Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-26 @ 6:28 PM
Study NCT ID:
NCT05789433
Status:
RECRUITING
Last Update Posted:
2025-07-03
First Post:
2023-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Aerobic Exercise on Skeletal Muscle Remodeling in Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'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': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-01', 'studyFirstSubmitDate': '2023-03-16', 'studyFirstSubmitQcDate': '2023-03-28', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Whole-Body Intermuscular Adipose Tissue', 'timeFrame': 'up to Week 12', 'description': 'Mean (kg) whole-body intermuscular adipose tissue quantified using magnetic resonance imaging.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colonic Neoplasms', 'Rectal Neoplasms']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to quantify the effects of aerobic exercise training compared to attention control on intermuscular adipose tissue in colorectal cancer survivors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥18 years\n* Histologically confirmed stage I, II, or III colon or rectal cancer\n* Completed surgical resection with curative intent\n* Completed other cancer-directed treatments\n* Engage in \\<150 minutes per week of moderate- to vigorous-intensity structured endurance exercise\n* No planned major surgery during the study period\n* Readiness to exercise, as determined by a modified version of the Physical Activity Readiness Questionnaire\n* Ability to provide written informed consent\n* Provide written approval by a qualified healthcare professional\n* Willing to be randomized\n\nExclusion Criteria:\n\n* Evidence of metastatic or recurrent colorectal cancer\n* Concurrently actively treated other (non-colorectal) cancer\n* Scheduled to receive other postoperative cancer-directed treatment(s)\n* Currently pregnant, breastfeeding, or planning to become pregnant within the next 24 weeks\n* Currently participating in another study with competing outcomes\n* Contraindications to magnetic resonance imaging\n* Any dietary condition or restriction that would limit tolerance of a mixed meal challenge\n* Any other cardiovascular, pulmonary, orthopedic, neurologic, psychiatric, or other condition that, in the investigator's opinion, would preclude participation or successful compliance with the protocol\n* Any other situation that, in the opinion of the investigator, would negatively impact subject safety or successful compliance with the protocol"}, 'identificationModule': {'nctId': 'NCT05789433', 'acronym': 'RESTORE', 'briefTitle': 'Effects of Aerobic Exercise on Skeletal Muscle Remodeling in Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'AdventHealth Translational Research Institute'}, 'officialTitle': 'Effects of Aerobic Exercise on Skeletal Muscle Remodeling in Colorectal Cancer', 'orgStudyIdInfo': {'id': 'PBRC 2022-014'}, 'secondaryIdInfos': [{'id': 'R01CA270274', 'link': 'https://reporter.nih.gov/quickSearch/R01CA270274', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Attention control', 'description': 'Static stretching', 'interventionNames': ['Behavioral: Progressive stretching']}, {'type': 'EXPERIMENTAL', 'label': 'Aerobic exercise', 'description': 'Aerobic exercise at a dose of 225 minutes per week', 'interventionNames': ['Behavioral: Aerobic exercise']}], 'interventions': [{'name': 'Aerobic exercise', 'type': 'BEHAVIORAL', 'description': 'Moderate- to vigorous-intensity aerobic exercise', 'armGroupLabels': ['Aerobic exercise']}, {'name': 'Progressive stretching', 'type': 'BEHAVIORAL', 'description': 'Statistic stretching of eight major muscle groups', 'armGroupLabels': ['Attention control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Justin C Brown, Ph.D.', 'role': 'CONTACT', 'email': 'Justin.Brown4@AdventHealth.com', 'phone': '4073035600'}], 'facility': 'AdventHealth', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'centralContacts': [{'name': 'Justin C. Brown, Ph.D.', 'role': 'CONTACT', 'email': 'Justin.Brown4@AdventHealth.com', 'phone': '407-303-5600'}], 'overallOfficials': [{'name': 'Justin C. Brown, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AdventHealth'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AdventHealth Translational Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Exercise & Cancer Biology Research Program', 'investigatorFullName': 'Justin Brown', 'investigatorAffiliation': 'AdventHealth Translational Research Institute'}}}}