[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"impaired-cognition\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:impaired-cognition":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100231453","chemotherapy-induced-cognitive-and-brain-changes-in-older-adults-with-breast-cancer-100231453",false,"NCT02290834","Chemotherapy-induced Cognitive and Brain Changes in Older Adults With Breast Cancer","Inclusion Criteria:\n\n* Breast cancer patients treated with chemotherapy- Group 1 (experimental group)\n\n  * Participants must meet the following criteria on screening examination to be eligible to participate in the behavioral +\u002F- imaging components of study\n  * New diagnosis histologically confirmed invasive breast cancer\n  * Treatment plan to include chemotherapy\n  * Female subjects age ≥ 60 years.\n  * Life expectancy ≥ 1 year\n  * Karnofsky Performance Score (KPS) ≥ 80\n  * Ability to understand and the willingness to sign a written informed consent document.\n* Non-treated breast cancer patient controls- Group 2 (control group)\n\n  * Participants must meet the following criteria on screening examination to be eligible to participate in the behavioral +\u002F- imaging components of study:\n  * New diagnosis histologically confirmed invasive breast cancer\n  * Treatment plan does not include chemotherapy\n  * Age ≥ 60 years.\n  * Life expectancy ≥ 1 year\n  * Karnofsky Performance Score (KPS) ≥ 80\n  * Ability to understand and the willingness to sign a written informed consent document.\n* Healthy control subjects- Group 3 (control group)\n\n  * Participants must meet the following criteria on screening examination to be eligible to participate in the behavioral +\u002F- imaging components of study:\n  * Age ≥ 60 years.\n  * Life expectancy ≥ 1 year\n  * Karnofsky Performance Score (KPS) ≥ 80\n  * Ability to understand and the willingness to sign a written informed consent document.\n  * Participants with well-controlled vascular risk factors, such as treated hypertension, treated hyperlipidemia or well-controlled Type II diabetes (glucose levels \\\u003C250) may be included.\n  * Serum Pregnancy Testing: STAT quantitative serum hCG pregnancy testing for all women of childbearing potential. Imaging will not start until and unless the test result returns negative.\n\nExclusion Criteria:\n\n* Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study:\n\n  * Participants with clinical or radiographic evidence of metastatic CNS disease\n  * Subjects with MMSE scores below 24\n  * Active or history of major psychiatric disorders such as schizophrenia, schizoaffective disorder, major affective disorder in mid-life, or treatment with ECT (Mild depression that is well treated with stable dose of SSRI antidepressants may be allowed).\n  * Substance abuse within the past 2 years\n  * Huntington's disease, hydrocephalus or seizure disorder\n* In addition to exclusion criteria above, participants who exhibit any of the following conditions at screening will not be eligible for admission into imaging portion of the study:\n\n  * Participants with contraindications to MRI (i.e., implanted metal including pacemakers, cerebral spinal fluid shunts, aneurysm clips, artificial heart valves, ear implants or metal\u002Fforeign objects in the eyes and those with a history of claustrophobia), injuries to the eyes with metal without X-ray documentation that metal was removed",true,"FEMALE","60 Years",{"count":19,"type":20},200,"ESTIMATED","INTERVENTIONAL",[23],"NA","This research study evaluates the effect of chemotherapy on cognition (thinking) and the brain in people with breast cancer.",[26,27,28],"Impaired Cognition","Chemo-brain","Breast Cancer",[30,27],"Chemotherapy related cognitive impairment","RECRUITING","2026-03-09",{"date":34,"type":35},"2026-03-11","ACTUAL",{"date":37,"type":4},"2015-03",{"date":39,"type":20},"2028-01",{"name":41,"class":42},"Massachusetts General Hospital","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100405196","simultaneous-recumbent-cycling-and-cognitive-training-100405196","NCT04556227","Simultaneous Recumbent Cycling and Cognitive Training","Simultaneous Recumbent Cycling and Cognitive Training on Cognition in Intensive Care Unit Survivors: a Randomized Control Trial","Inclusion Criteria:\n\n* Age 45-64 years\n* Admitted to medical or surgical ICUs (SLH \\& TMC) for \\>24 hours\n* English-speaking\n* Discharged home\n* Able to provide consent\n* Access to a telephone\n* One or more delirium episode in ICU (positive CAM-ICU).\n\nExclusion Criteria:\n\n* Cancer diagnosis with short life expectancy determined by the Primary Care Provider (unable to complete the study within time frame)\n* Chemotherapy (drug-induced impaired cognition)\n* Diagnosed vascular dementia or other neurodegenerative diseases (e.g. Alzheimer or Parkinson disease)\n* Documented alcohol consumption ≥5 drinks\u002Fday (withdrawal delirium tremens)\n* Corrected vision\\\u003C20\u002F80 Snellen chart (unable to do cognitive exercises on the tablet)\n* Examiner rated low hearing or communicative ability that would interfere with intervention and assessments\n* Positive CAM-ICU (delirium) at hospital discharge\n* Unable to participate in rehabilitation (abnormal 6 min walk test)\n* Any physical condition preventing recumbent cycling\n* Recent documented history of drug abuse.","ALL","45 Years","64 Years",{"count":54,"type":20},50,[23],"Intensive care units (ICU) provide life-saving care for nearly five million people annually. Up to 80% of patients receiving care in an ICU experience at least one episode of delirium. Delirium, an acute episodic display of confused thinking and unawareness, predicts impaired cognition and accelerated cognitive decline which negatively impacts quality of life (QOL) long after hospital discharge. The average age of ICU patients is 52 years. These middle-age (MA) ICU survivors need cognitive interventions that are well planned, accessible, and effective to improve cognition and prevent accelerated decline so they can resume their previous QOL and enter older age with optimized cognitive function. Physical exercise and cognitive training independently improve cognition and emerging evidence indicates that combining these two approaches produces even greater effects on cognition. Community-based rehabilitation centers are accessible for MAICU survivors to engage in physical activity; cognitive training could easily be added. Approaches in which a patient engages in physical exercise and cognitive training concurrently is an understudied intervention for all ICU survivors, especially those who are middle-aged. Study aims are to investigate the feasibility and acceptability of a simultaneous recumbent cycling and cognitive training intervention (SRCCT) for MAICU survivors who experienced at least one delirium episode during their ICU stay. Feasibility will be determined by systematically evaluating research team training, participant recruitment, randomization, implementation, and intervention fidelity. Acceptability will be evaluated via a satisfaction, preferences, burden, and participant-suggested improvements survey. The SRCCT effect sizes will be calculated comparing multiple data point cognition scores between an SRCCT group and a usual care control group. Upon completion, investigators expect to understand the feasibility and acceptability of the SRCCT delivered in community-based rehabilitation centers, and the combined effect of SRCCT on cognition and QOL for middle-aged ICU survivors who experienced an episode of ICU delirium. The hypothesis is that study participants who engage in physical exercise and cognitive training concurrently will have a greater improvement in cognition and QOL than physical exercise training alone.",[58,26],"Delirium",[60,61,62,63,64],"Intensive Care Unit","ICU-Survivors","Cognitive Training","Recumbent Cycling","Executive Functioning","2024-12-03",{"date":67,"type":35},"2024-12-06",{"date":65,"type":20},{"date":70,"type":20},"2025-12-31",{"name":72,"class":42},"University of Missouri, Kansas City",1]