Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 2:36 PM
Study NCT ID:
NCT07442851
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SickleFit Randomized Control Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009752', 'term': 'Nutritional Status'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'We will conduct a 12-week randomized control trial of a combined SickleFit exercise plus dietitian-led nutrition education intervention to be delivered virtual via Zoom in 40 adults (age ≥ 35) with sickle cell disease. There will be 20 participants in the SickleFit arm and 20 participants in the control arm. Randomization will be done 1:1.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-24', 'studyFirstSubmitDate': '2026-02-20', 'studyFirstSubmitQcDate': '2026-02-24', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Performance on the Sickle Cell Disease Functional Assessment (SCD-FA)', 'timeFrame': 'From baseline assessment to completion of the post-assessment within 6 months', 'description': 'Change in physical performance and patient-reported outcomes on the Sickle Cell Disease Functional Assessment (SCD-FA)'}], 'primaryOutcomes': [{'measure': 'Feasibility of Randomization', 'timeFrame': 'From enrollment to the last paticipants randomized over a 2 year period', 'description': 'Feasibility of randomization (proportion of participants randomized out of those approached)'}, {'measure': 'Safety/Adverse Events', 'timeFrame': 'adverse events will be measured for both arms up to 6 months', 'description': 'number of life-threatening adverse events'}, {'measure': 'Acceptability', 'timeFrame': 'From enrollment to after completion of the SickleFit Program over 6 months since we will also measure acceptability for control group', 'description': 'Proportion of participants reporting satisfaction with the program'}, {'measure': 'Retention in the program', 'timeFrame': 'From the baseline Sickle Cell Disease Functional Assessment to the post-SCD-FA. Over a 30 week period since post assessments will be completed within 3 months of completion of the SickleFit program or control period.', 'description': 'retention (proportion of the SickleFit and control groups completing follow up assessment)'}, {'measure': 'Adherence', 'timeFrame': 'From the start of the first SickleFit session to the end of the SickleFit program at 12 weeks', 'description': 'Adherence (proportion attending ≥ 50% of classes) in the SickleFit arm'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sickle cell disease', 'exercise', 'nutrition', 'aging', 'functional impairment'], 'conditions': ['Sickle Cell Disease', 'Aging']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Charity I Oyedeji, Teagan Callaway, Rania Mohamed, Reena Ravi, Richard Faldowski, Corey Vessels, Miriam C Morey, John J Strouse; The Sicklefit Exercise Program for Older Adults with Sickle Cell Disease: Feasibility, Acceptability, and Safety. Blood 2024; 144 (Supplement 1): 604. doi: https://doi.org/10.1182/blood-2024-212100'}]}, 'descriptionModule': {'briefSummary': 'To goal of this study is to pilot the SickleFit exercise and nutrition intervention in adults with sickle cell disease in a randomized control trial', 'detailedDescription': 'We will pilot the SickleFit personalized exercise plus dietitian-facilitated nutrition intervention randomized control trial in adults (age ≥ 35 years) with sickle cell disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Laboratory-confirmed diagnosis of sickle cell disease (any genotype)\n* Understand and speak English by self-report\n* Age ≥ 35 years old\n\nExclusion Criteria:\n\n* Oxygen dependence\n* Unstable cardiac disease\n* Wheelchair-bound\n* Diagnosed with severe cognitive impairment based on ICD-10 codes or reported by their outpatient provider\n* Unable to self-consent\n* Severe uncorrected visual or auditory impairment\n* Pregnant\n* Successfully treated with hematopoietic stem cell transplantation or gene therapy for sickle cell disease'}, 'identificationModule': {'nctId': 'NCT07442851', 'briefTitle': 'SickleFit Randomized Control Trial', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'The SickleFit Exercise and Nutrition Randomized Control Trial for Older Adults With Sickle Cell Disease', 'orgStudyIdInfo': {'id': 'Pro00118037'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SickleFit arm', 'description': 'Participants in SickleFit arm will complete the Sickle Cell Disease Functional Assessment before and after 12 weeks of SickleFit exeercise+Nutrition intervention.', 'interventionNames': ['Behavioral: SickleFit Exercise plus Nutrition']}, {'type': 'NO_INTERVENTION', 'label': 'Control Arm', 'description': 'Participants in the control arm will be on a wait list for SickleFit and will continue to receive usual care during that 12-week period. They will complete the Sickle Cell Disease Functional Assessment at baseline and after 12 weeks on the wait list. After their post-assessment, they will have the option to complete 12 weeks of SickleFit exercise+Nutrition intervention.'}], 'interventions': [{'name': 'SickleFit Exercise plus Nutrition', 'type': 'BEHAVIORAL', 'description': 'SickleFit personalized exercise plus dietitian-facilitated nutrition intervention', 'armGroupLabels': ['SickleFit arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'contacts': [{'name': 'Teagan Callaway', 'role': 'CONTACT', 'email': 'teagan.callaway@duke.edu', 'phone': '919-684-0628'}, {'name': 'Rania Mohamed', 'role': 'CONTACT', 'email': 'rania.mohamed@duke.edu'}, {'name': 'Charity I Oyedeji, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'John J Strouse, MD PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kathryn Starr, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'centralContacts': [{'name': 'Teagan Callaway', 'role': 'CONTACT', 'email': 'SICKLEFIT@duke.edu', 'phone': '919-684-0628'}, {'name': 'Rania Mohamed', 'role': 'CONTACT', 'email': 'rania.mohamed@duke.edu'}], 'overallOfficials': [{'name': 'Charity I Oyedeji, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}