[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053516":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":31,"locations":37,"responsibleParty":56,"collaborators":58,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":18,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":18,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":86,"whyStopped":18,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"The University of Texas Health Science Center at San Antonio","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SwallowFit Intervention","EXPERIMENTAL","Subjects randomized to intervention will receive 6-weeks of twice weekly SwallowFIT per protocol (1-hour session each day). The program begins with provision of general education on swallowing and swallowing change from the Parkinson's Foundation and Michael J Fox association websites. Following this the program trains a modified effortful swallow technique at its onset using surface electromyographic (sEMG) biofeedback to guide the development of better swallow movement form, effort and performance. From there it applies a hierarchy of swallowing exercises\u002Ftasks involving swallowing food\u002Ffluid materials at different complexity levels (swallow specificity) to stimulate and train progressive resistance and leverage variability of coordinated speeded actions.",[13],"Behavioral: SwallowFit",{"label":15,"type":16,"description":17,"interventionNames":18},"Clinical Monitoring Only (CMO)","NO_INTERVENTION","CMO intervention reflects current swallow management practice for PD, where physicians monitor clinical function in swallowing and other related symptomology, referring for swallowing treatment only if an obvious issue has been identified. Subjects randomized to CMO will also receive general education on swallowing and swallow changes from the Parkinson's Foundation and Michael J Fox association websites.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","SwallowFit","The SwallowFIT protocol follows an increasing task difficulty (levels on the hierarchy) and motor learning strategy. Progression on the hierarchy is guided and monitored by the occurrence of inefficiency markers in swallow wing (e.g. excessive lingual pumping, swallow hesitation, throat clearing etc.) confirmed from the baseline clinical and video fluoroscopic evaluations.",[9],[26],"Swallowing exercises",[28],{"name":29,"affiliation":5,"role":30},"Giselle Carnaby, PhD, MP","PRINCIPAL_INVESTIGATOR",[32],{"name":33,"role":34,"phone":35,"phoneExt":18,"email":36},"Giselle Carnaby, PhD, MPH","CONTACT","210-450-7130","carnaby@uthscsa.edu",[38],{"facility":39,"status":18,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Brooke Army Medical Center (BAMC)","San Antonio","Texas","78234-6200","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-98.49363,29.42412,{"lat":49,"lon":48},[52,53],{"name":33,"role":34,"phone":35,"phoneExt":18,"email":36},{"name":54,"role":34,"phone":55,"phoneExt":18,"email":18},"Alexis Nelson","210-916-2203.",{"type":57,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[59],{"name":60,"class":61},"United States Department of Defense","FED","100053516","swallowfit-study-in-parkinsons-disease-100053516",false,"NCT07356414","SwallowFIT Study in Parkinson's Disease","\"SwallowFit,\" an Exercise Program and Randomized Clinical Trial Designed for US Service Members, Veterans, and Families Affected by Parkinson's Disease.","Inclusion Criteria:\n\n1. Adult S-VWP between \\>35-90 years of age\n2. Diagnosis of Idiopathic Parkinson's Disease \\[IDP\\] (either or suspected, tremor-predominant or rigid predominant)\n3. Disability level of Hoehn \\& Yahr stages II-III as indicated in their most recent neurological evaluation\n4. Swallowing concern, confirmed by Modified Unified Parkinson Disease Rating Scale \\[MDS-UPDRS\\]-\n5. ADL swallowing item \\>0, or Mann Assessment of Swallowing scale \\[MASA\\] score ≤185.\n6. Able to consume oral nutrition \\[Functional Oral Intake Score ≤ 6\\]\n7. Ambulatory\n8. No change of medication for at least 4 weeks before study inclusion\n\nExclusion Criteria:\n\n1. Classified as Hoehn and Yahr stages IV\n2. Unable to follow 2 step commands\n3. History of other neurological disease potentially causing dysphagia\n4. Dementia (MMSE\\\u003C20; Montreal cognitive assessment (MoCA) ≤ 20)\n5. Severe depression (BDI\\>19)\n6. Severe dyskinesia of head and neck (resulting in problems with MBSS recording)\n7. Severe documented Gastrointestinal disease\n8. History of Gastro-esophageal surgery\n9. History of Head or neck cancer with swallowing impairment or surgical intervention\n10. History of breathing disorders or diseases (e.g., Asthma, chronic obstructive pulmonary disease (COPD) requiring assistive breathing support.\n11. Untreated hypertension\n12. Heart disease requiring restricted activity and medical intervention\n13. Speech therapy intervention for swallowing within the past three months\n14. Women who are pregnant, nursing, or who plan to become pregnant during the study","ALL","35 Years","90 Years",{"count":73,"type":74},80,"ESTIMATED","INTERVENTIONAL",[77],"NA","The goal of this clinical trial is to learn if a proactive swallow exercise will help to improve swallow fitness in patients with Parkinson's disease.\n\nThe aim of the study is to assess how effective this exercise is and to measure the change in swallowing fitness from the beginning to the end of the study.\n\nPatients who are given the exercise training will be compared to participants who are treated using the usual standard treatment.\n\nPatients will have 6 weeks of twice-weekly SwallowFIT training. Each session will be an hour long.",[80],"PARKINSON DISEASE (Disorder)",[82,83,84,85],"Swallowing","US Service members","Veterans","SwallowFIT","NOT_YET_RECRUITING","2026-07-09",{"date":89,"type":90},"2026-07-13","ACTUAL",{"date":92,"type":74},"2026-08-30",{"date":94,"type":74},"2028-06-29",{"name":5,"class":6},1]