[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623395":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":83,"collaborators":25,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":87,"sex":93,"minAge":94,"maxAge":25,"enrollmentInfo":95,"targetDuration":25,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":108,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Xuanwu Hospital, Beijing","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PHYSIO-Prehab group","EXPERIMENTAL","The intervention group will receive a 6-week PHYSIO-Prehab multimodal prehabilitation program care. It includes 3 biweekly supervised group sessions and home-based multicomponent exercise. Additional interventions cover nutritional optimization, comorbidity management (targeting anemia, hypertension, and diabetes), and cognitive prehabilitation with brain protection measures.\n\nBoth groups will receive consistent perioperative ERAS care implemented by the orthopedic department since January 2019, including multimodal and preemptive analgesia, inspiratory muscle training, minimal intravenous fluid administration, early urinary tube removal, avoidance of mechanical bowel preparation, no prolonged fasting, and antithrombotic prophylaxis",[13],"Other: Multimodal physiological reserve optimizing prehabilitation program",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual care group","ACTIVE_COMPARATOR","Participants in the group will receive standard care per the enhanced recovery protocol for lumbar fusion in older adults, including pre-admission health education on smoking\u002Fexcessive drinking cessation, optimization of severe comorbidities, and general nutritional education.",[19],"Other: Usual Care",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Multimodal physiological reserve optimizing prehabilitation program","The PHYSIO-Prehab program features targeted multimodality integration, addressing the unmet need for surgery-specific preoperative interventions in elderly lumbar fusion patients. Its innovations lie in three aspects: first, it combines supervised group sessions with home-based exercise, balancing professional guidance and practical feasibility, and adjusts intensity via the Borg 10-point scale to fit individual tolerance. Second, it goes beyond conventional prehabilitation by integrating nutritional optimization, comorbidity management and cognitive prehabilitation, targeting physiological reserve deficits and frailty-related risks. Third, it is tailored to lumbar spinal disease characteristics, optimizing exercise modalities to avoid lumbar burden, which overcomes the limitations of general frailty interventions and enhances relevance to surgical recovery needs.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Usual Care","Both groups will receive consistent perioperative ERAS care implemented by the orthopedic department since January 2019, including multimodal and preemptive analgesia, inspiratory muscle training, minimal intravenous fluid administration, early urinary tube removal, avoidance of mechanical bowel preparation, no prolonged fasting, and antithrombotic prophylaxis.",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Shuaikang Wang, MD","CONTACT","15804084262","jackwangDR@163.com",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},"Shibao Lu, Ph.D., MD","18301680586","2984335856@163.com",[41,58,67,75],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Xuanwu hospital, Capital Medical University","RECRUITING","Beijing","Beijing Municipality","10053","China","CN",{"type":50,"coordinates":51},"Point",[52,53],116.39723,39.9075,{"lat":53,"lon":52},[56],{"name":57,"role":33,"phone":34,"phoneExt":25,"email":35},"Shuaikang Wang",{"facility":59,"status":43,"city":44,"state":25,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":60,"geoPoint":62,"contacts":63},"Beijing Friendship Hospital of Capital Medical University",{"type":50,"coordinates":61},[52,53],{"lat":53,"lon":52},[64],{"name":65,"role":33,"phone":38,"phoneExt":25,"email":66},"Zhong-En Li","2984335856@qq.com",{"facility":68,"status":43,"city":44,"state":25,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":69,"geoPoint":71,"contacts":72},"Department of Orthopedics, the Seventh Mecical Center of PLA General Hospital",{"type":50,"coordinates":70},[52,53],{"lat":53,"lon":52},[73],{"name":74,"role":33,"phone":25,"phoneExt":25,"email":25},"Yang Zhao",{"facility":76,"status":43,"city":44,"state":25,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":77,"geoPoint":79,"contacts":80},"Peking University First Hospital",{"type":50,"coordinates":78},[52,53],{"lat":53,"lon":52},[81],{"name":82,"role":33,"phone":25,"phoneExt":25,"email":25},"Yao Zhao",{"type":84,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100623395","pre-operative-risk-assessment-combined-with-targeted-intervention-in-the-chinese-elderly-with-spine-surgery-ii-100623395",false,"NCT07396077","Pre-operative Risk Assessment Combined With Targeted Intervention in the Chinese Elderly With Spine Surgery II","Multimodal Physiological Reserve Optimizing Prehabilitation Program (PHYSIO-Prehab) in the Chinese Elderly With Spine Surgery","PRACTICE-2","Inclusion Criteria:\n\n1. Aged ≥75 years at the time of screening\n2. Voluntarily sign the informed consent form\n3. Clinically diagnosed with degenerative lumbar spinal disorders with duration of symptoms \\>6 months\n4. Requiring elective lumbar fusion surgery (single-level or multi-level, open or minimally invasive approach)\n5. No severe cognitive impairment (Mini-Mental State Examination score \\> 9)\n6. Scheduled to undergo surgery within 6-8 weeks after screening (allowing completion of the 6-week prehabilitation program)\n\nExclusion Criteria:\n\n1. Scheduled to undergo other emergency surgery or day surgery\n2. Urgent medical conditions requiring priority management before spinal surgery\n3. With spinal disorders other than degenerative diseases (spinal fracture, tumor, metastasis, infection, ankylosing spondylitis, scoliosis with Cobb angle \\>40°)\n4. With contraindications to prehabilitation exercise (New York Heart Association Class IV heart failure, unstable angina, uncontrolled hypertension \\[systolic BP ≥180 mmHg or diastolic BP ≥110 mmHg despite medication\\])\n5. With severe functional disability for other disorders or long-term bedridden status unable to perform basic physical activities\n6. With allergy or intolerance to nutritional supplements used in the prehabilitation program\n7. Participating in another clinical trial involving prehabilitation, perioperative intervention, or spinal surgery within 3 months before screening","ALL","75 Years",{"count":96,"type":97},248,"ESTIMATED","INTERVENTIONAL",[100],"NA","This multicenter, parallel-group, assessor-blinded randomized controlled trial will enroll 248 adults aged ≥75 years with degenerative lumbar spinal diseases scheduled for elective lumbar fusion surgery, and they will be randomized 1:1 into the intervention and usual care groups. The intervention group will receive a 6-week PHYSIO-Prehab multimodal prehabilitation program, including multicomponent exercise, nutritional intervention, comorbidity optimization, and cognitive prehabilitation with brain protection strategies. The control group will receive standard health education provided via a manual, and both groups will receive consistent perioperative Enhanced Recovery After Surgery care. The primary outcome will be the change in Barthel Index (a tool for assessing independence in activities of daily living) from baseline to 30 days postoperatively; secondary outcomes will include pain scores, disability, patient satisfaction, and the 30-day postoperative Comprehensive Complication Index. The trial will initiate recruitment in April 2026 and conclude in December 2027, aiming to evaluate the feasibility and efficacy of PHYSIO-Prehab and provide high-quality evidence for patient-centered perioperative care pathways in this population.",[103,104,105,106,107],"Spine Degeneration","Lumbar Degenerative Disease","Frail Elderly","Enhanced Recovery After Surgery (ERAS) Protocol","Prehabilitation",[107,109,110,111],"ERAS","lumbar fusion","ADL","2026-04-26",{"date":114,"type":115},"2026-04-28","ACTUAL",{"date":117,"type":115},"2026-04-15",{"date":119,"type":97},"2027-12-30",{"name":5,"class":6},4]