Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT05140967
Status:
COMPLETED
Last Update Posted:
2025-02-17
First Post:
2021-10-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Training Intensity on Physical Fitness and Body Composition in Cystic Fibrosis
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072696', 'term': 'High-Intensity Interval Training'}], 'ancestors': [{'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-13', 'studyFirstSubmitDate': '2021-10-29', 'studyFirstSubmitQcDate': '2021-12-01', 'lastUpdatePostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in Peak Oxygen Uptake', 'timeFrame': 'at baseline and after 4 weeks of exercise training program', 'description': 'measured with peak Oxygen uptake (VO2) in percent predicted'}, {'measure': 'change in Peak Workload', 'timeFrame': 'at baseline and after 4 weeks of exercise training program', 'description': 'measured with peak Workload in percent predicted'}, {'measure': 'change body fat mass index', 'timeFrame': 'at baseline and after 4 weeks of exercise training program', 'description': 'measured with body fat mass index (FMI) in kg / m\\*2'}, {'measure': 'change in Body fat free mass index', 'timeFrame': 'at baseline and after 4 weeks of exercise training program', 'description': 'measured with fat free body mass index (FFMI) in kg / m\\*2'}], 'secondaryOutcomes': [{'measure': 'change in Forced Expiratory Volume in 1 second', 'timeFrame': 'at baseline and after 4 weeks of exercise training program', 'description': 'measured with Forced Expiratory Volume in 1 second (FEV1) in percent predicted'}, {'measure': 'change in Health related quality of life', 'timeFrame': 'at baseline and six and twelve months after completion of exercise training program', 'description': 'measured with the Cystic Fibrosis Questionnaire Revised (CFQ-R); 9 Quality of life domains: Physical, role/school, vitality, emotion, social, body image, eating, treatment burden, health perceptions: 3 symptom scales: Weight, respiratory, and digestion Scores range from 0 to 100, with higher scores indicating better health.'}, {'measure': 'appetite control - subjective feeling of hunger', 'timeFrame': 'at baseline and after 4 weeks of exercise training program', 'description': 'measured with visual analogue scales. The scale consists of a 10 cm vertical line anchored with "not hungry at all" at the left side and with "extremely hungry" at the right side.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise training', 'High Intensity Interval Training (HIIT)', 'Moderate Intensity Continuous Training (MICT)', 'Exercise capacity', 'Peak Oxygen uptake (VO2peak)', 'Body-composition', 'Subjective appetite and satiety ratings', 'Appetite regulating hormones', 'Health related quality of life', 'Habitual physical activity', 'ad libitum energy intake'], 'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'Aim of the randomized controlled trial is to investigate the effects of endurance training with different intensities on physical performance, body composition and appetite regulation in people with cystic fibrosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* confirmed diagnosis of cystic fibrosis by at least 2 sweat tests and / or by the presence of two CF mutations,\n* willingness to participate in and to comply with the research project procedure,\n* written informed consent of patients,\n* age ≥ 18 years,\n* FEV1 of pred. ≥ 40%,\n* Stable condition (as indicated by absence of one or more signs: new or increased haemoptysis, increased malaise, fatigue or lethargy, temperature over 38°C, weight loss, sinus pain and a decrease in pulmonary function by 10% or more)\n\nExclusion Criteria:\n\n* Severe pulmonary exacerbation,\n* cor pulmonale,\n* musculoskeletal discomfort that makes a regular exercise training impossible,\n* untreated CF-related diabetes'}, 'identificationModule': {'nctId': 'NCT05140967', 'briefTitle': 'Effects of Training Intensity on Physical Fitness and Body Composition in Cystic Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Kiel'}, 'officialTitle': 'Effects of Endurance Training Intensity on Exercise Capacity, Body Composition, and Appetite Regulation in Cystic Fibrosis', 'orgStudyIdInfo': {'id': 'ABW-2021-CF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High Intensity Interval Training (A)', 'description': 'Exercise training with intermittent bouts of high intensity', 'interventionNames': ['Other: High Intensity Interval Training (HIIT)']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate Intensity Continous Training (B)', 'description': 'Exercise training with constant workload', 'interventionNames': ['Other: Moderate Continuous Intensity Training (MICT)']}], 'interventions': [{'name': 'High Intensity Interval Training (HIIT)', 'type': 'OTHER', 'description': 'High Intensity Interval Training', 'armGroupLabels': ['High Intensity Interval Training (A)']}, {'name': 'Moderate Continuous Intensity Training (MICT)', 'type': 'OTHER', 'description': 'Moderate Intensity Continuous Training', 'armGroupLabels': ['Moderate Intensity Continous Training (B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25946', 'city': 'Nebel / Amrum', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'Fachklink Satteldüne der DRV Nord'}, {'zip': '25826', 'city': 'Sankt Peter-Ording', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'Strandklinik St. Peter-Ording', 'geoPoint': {'lat': 54.30363, 'lon': 8.64138}}], 'overallOfficials': [{'name': 'Anja Bosy-Westhphal, Prof, PhD, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Insitute of Human Nutrition, University of Kiel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kiel', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fachklinik Satteldüne der DRV Nord', 'class': 'UNKNOWN'}, {'name': 'University of Kiel, Arbeitsbereich Sportmedizin und Trainingswissenschaften', 'class': 'UNKNOWN'}, {'name': 'Strandklinik St. Peter-Ording', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Dr. Anja Bosy-Westphal', 'investigatorFullName': 'Prof. Dr. Dr. Anja Bosy-Westphal', 'investigatorAffiliation': 'University of Kiel'}}}}