[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06434168":3,"trial-entities:NCT06434168":87,"trial-summary:NCT06434168":91},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":40,"secondary_outcomes":54,"sex":55,"minimum_age":56,"maximum_age":57,"healthy_volunteers":15,"eligibility_criteria":58,"std_ages":71,"locations":74,"central_contacts":83,"overall_officials":84,"references":85,"see_also_links":86},"NCT06434168","AU-24-001","Impact of Yoga on Cognitive Function","A Pilot and Feasibility Study of a Yoga Intervention in Heart Failure Patients With Mild Cognitive Impairment","ENROLLING_BY_INVITATION","2027-12-31","2025-09","2026-04-06","2024-07-16","Auburn University","OTHER",false,"Mild cognitive impairment is highly prevalent in patients with heart failure and results in poor well-being and quality of life. While yoga has proven effective in promoting cognitive health in older adults through its gentle movements, controlled breathing, and meditation, its effects on patients with heart failure remain unknown. Therefore, this feasibility and pilot study plans to deliver a 12-week yoga intervention and test its effects on cognitive function in patients with heart failure and mild cognitive impairment.","A prospective, 2-arm comparative feasibility design will be used. The investigators will enroll 24 patients with a confirmed heart failure diagnosis with mild cognitive impairment. Patients will be randomized equally into yoga intervention or control group. Patients in the yoga intervention group will receive a 60-minute yoga session twice per week for 12-week. Survey, cognitive function data, MRI scans, and blood samples will be collected at baseline and at 3 months (after completion of yoga intervention).",[19,20],"Heart Failure","Mild Cognitive Impairment",[22,23],"Yoga intervention","cognitive function","INTERVENTIONAL","PREVENTION",[27],"NA",{"count":29,"type":30},24,"ESTIMATED",[32,36],{"type":33,"name":22,"description":34,"armGroupLabels":35},"BEHAVIORAL","Patients in the yoga group will receive a 60-minute session, twice per week over 12 weeks for a total of 24 sessions. Each yoga session consists of a warm-up, yoga postures standing or seated depending on the capability of the patient, and relaxation.",[22],{"type":33,"name":37,"description":38,"armGroupLabels":39},"Control condition","Patients in the control group will receive care-as-usual from their healthcare providers and will be asked to avoid engaging in yoga during their 3 months in the study.",[37],[41,45,48,51],{"measure":42,"description":43,"timeFrame":44},"Brain structure","Using structural magnetic resonance imaging to examine brain structure between intervention and control groups. Less brain alteration is optimal.","Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention",{"measure":46,"description":47,"timeFrame":44},"Brain functional connectivity","Functional magnetic resonance imaging is used to examine functional connectivity between intervention and control groups. A balance of activity across different brain regions is optimal.",{"measure":49,"description":50,"timeFrame":44},"Cognitive function","Using cognitive tests to examine cognitive function and performance between intervention and control groups. A higher score on cognitive tests indicates better cognitive function.",{"measure":52,"description":53,"timeFrame":44},"Serum brain-derived neurotrophic factor","A blood sample will be obtained using phlebotomy to measure the levels of serum brain-derived neurotrophic factor and reported in pg\u002FmL. Higher concentrations are optimal.",[],"ALL","55 Years","70 Years",{"inclusion":59,"exclusion":63,"raw_text":70},[60,61,62],"Aged 55 years and older","Confirmed heart failure diagnosis with mild cognitive impairment","New York Heart Association functional class II-IV",[64,65,66,67,68,69],"Co-existing neurological disorders, traumatic brain injury, psychiatric disorders, or terminal illnesses","Have implanted defibrillator, left ventricular assist device placement or cardiac transplant","Have any other implanted metals that interfere with the MRI magnetic field for patient safety","Substance abuse","Pregnant","Unable to perform yoga due to physical limitations or severity of illness","Inclusion Criteria:\n\n* Aged 55 years and older\n* Confirmed heart failure diagnosis with mild cognitive impairment\n* New York Heart Association functional class II-IV\n\nExclusion Criteria:\n\n* Co-existing neurological disorders, traumatic brain injury, psychiatric disorders, or terminal illnesses\n* Have implanted defibrillator, left ventricular assist device placement or cardiac transplant\n* Have any other implanted metals that interfere with the MRI magnetic field for patient safety\n* Substance abuse\n* Pregnant\n* Unable to perform yoga due to physical limitations or severity of illness",[72,73],"ADULT","OLDER_ADULT",[75],{"facility":13,"city":76,"state":77,"zip":78,"country":79,"geoPoint":80},"Auburn","Alabama","36849","United States",{"lat":81,"lon":82},32.60986,-85.48078,[],[],[],[],{"nct_id":4,"conditions":88,"biomarkers":90},[19,89],"Mild cognitive disorder",[],{"nct_id":4,"found":15,"summary":92,"prompt_version":92},null]