Ignite Creation Date:
2025-12-24 @ 2:34 PM
Ignite Modification Date:
2025-12-26 @ 1:02 PM
Study NCT ID:
NCT07224659
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-05
First Post:
2025-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise and Mortality in Middle-Aged and Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 19000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-08-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-02', 'studyFirstSubmitDate': '2025-11-02', 'studyFirstSubmitQcDate': '2025-11-02', 'lastUpdatePostDateStruct': {'date': '2025-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-08-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exploratory Analyses #1', 'timeFrame': 'up to 19 years', 'description': 'Analyses to examine whether the association between exercise vs. control with all-cause mortality differs as a function of:\n\n* Sex (male vs. female)\n* Age (\\<50 years vs. =/\\>50 years)'}, {'measure': 'Exploratory Analyses #2', 'timeFrame': 'up to 19 years', 'description': 'Examine the association between exercise vs. control with incidence of individual cancer types.'}], 'primaryOutcomes': [{'measure': 'Overall survival (all-cause mortality)', 'timeFrame': 'up to 19 years', 'description': 'All-cause mortality (death from any cause) occurring within the follow-up period in the PLCO screening trial.'}, {'measure': 'Cause-specific mortality', 'timeFrame': 'up to 19 years', 'description': 'Cause-specific mortality (cancer mortality, mortality from other causes) occurring within the total follow-up period in the PLCO screening trial.'}], 'secondaryOutcomes': [{'measure': 'Cancer incidence', 'timeFrame': 'up to 19 years', 'description': 'Cancer incidence occurring within the total follow-up period in the PLCO screening trial.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overall Survival (All-cause Mortality)']}, 'descriptionModule': {'briefSummary': "This protocol is a retrospective study using the observational data of the the Prostate, Lung, Colorectal, and Ovarian (PLCO) screening trial with over 150,000 participants aged 55-74 years to conduct a target trial emulation to examine the association between self-reported exercise and all cause and cause-specific mortality in apparently healthy, middle-aged and older adults. The PLCO includes assessments of participants' exercise level at two timepoints: at randomization into the PLCO trial (Q0) and 5-7 years after randomization into the PLCO (Q1)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '55 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults enrolled into the PLCO screening trial', 'healthyVolunteers': False, 'eligibilityCriteria': '* Adults enrolled into the PLCO screening trial.\n* Among participants reporting low exercise at Q0 (i.e., 0 or less than 1 day/week, with each session \\<15 minutes in duration), completion of an exercise survey at Q1 as part of PLCO standard trial procedures no later than 5 years after reporting non-exercising status \\[i.e., no exercise) at Q0.\n* No evidence of any of the following absolute contraindications to exercise: uncontrolled hypertension, symptomatic valvular disease; hypertrophic cardiomyopathy; unstable angina pectoris; primary pulmonary hypertension; heart failure; severe arrhythmia; diagnosed dementia; any form of cancer other than non-melanoma, and severe infectious disease.'}, 'identificationModule': {'nctId': 'NCT07224659', 'briefTitle': 'Exercise and Mortality in Middle-Aged and Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'City of Hope Medical Center'}, 'officialTitle': 'Exercise and Mortality in Middle-Aged and Older Adults: A Target Trial Emulation', 'orgStudyIdInfo': {'id': '25603'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Arm 1 - Control', 'description': '0 or less than 1 day per week, with each session, on average \\< 15 minutes.', 'interventionNames': ['Behavioral: Control']}, {'label': 'Arm 2 - Exercise', 'description': '\\>/= 2 days per week of moderate or vigorous intensity, with each session, on average, \\>/=20 minutes in duration.', 'interventionNames': ['Behavioral: Exercise']}], 'interventions': [{'name': 'Control', 'type': 'BEHAVIORAL', 'description': '0 or less than 1 day per week, with each session, on average \\< 15 minutes.', 'armGroupLabels': ['Arm 1 - Control']}, {'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': '\\>/= 2 days per week of moderate or vigorous intensity, with each session, on average, \\>/=20 minutes in duration.', 'armGroupLabels': ['Arm 2 - Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}], 'centralContacts': [{'name': 'Lee W Jones, PhD', 'role': 'CONTACT', 'email': 'leejones@coh.org', 'phone': '626-218-3844'}, {'name': 'Lennie Wong, PhD', 'role': 'CONTACT', 'email': 'lenniewong@coh.org', 'phone': '626-218-3844'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'City of Hope Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}