Ignite Creation Date:
2025-12-17 @ 1:41 PM
Ignite Modification Date:
2025-12-23 @ 4:55 PM
Study NCT ID:
NCT01744561
Status:
COMPLETED
Last Update Posted:
2018-10-22
First Post:
2012-12-05
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of a Partially Supervised Conditioning Program in CF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 155}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-18', 'studyFirstSubmitDate': '2012-12-05', 'studyFirstSubmitQcDate': '2012-12-05', 'lastUpdatePostDateStruct': {'date': '2018-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Compliance with the exercise goal', 'timeFrame': 'baseline to 6 months and baseline to 12 months', 'description': 'based on questionnaire and diary'}, {'measure': 'Change in lung clearance index', 'timeFrame': 'baseline to 6 months and baseline to 12 months', 'description': 'based on nitrogen multiple breath washout, in selected centres only'}, {'measure': 'Change in time spent in moderate-and-vigorous physical activity', 'timeFrame': 'baseline to 6 months and baseline to 12 months', 'description': 'based on accelerometry, in selected centres only'}, {'measure': 'Change in bone mineral density and body composition', 'timeFrame': 'baseline to 6 months and baseline to 12 months', 'description': 'based on dual energy x-ray absorptiometry, in selected centres only'}, {'measure': 'Change in mucociliary clearance with exercise', 'timeFrame': 'baseline to 6 months', 'description': 'based on nuclear medicine scans, US centres only'}], 'primaryOutcomes': [{'measure': 'Change in forced expiratory volume in 1 second (FEV1; in % predicted using the average of two baseline measurements) from baseline to 6 months in the intervention group compared to controls.', 'timeFrame': 'baseline and 6 months'}], 'secondaryOutcomes': [{'measure': 'Change in peak oxygen uptake (%predicted)', 'timeFrame': 'baseline to 6 months and baseline to 12 months'}, {'measure': 'Change in maximal aerobic power (%predicted)', 'timeFrame': 'baseline to 6 months and baseline to 12 months'}, {'measure': 'Change in measured steps per day', 'timeFrame': 'baseline to 6 months and baseline to 12 months'}, {'measure': 'Change in exercise steps per day', 'timeFrame': 'baseline to 6 months and baseline to 12 months'}, {'measure': 'Change in reported physical activity', 'timeFrame': 'baseline to 6 months and baseline to 12 months'}, {'measure': 'Change in forced expiratory volume in 1 second (FEV1; %predicted)', 'timeFrame': 'baseline to 6 months and baseline to 12 months'}, {'measure': 'Change in forced vital capacity (FVC; % predicted)', 'timeFrame': 'baseline to 6 months and baseline to 12 months'}, {'measure': 'Change in residual volume in percent of total lung capacity (RV/TLC; %)', 'timeFrame': 'baseline to 6 months and baseline to 12 months'}, {'measure': 'Time to first exacerbation', 'timeFrame': 'baseline to 6 months and baseline to 12 months'}, {'measure': 'Number of upper respiratory tract infections', 'timeFrame': 'baseline to 6 months and baseline to 12 months', 'description': 'from diary'}, {'measure': 'Days on additional oral / intravenous antibiotics', 'timeFrame': 'baseline to 6 months and baseline to 12 months', 'description': 'from questionnaire'}, {'measure': 'Change in body mass index (kg/m2)', 'timeFrame': 'baseline to 6 months and baseline to 12 months'}, {'measure': 'Change in muscle mass (kg)', 'timeFrame': 'baseline to 6 months and baseline to 12 months', 'description': 'estimated from skinfold thickness'}, {'measure': 'Change in percent body fat', 'timeFrame': 'baseline to 6 months and baseline to 12 months', 'description': 'estimated from skinfold thickness'}, {'measure': 'Change in Quality of Life scales', 'timeFrame': 'baseline to 6 months and baseline to 12 months', 'description': 'from the revised Cystic Fibrosis health-related quality of life Questionnaire (CFQ-R questionnaire)'}, {'measure': 'Change in depression, anxiety and stress scores', 'timeFrame': 'baseline to 6 months and baseline to 12 months', 'description': 'from Depression Anxiety Stress Scales'}, {'measure': 'Change in plasma glucose concentrations 1 and 2 hours after a standardized glucose load', 'timeFrame': 'baseline to 9 months', 'description': 'standardized oral glucose tolerance test only patients without diabetes mellitus'}, {'measure': 'Adverse events possibly or likely related to exercise', 'timeFrame': 'baseline to 6 months and baseline to 12 months', 'description': 'causality as judged by investigator'}, {'measure': 'Severe adverse events', 'timeFrame': 'baseline to 6 months and baseline to 12 months'}, {'measure': 'Serious adverse events', 'timeFrame': 'baseline to 6 months and baseline to 12 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise', 'Motivation', 'Feedback', 'web-based diary', 'pedometer'], 'conditions': ['Cystic Fibrosis']}, 'referencesModule': {'references': [{'pmid': '29422091', 'type': 'BACKGROUND', 'citation': 'Hebestreit H, Lands LC, Alarie N, Schaeff J, Karila C, Orenstein DM, Urquhart DS, Hulzebos EHJ, Stein L, Schindler C, Kriemler S, Radtke T; ACTIVATE-CF Study Working Group. Effects of a partially supervised conditioning programme in cystic fibrosis: an international multi-centre randomised controlled trial (ACTIVATE-CF): study protocol. BMC Pulm Med. 2018 Feb 8;18(1):31. doi: 10.1186/s12890-018-0596-6.'}]}, 'descriptionModule': {'briefSummary': 'Physical activity and exercise have become an accepted and valued component of Cystic Fibrosis care. Regular physical activity and exercise can slow the rate of decline of pulmonary function, improve physical fitness, and enhance quality of life. However, motivating people to be more active is challenging. Supervised exercise programs are expensive and labor intensive, and adherence falls off significantly once supervision ends. Unsupervised or partially supervised programs are less costly and more flexible, but compliance can be more problematic. The primary objective of this study is to evaluate the effects of a 12-months partially supervised exercise intervention along with regular motivation on forced expiratory volume in 1 second (FEV1) in a large international group of cystic fibrosis patients. Secondary endpoints include patient reported quality of life, as well as levels of anxiety and depression, and control of blood sugar. A total of 292 patients with cystic fibrosis 12 years and older with a FEV1 ≥35% predicted will be recruited. Following baseline assessments (2 visits) patients will be randomized into an intervention and a control group. Thereafter, they will be seen every 3 months for assessments in their centre for one year (4 follow-up visits). Along with individual counseling to increase vigorous physical activity by at least 3 hours per week on each clinic visit, the intervention group will document daily exercise and inactivity time and will receive a step counter and they will record their progress with a web-based program. They will also receive monthly phone calls from the study staff. After 6 months, they will continue with the step counter and web-based program for a further 6 months. The control group will receive access to this intervention after 12 months of standardized care. Should this relatively simple program prove successful, this will be made available on a wider scale internationally.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of Cystic Fibrosis\n* Age ≥12 years\n* Forced expiratory volume in 1 second (FEV1) ≥ 35% predicted\n* Access to the internet\n\nExclusion Criteria:\n\n* Participation in another clinical trial up to 4 weeks prior to the first baseline visit\n* Pregnancy/Breastfeeding\n* Inability to exercise\n* More than 4 hours of reported strenuous physical activities per week currently or up to 3 months prior to baseline measurements and not already planned within the coming 6 months.\n* Unstable condition precluding exercise (major hemoptysis or pneumothorax within the last 3 months, acute exacerbation and iv-antibiotics during the last 4 weeks, planned surgery, listed for lung transplantation, major musculoskeletal injuries such as fractures or sprains during the last 2 months, others according to the impression of the doctor)\n* Cardiac arrhythmias with exercise\n* Requiring additional oxygen with exercise\n* Recent diagnosis of diabetes 3 months prior to screening or at screening\n* Recent changes in medication 1 month or less prior to screening (systemic steroids, ibuprofen, inhaled antibiotics, mannitol, DNAse, hypertonic saline)\n* At least one G551D mutation and not on ivacaftor (VX770) yet but planned start or planned stop of ivacaftor during the trial\n* Colonization with Burkholderia cenocepacia'}, 'identificationModule': {'nctId': 'NCT01744561', 'acronym': 'ACTIVATE-CF', 'briefTitle': 'Effects of a Partially Supervised Conditioning Program in CF', 'organization': {'class': 'OTHER', 'fullName': 'Wuerzburg University Hospital'}, 'officialTitle': 'Effects of a Partially Supervised Conditioning Program in CF: an International Multi-centre, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'ACT-CF-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise Intervention', 'description': 'Add three hours of intense physical activities per week to baseline activities. Weekly exercise should include at least 30 minutes of strength building activities and at least two hours of aerobic activities. Exercise bouts lasting 20 min or longer will be counted with respect to total weekly training time.', 'interventionNames': ['Behavioral: Exercise Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Keep activity level constant'}], 'interventions': [{'name': 'Exercise Intervention', 'type': 'BEHAVIORAL', 'description': 'Add three hours of intense physical activities per week to baseline activities. Weekly exercise should include at least 30 minutes of strength building activities and at least two hours of aerobic activities. Exercise bouts lasting 20 min or longer will be counted with respect to total weekly training time.', 'armGroupLabels': ['Exercise Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294-1212', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Pittsburgh of UPMC", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'Mukoviszidose-Ambulanz, Universitätsklinik für Kinder- und Jugendheilkunde,', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '6020', 'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Cystische Fibrose Zentrum für Kinder, Jugendliche und Erwachsene', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': 'H4A 3J1', 'city': 'Monrtreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Montreal Children's Hospital, McGill University Health Centre - Glen Site"}, {'zip': '83406', 'city': 'Hyères', 'country': 'France', 'facility': 'Hôpital Renée Sabran, Service : Maladies respiratoires', 'geoPoint': {'lat': 43.12038, 'lon': 6.12857}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Calmette, Service Pneumologie-immuno-allergologie boulevard du Pr Leclercq', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Jeanne de Flandre, Service: Pneumologie et allergologie pédiatriques', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Hôpital Arnaud de Villeneuve, Service: Maladies respiratoires', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Necker, Service : Pneumologie et allergologie pédiatriques', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '51092', 'city': 'Reims', 'country': 'France', 'facility': 'Hôpital Maison Blanche, Service : Maladies respiratoires', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '70174', 'city': 'Stuttgart', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Olgahospital, Klinikum Stuttgart', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': '72076', 'city': 'Tübingen', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Klinik für Kinder- und Jugendmedizin, Universitätsklinikum Tübingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': '97080', 'city': 'Würzburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Children´s Hospital of the University', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'zip': '44791', 'city': 'Bochum', 'country': 'Germany', 'facility': 'Pediatric Pulmonology and CF centre, Children´s Hospital, Ruhr University', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Klinik und Poliklinik für Kinderheilkunde - Universitäts-Mukoviszidose-Centrum', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '60323', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Christiane Herzog CF-Zentrum, Goethe Universität', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '22763', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'CF Zentrum Hamburg-Altona, Kinderarztpraxis Runge, Sextro,Held', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'CF- Ambulanz, Kinderklinik, Pädiatrische Pneumologie, Allergologie und Neonatologie', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '55101', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Zentrum für Kinder- und Jugendmedizin, Pädiatrische Pneumologie, Allergologie und Mukoviszidose', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '81241', 'city': 'Munich', 'country': 'Germany', 'facility': 'Praxis für Lungen- und Bronchialheilkunde', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '48149', 'city': 'Münster', 'country': 'Germany', 'facility': 'Klinik für Kinder- und Jugendmedizin / Universitätsklinikum', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'city': 'Utrecht', 'country': 'Netherlands', 'facility': "University Medical Center, Child Development & Exercise Center, Wilhelmina Children's Hospital", 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '3001', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'QuartierBleu, Praxis für Pneumologie am Lindenhofspital', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'city': 'Bern', 'country': 'Switzerland', 'facility': 'Inselspital, Universitätsklinik für Kinderheilkunde, Pneumologie', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'zip': '8032', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Kinderspital, Pneumologie', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'UniversitätsSpital, Klinik für Pneumologie', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': 'EH9 1LF', 'city': 'Edinburgh', 'state': 'Scottland', 'country': 'United Kingdom', 'facility': 'Royal Hospital for Sick Children', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}], 'overallOfficials': [{'name': 'Helge U Hebestreit, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wuerzburg University Hosptitals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wuerzburg University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Dr. med.', 'investigatorFullName': 'Prof. Helge Hebestreit', 'investigatorAffiliation': 'Wuerzburg University Hospital'}}}}