[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06476288":3,"trial-entities:NCT06476288":109,"trial-summary:NCT06476288":115},{"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":22,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":51,"secondary_outcomes":65,"sex":84,"minimum_age":85,"maximum_age":17,"healthy_volunteers":86,"eligibility_criteria":87,"std_ages":91,"locations":93,"central_contacts":102,"overall_officials":103,"references":107,"see_also_links":108},"NCT06476288","Pro00115014","RIC (Remote Ischemic Conditioning) in Older Individuals","Feasibility and Acceptability of Remote Ischemic Conditioning to Achieve High-Intensity Rehabilitation Effects and Increase Resilience in Older Individuals","ENROLLING_BY_INVITATION","2026-12","2026-07","2026-07-08","2024-09-30","Duke University","OTHER",true,"The purpose of this study is to examine the feasibility and acceptability of a technique called remote ischemic conditioning (RIC) that aims to improve muscle strength, muscle mass, exercise tolerance, resilience (i.e. how well someone responds to a stressor), quality of life, physical activity, and physical function when added to rehabilitative exercise training in individuals over age 65 who have some difficulty with mobility.",null,[19,20,21],"Old Age","Mobility Limitation","Debility",[23,24,25,26,27,28],"Exercise","Strength training","Conditioning","RIC","Remote Ischemic Conditioning","Ischemic Conditioning","INTERVENTIONAL","SUPPORTIVE_CARE",[32],"NA",{"count":34,"type":35},20,"ESTIMATED",[37,43,47],{"type":14,"name":38,"description":39,"armGroupLabels":40},"Low-intensity resistance exercise training","The intervention protocol will consist of 60 minutes of low-intensity resistance exercise training 3x\u002Fweek for 6 weeks.",[41,42],"High-Dose RIC (Remote Ischemic Conditioning) Intervention","Low-Dose RIC Intervention",{"type":14,"name":44,"description":45,"armGroupLabels":46},"High-Dose Remote ischemic conditioning (RIC)","Treatment dose of RIC- the RIC cuff will be inflated to 20 mmHg over the participant's systolic blood pressure. The treatment dose of RIC will be applied in 4 sets of cycles with inflating the cuff and leaving it pumped for 5 minutes then deflating the cuff for an off period of 5 minutes. Total treatment time will be 35 minutes.",[41],{"type":14,"name":48,"description":49,"armGroupLabels":50},"Low-Dose Remote ischemic conditioning (RIC)","This dose will be the control for the study. Low-dose RIC- the RIC cuff will be inflated to 10 mmHg below the participant's diastolic blood pressure. The low-dose RIC will be applied in 4 sets of cycles with inflating the cuff and leaving it pumped for 5 minutes then deflating the cuff for an off period of 5 minutes. Total treatment time will be 35 minutes.",[42],[52,55,58,60,62],{"measure":53,"timeFrame":54},"Feasibility of study intervention as measured by the number of participants who completed the study","Up to 6 weeks",{"measure":56,"description":57,"timeFrame":54},"Feasibility of study intervention as measured by the attrition rate","Attrition rate is expressed as a percentage and is calculated by dividing the number of non-completers by the total number of participants.",{"measure":59,"timeFrame":54},"Feasibility of study intervention as measured by the number of exercise visits attended per participant",{"measure":61,"timeFrame":54},"Feasibility of study intervention as measured by the number of RIC home applications completed per participant",{"measure":63,"description":64,"timeFrame":54},"Acceptability of study intervention as measured by an Intervention Acceptability Questionnaire","Each participant will complete an Intervention Acceptability Questionnaire with responses on a 5-point Likert scale, where a higher score indicates greater acceptability.",[66,68,72,75,77,79,82],{"measure":67,"timeFrame":54},"Feasibility of collecting blood samples during study as measured by the success rate of collection",{"measure":69,"description":70,"timeFrame":71},"Change in Short Physical Performance Battery (SPPB)","The SPPB measures changes in physical function.","Baseline to post-intervention visit (approximately 7 weeks)",{"measure":73,"description":74,"timeFrame":71},"Change in muscle strength as measured by dynamometry","Measurements made with isokinetic dynamometry, hand-held dynamometry and DXA scans completed at pre- and post-intervention.",{"measure":76,"timeFrame":71},"Change in exercise tolerance as measured by VO2peak testing",{"measure":78,"timeFrame":71},"Change in quality of life as measured by PROMIS-29",{"measure":80,"description":81,"timeFrame":71},"Change in Brief Resilience 5-point Likert Scale","Higher score indicates greater resilience.",{"measure":83,"timeFrame":71},"Change in vascular function as measured by arterial tonometry","ALL","65 Years",false,{"inclusion":88,"exclusion":89,"raw_text":90},[],[],"Inclusion Criteria:\n\n1. Age: ≥ 65 years and referred to an exercise program for functional decline, deconditioning, or fall risk\n2. Exercises ≤ 2x\u002Fweek on a regular interval\n\nExclusion Criteria:\n\n1. Unstable heart disease as determined by the investigator or study physician\n2. History of any orthopaedic, neurologic, or metabolic condition that would contraindicate exercise testing\u002Ftraining as determined by the investigator\n3. Cognitive inability to follow directions and safely participate in exercise",[92],"OLDER_ADULT",[94],{"facility":13,"city":95,"state":96,"zip":97,"country":98,"geoPoint":99},"Durham","North Carolina","27710","United States",{"lat":100,"lon":101},35.99403,-78.89862,[],[104],{"name":105,"affiliation":13,"role":106},"W Todd Cade, PhD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":110,"biomarkers":114},[111,112,113,20],"At increased risk for falls","Deconditioning","Functional Decline",[],{"nct_id":4,"found":86,"summary":17,"prompt_version":17}]