Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-29 @ 7:34 PM
Study NCT ID:
NCT00609050
Status:
COMPLETED
Last Update Posted:
2016-02-19
First Post:
2008-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Training Study for Patients With Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-18', 'studyFirstSubmitDate': '2008-01-31', 'studyFirstSubmitQcDate': '2008-02-01', 'lastUpdatePostDateStruct': {'date': '2016-02-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiopulmonary Fitness: Peak VO2', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Cardiopulmonary fitness: VO2150 and peak power output', 'timeFrame': '1 year'}, {'measure': 'Pulmonary function: FEV1 and sustained phonation time', 'timeFrame': '1 year'}, {'measure': 'Health-related quality of life: Quality of well-being scale and cystic fibrosis questionnaire', 'timeFrame': '1 Year'}, {'measure': 'Exercise experiences of children and parents: Interviews', 'timeFrame': '1 Year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cystic fibrosis', 'exercise', 'perceived exertion', 'aerobic fitness', 'lung function', 'health related quality of life', 'self-regulated exercise'], 'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to test the effect of a 6-month program of self-regulated, home-based exercise with telephone reinforcement on the cardiorespiratory fitness, pulmonary function and health-related quality of life of children with cystic fibrosis (CF), compared to controls. Exploring the exercise experiences of the children and parents is a secondary aim.', 'detailedDescription': 'CF is a life-long illness that requires complex and dynamic adjustment by the patient and family. The nursing role is vital to the multidisciplinary team approach required in providing comprehensive, individualized care for these patients. Nurses facilitate the coordination of health care efforts and support the patient and family across physical and psychosocial domains. With the well-documented correlation between exercise tolerance and both survival and HRQoL, exercise represents a critical treatment focus for CF patients. Nurses contribute to standard exercise rehabilitation programs, through education, psychosocial support, and communication. In this exercise training study, the nursing role will include: a) teaching the patients and families how to use the OMNI scale, b) confirming that they understand the home-based exercise regimen, and c) ensuring that the home-care program is properly followed by placing weekly telephone calls to assess progress and barriers. Long-term nursing application will occur via dissemination of the OMNI training manual, to be developed as part of this study, for use by CF nurses in clinics worldwide.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CF diagnosis\n* age 10-18 years\n* reliable pulmonary function tests\n* living at home\n* able to read\n* able to ride a stationary bike\n* able to walk and/or run on a treadmill.\n\nExclusion Criteria:\n\n* Enrolled in another intervention study\n* in structured aerobic activity for 30 continuous minutes 3 times per week\n* sibling enrolled in study.'}, 'identificationModule': {'nctId': 'NCT00609050', 'briefTitle': 'Exercise Training Study for Patients With Cystic Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Self-Regulated Exercise in CF: A Randomized Trial', 'orgStudyIdInfo': {'id': 'R01NR009285', 'link': 'https://reporter.nih.gov/quickSearch/R01NR009285', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01NR009285', 'link': 'https://reporter.nih.gov/quickSearch/R01NR009285', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Self-Regulated Exercise with Telephone Reinforcement', 'interventionNames': ['Behavioral: Self-Regulated Exercise with Telephone Reinforcement', 'Behavioral: Qualitative Approach']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Attention Control', 'interventionNames': ['Behavioral: Standard Treatment', 'Behavioral: Qualitative Approach']}], 'interventions': [{'name': 'Self-Regulated Exercise with Telephone Reinforcement', 'type': 'BEHAVIORAL', 'description': 'The self-regulated exercise with telephone reinforcement group will engage in a three-times-a-week (or more) at home exercise regimen for 6 months during which they may choose the mode of exercise. They will receive weekly telephone calls about exercise and airway clearance. After 6 months, they will be instructed to maintain their self-regulated exercise activity for the remaining 6 months of the study, but they will not receive telephone calls', 'armGroupLabels': ['1']}, {'name': 'Standard Treatment', 'type': 'BEHAVIORAL', 'description': 'The attention control group will receive standard recommendations for exercise activity, during the first 6 months, as is common in our clinic. Also during the first 6 months, they will receive weekly telephone calls about airway clearance. For the final 6 months of the study, the attention control group will cross over to self-regulated exercise without telephone reinforcement.', 'armGroupLabels': ['2']}, {'name': 'Qualitative Approach', 'type': 'BEHAVIORAL', 'description': 'A qualitative naturalistic approach is nested within the primary experimental framework to explore the experiences of the children and parents, in both groups, with the exercise regimen.', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Antiono J & Janet Palumbo Cystic Fibrosis Center; Children's Hospital of Pittsburgh of UPMC", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'David M Orenstein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pediatrics', 'investigatorFullName': 'David Orenstein', 'investigatorAffiliation': 'University of Pittsburgh'}}}}