFrame': 'From randomization, up to 12 months', 'description': 'Shirado-Ito test'}, {'measure': 'Balance between static muscular endurance of extensors and flexors', 'timeFrame': 'From randomization, up to 12 months', 'description': 'Calculated using the Shirado-Ito/"Superman" ratio'}, {'measure': 'Posterior chain flexibility (Hamstring, hips and lower back)', 'timeFrame': 'From randomization, up to 12 months', 'description': 'Front trunk flexion test'}, {'measure': 'Upper limb flexibility', 'timeFrame': 'From randomization, up to 12 months', 'description': 'scapulohumeral mobility test'}, {'measure': 'Forced Expiratory Volume in 1 second (FEV1)', 'timeFrame': 'From randomization, up to 12 months', 'description': 'Spirometry'}, {'measure': 'Physical activity volume and sedentary time', 'timeFrame': 'From randomization, up to 12 months', 'description': 'Physical activity and sedentary behavior self-questionnaire (ONAPS-PAQ)'}, {'measure': 'Evolution of quality of life', 'timeFrame': 'From randomization, up to 12 months', 'description': 'Cystic Fibrosis Questionnaire-Revised (CFQR-14)'}, {'measure': 'Program feedback questionnaire', 'timeFrame': '12 months after randomization', 'description': 'Self-questionnaire about how patients in the experimental group feel about the program'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Elexacaftor-Tezacaftor-Ivacaftor', 'Cystic Fibrosis', 'Adapted Physical Activity', 'Body composition', 'Dietetic'], 'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'Cystic fibrosis is an autosomal recessive inherited disease linked to various mutations in the gene coding for the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) protein, with respiratory and digestive disorders conditioning the prognosis.\n\nDigestive damage may be responsible for malnutrition of multifactorial origin (insufficient energy intake, increased energy losses, increased basal metabolic rate), and studies show a correlation between reduced lean body mass and respiratory function.\n\nIn 2019, the French National Authority for Health (HAS) redefined undernutrition by including "quantified reduction in muscle mass and/or function" as a phenotypic diagnostic criterion.\n\nElexacaftor-Tezacaftor-Ivacaftor, an innovative therapy (authorization in 2021) for this population, aims to restore the function of CFTR protein. Significant improvements in lung function and weight gain were observed from the first weeks of treatment. These improvements have also led to the emergence of lesser-known nutritional problems in these patients, such as overweight and the development of metabolic complications. Nonetheless, new management options in terms of dietary adjustments and adapted physical activity for these patients are possible, given the development of their abilities.\n\nAdapted Physical Activity (APA) helps to improve general muscular function by strengthening respiratory and skeletal muscles, improving aerobic capacity, and aiding bronchial drainage through muscle strengthening and endurance work. Maintaining or even increasing muscle mass depends not only on appropriate food intake and optimal dietary management, but also on regular physical activity, as recommended by the HAS.\n\nOur hypothesis is therefore that a structured dietetic/adapted physical activity program (DIAPASOM program) can increase the percentage of lean body mass at 12 months in adult cystic fibrosis patients treated with Elexacaftor-Tezacaftor-Ivacaftor.', 'detailedDescription': 'Cystic fibrosis is an autosomal recessive inherited disease linked to various mutations in the gene coding for the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) protein, with respiratory and digestive disorders conditioning the prognosis.\n\nDigestive damage may be responsible for malnutrition of multifactorial origin (insufficient energy intake, increased energy losses, increased basal metabolic rate), and studies show a correlation between reduced lean body mass and respiratory function.\n\nIn 2019, the French National Authority for Health (HAS) redefined undernutrition by including "quantified reduction in muscle mass and/or function" as a phenotypic diagnostic criterion.\n\nElexacaftor-Tezacaftor-Ivacaftor, an innovative therapy (authorization in 2021) for this population, aims to restore the function of CFTR protein. Significant improvements in lung function and weight gain were observed from the first weeks of treatment. These improvements have also led to the emergence of lesser-known nutritional problems in these patients, such as overweight and the development of metabolic complications. Nonetheless, new management options in terms of dietary adjustments and adapted physical activity for these patients are possible, given the development of their abilities.\n\nAdapted Physical Activity (APA) helps to improve general muscular function by strengthening respiratory and skeletal muscles, improving aerobic capacity, and aiding bronchial drainage through muscle strengthening and endurance work. Maintaining or even increasing muscle mass depends not only on appropriate food intake and optimal dietary management, but also on regular physical activity, as recommended by the HAS.\n\nOur hypothesis is therefore that a structured dietetic/adapted physical activity program (DIAPASOM program) can increase the percentage of lean body mass at 12 months in adult cystic fibrosis patients treated with Elexacaftor-Tezacaftor-Ivacaftor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject aged 18 or over\n* Suffering from cystic fibrosis\n* Treated with Elexacaftor-Tezacaftor-Ivacaftor for at least 6 months\n* Affiliated to a social security scheme\n* with a signed Informed Consent form.\n\nExclusion Criteria:\n\n* Pregnant and breast-feeding women\n* Subject under legal protection, guardianship or curatorship\n* Subject whose physical activity is not medically authorised or whose physical and motor capacities do not allow them to take part in physical activity.\n* Subject who is unable to comply with the requirements of the DIAPASOM program\n* Difficulty in understanding the self-questionnaires\n* Wearing a pacemaker or metal prosthesis\n* Fluid retention'}, 'identificationModule': {'nctId': 'NCT06457451', 'acronym': 'DIAPASOM', 'briefTitle': 'Impact of a Coordinated Dietetic-adapted Physical Activity Program on the Percentage of Lean Body Mass in Adults With Cystic Fibrosis Treated With Elexacaftor-Tezacaftor-Ivacaftor: Multicentre Randomised Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Tours'}, 'officialTitle': "Impact d'un Programme coordonné diététique-activité Physique adaptée Sur le Pourcentage de Masse Maigre d'Adultes Atteints de Mucoviscidose traités Par Elexacaftor-Tezacaftor-Ivacaftor : Essai contrôlé randomisé Multicentrique", 'orgStudyIdInfo': {'id': '2023-A02715-40'}, 'secondaryIdInfos': [{'id': 'DR220270', 'type': 'OTHER', 'domain': 'Sponsor'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DIAPASOM program', 'description': 'Program of adapted physical activity carried out remotely by a specialized instructor for one year:\n\n* Phase 1 (3 months): 2 supervised weekly sessions.\n* Phase 2 (3months): 1 supervised weekly session and 1 independent weekly session.\n* Phase 3 (6months): 2 independent weekly sessions with monthly telephone follow-up.\n\nCombined with personalized dietetic care by a dietician for one year too:\n\nIn person dietetic consultation every 3 months to monitor personalized objectives, with telephone follow-up between each face-to-face consultation to improve compliance.', 'interventionNames': ['Other: DIAPASOM program']}, {'type': 'NO_INTERVENTION', 'label': 'Management as usual', 'description': 'Management of nutrition and physical activity as usual'}], 'interventions': [{'name': 'DIAPASOM program', 'type': 'OTHER', 'description': 'A program of adapted physical activity carried out remotely by a specialist instructor, combined with personalized dietetic care by a dietician for one year.', 'armGroupLabels': ['DIAPASOM program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49033', 'city': 'Angers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pascaline PRIOU, MD', 'role': 'CONTACT'}, {'name': 'Pascaline PRIOU, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cystic Fibrosis Resource and Competence Centre, University Hospital, Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '29684', 'city': 'Roscoff', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sophie RAMEL, MD', 'role': 'CONTACT'}, {'name': 'Sophie RAMEL, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cystic Fibrosis Resource and Competence Centre, Fondation Ildys, Roscoff', 'geoPoint': {'lat': 48.72381, 'lon': -3.98709}}, {'zip': '37044', 'city': 'Tours', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Julie MANKIKIAN, MD', 'role': 'CONTACT'}, {'name': 'Julie MANKIKIAN, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cystic Fibrosis Resource and Competence Centre, University Hospital, Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '56017', 'city': 'Vannes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Baptiste ARNOUAT, MD', 'role': 'CONTACT'}, {'name': 'Baptiste ARNOUAT, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cystic Fibrosis Resource and Competence Centre, Hospital, Tours', 'geoPoint': {'lat': 47.65688, 'lon': -2.76205}}], 'centralContacts': [{'name': 'Amelie GIBORY', 'role': 'CONTACT', 'email': 'a.gibory@chu-tours.fr', 'phone': '0247474747', 'phoneExt': '+33'}, {'name': 'Arnaud DE LUCA, MD', 'role': 'CONTACT', 'email': 'a.deluca@chu-tours.fr'}], 'overallOfficials': [{'name': 'Julie MANKIKIAN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Tours'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Tours', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondation Ildys', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}