[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"physical-impairment\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:physical-impairment":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":33,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100609792","early-phase-1-kava-aging-and-mobility-study-100609792",false,"NCT07219186","Kava Aging and Mobility Study","Impacts of AB-free Kava on Mitigating Mobility Loss With Aging: A Pilot Study","Inclusion Criteria:\n\n* Age \\> 70 years\n* 8 ≤ Insomnia severity index (ISI) ≤21\n* 4m walking speed \\\u003C1 m\u002Fsec and \\>0.44 m\u002Fsec\n* Mild to moderate physical impairment (Short Physical Performance Battery score \\\u003C 10)\n* Sedentary lifestyle (\\\u003C 150 min per week of moderate intensity physical activity) verified by CHAMPS questionnaire\n* Willingness and ability to give informed consent\n* Willingness to be randomized to the intervention groups\n* Availability for participation through duration of study Exclusion Criteria (General)\n* Failure to provide informed consent\n* History or clinical manifestation of diabetes, cholelithiasis, liver or renal disease, cancer, or progressive, degenerative neurologic disease (e.g., Parkinson's Disease, multiple sclerosis, ALS)\n* Abnormal laboratory markers (e.g., renal or liver abnormalities, elevated potassium levels, or hemoglobin and hematocrit below the lower limit of normal)\n* Residence in a Skilled Nursing Facility (SNF); residence in an Assisted Living Facility (ALF) or independent housing is allowed\n* Self-reported inability to walk one block\n* Significant cognitive impairment, defined as a known diagnosis of dementia or a Mini-Mental Status Exam score \\\u003C 24\n* Severe rheumatologic or orthopedic diseases (e.g., awaiting joint replacement, active inflammatory disease)\n* Terminal illness with life expectancy less than 12 months, as determined by a physician\n* Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina\n* Severe pulmonary disease, pneumonitis or interstitial lung disease\n* Other significant co-morbid disease (e.g. renal failure on hemodialysis) or severe psychiatric disorder (e.g. bipolar, schizophrenia)\n* Current use of antidepressant medications, antipsychotic agents, monoamine oxidase inhibitors, anticholinesterase inhibitors (i.e., Aricept)\n* Refuses to reduce alcohol use to 3 or fewer alcoholic drinks per week during the study\n* Planning to permanently leave the area in the next year\n* Blood pressure readings \\>180\u002F100 at screening\n* Participating in another clinical trial or has received an investigational product within 30 days prior to screening\u002Fenrollment.\n\nExclusion Criteria (AB-free kava-related)\n\n* Regular use of any medications that contain acetaminophen\n* Current use of any forms of kava and not willing to stop for a 2-week washout period - dietary supplements or beverages\n* Current use of antidepressant medications and antipsychotic agents (including monoamine oxidase inhibitors), or anticholinesterase inhibitors (i.e., Aricept)\n* Diagnosed with liver dysfunction or with previous liver diseases during the past five years\n* Levels of ALT, AST, ALP or total bilirubin over 3xlimit of normal (ULN) range at prescreen\n\nTemporary Exclusion Criteria\n\n* Acute infection (urinary, respiratory, other) or hospitalization within 1 month\n* Myocardial infarction, CABG, or valve replacement within past 6 months\n* Pulmonary embolism or deep venous thrombosis within past 6 months\n* Stroke, hip fracture, hip or knee replacement, or spinal surgery within past 4 months\n* Receiving physical therapy for gait, balance, or other lower extremity training","ALL","70 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","The goal of this clinical trial is to learn if AB-free kava works to improve mobility and physical function in older adults with sleep difficulties. It will also learn about the safety of AB-free kava. The main questions it aims to answer are:\n\n* Does AB-free kava improve physical function and\u002For mobility?\n* Does AB-free kava effect sleep, stress, or cellular signaling? Researchers will compare AB-free kava to a placebo (a look-alike substance that contains no drug) to see if AB-free kava works to improve mobility and physical functioning.",[26,27,28,29,30,31,32],"Old Adults","Sleep Quality","Kava","Mobility Impairment","Physical Activity and Stress","Physical Impairment","Sedentary Lifestyle in Patients Over 70",[34,35,36,37],"AB-free Kava","Old adults","Sleep Difficulties","Mobility Limitations","NOT_YET_RECRUITING","2026-01-30",{"date":41,"type":42},"2026-02-02","ACTUAL",{"date":44,"type":20},"2026-04",{"date":46,"type":20},"2027-05",{"name":48,"class":49},"University of Florida","OTHER",2]