[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06823921":3,"trial-entities:NCT06823921":87,"trial-summary:NCT06823921":90},{"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":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":40,"secondary_outcomes":45,"sex":52,"minimum_age":53,"maximum_age":54,"healthy_volunteers":15,"eligibility_criteria":55,"std_ages":66,"locations":69,"central_contacts":79,"overall_officials":80,"references":81,"see_also_links":86},"NCT06823921","2000039232","Cognitive Effects of Exercise in Parkinson's Disease","Effects of High-Intensity Interval Training (HIIT) on Cognitive Function and Quality of Life in Parkinson's Disease: A Pilot Clinical Trial","ENROLLING_BY_INVITATION","2027-03-01","2026-01","2026-02-03","2025-02-11","Sule Tinaz","OTHER",false,"This pilot study will evaluate the short-term (3 months) and long-term (6 months) effectiveness of a high-intensity interval training (HIIT) program in improving cognitive function and self-efficacy in individuals with PD.","Participants will be assigned to either the HIIT group, which will engage in 3 classes per week, or a standard-of-care control group, which will include people who will continue their standard care and usual physical activities but do not plan on partaking in additional structured exercise interventions for 3 months (except for physical and occupational therapy if medically necessary). Cognitive functions will be measured using standardized tests (Stroop, Trail Making Test-B (TMT-B), verbal fluency (using letters F-A-S), and Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)), alongside assessing subjective ratings of daily cognitive function using the Neuro Quality of Life - Cognitive Function (Neuro-QoL CF) survey. Secondary outcomes will include self-efficacy measures, specifically regarding goal achievement, managing emotions and daily activities. We will also aim to obtain brain functional MRI (fMRI) and neuromelanin-sensitive MRI (NM-MRI) data from a subset of participants to measure the brain effects of HIIT as exploratory outcomes.",[19],"Parkinson Disease",[21,22,23,24],"exercise","high-intensity interval training","cognitive function","MRI","INTERVENTIONAL","TREATMENT",[28],"NA",{"count":30,"type":31},30,"ESTIMATED",[33],{"type":14,"name":34,"description":35,"armGroupLabels":36,"otherNames":38},"Exercise","HIIT will include aerobic, strength, and balance exercises and boxing",[37],"High-intensity interval training",[39],"HIIT",[41],{"measure":42,"description":43,"timeFrame":44},"Quality of Life in Neurological Disorders (Neuro-QoL) cognitive function survey","Subjective measures of cognitive functioning in daily life. It captures aspects of cognitive functioning such as attention, memory, and executive function. The average T-score is 50. Higher score indicates better performance.","3 months and 6 months",[46,49],{"measure":47,"description":48,"timeFrame":44},"Executive function composite T-score","Average T-scores of Trail Making Test-B, Stroop, and F-A-S verbal fluency test that are used to test executive functions. The average T-score is 50. Higher score indicates better performance.",{"measure":50,"description":51,"timeFrame":44},"Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) memory domain index score","Examines verbal and visual memory performance and calculates an index score (range: 40-160). Higher score indicates better performance.","ALL","40 Years",null,{"inclusion":56,"exclusion":60,"raw_text":65},[57,58,59],"Diagnosis of idiopathic Parkinson's disease","Age 40 year and above","Willingness and ability to participate in HIIT exercise classes",[61,62,63,64],"Non-English speaking","Neuropsychiatric disorder other than Parkinson's disease and comorbid depression and anxiety (e.g., stroke, epilepsy, brain tumor, multiple sclerosis, schizophrenia, bipolar disorder, obsessive compulsive disorder, etc.)","High levels of exercise at baseline (exercising at high intensity at least 3 times per week or moderate intensity at least 5 times per week)","Hoehn \\& Yahr disease stage \\> 3 (physically not independent)","Inclusion Criteria:\n\n* Diagnosis of idiopathic Parkinson's disease\n* Age 40 year and above\n* Willingness and ability to participate in HIIT exercise classes\n\nExclusion Criteria:\n\n* Non-English speaking\n* Neuropsychiatric disorder other than Parkinson's disease and comorbid depression and anxiety (e.g., stroke, epilepsy, brain tumor, multiple sclerosis, schizophrenia, bipolar disorder, obsessive compulsive disorder, etc.)\n* High levels of exercise at baseline (exercising at high intensity at least 3 times per week or moderate intensity at least 5 times per week)\n* Hoehn \\& Yahr disease stage \\> 3 (physically not independent)",[67,68],"ADULT","OLDER_ADULT",[70],{"facility":71,"city":72,"state":73,"zip":74,"country":75,"geoPoint":76},"Yale University","New Haven","Connecticut","06519","United States",{"lat":77,"lon":78},41.30815,-72.92816,[],[],[82],{"pmid":83,"type":84,"citation":85},"38336768","RESULT","de Laat B, Hoye J, Stanley G, Hespeler M, Ligi J, Mohan V, Wooten DW, Zhang X, Nguyen TD, Key J, Colonna G, Huang Y, Nabulsi N, Patel A, Matuskey D, Morris ED, Tinaz S. Intense exercise increases dopamine transporter and neuromelanin concentrations in the substantia nigra in Parkinson's disease. NPJ Parkinsons Dis. 2024 Feb 9;10(1):34. doi: 10.1038\u002Fs41531-024-00641-1.",[],{"nct_id":4,"conditions":88,"biomarkers":89},[19],[],{"nct_id":4,"found":15,"summary":54,"prompt_version":54}]