[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100417430":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":36,"centralContacts":40,"locations":50,"responsibleParty":66,"collaborators":20,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":20,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":20,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":93,"overallStatus":52,"whyStopped":20,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Peking University First Hospital","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Multicomponent prehabilitation group","EXPERIMENTAL","Patients in the intervention group will receive nutritional optimization and exercise training before the surgery, exercise training after the surgery, and home-based rehabilitation after discharge.",[13,14,15],"Dietary Supplement: Preoperative nutritional optimization","Behavioral: Preoperative exercise training","Behavioral: Postoperative exercise training",{"label":17,"type":18,"description":19,"interventionNames":20},"Control group","NO_INTERVENTION","Patients in the control group will maintain normal diet and normal activity before surgery, normal activity after surgery, and normal activity after discharge.",null,[22,27,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":20},"DIETARY_SUPPLEMENT","Preoperative nutritional optimization","1. Indication for oral nutritional supplementation: Patients at risk of malnutrition (MNA-SF 8-11) or with malnutrition (MNA-SF 0-7).\n2. Protocol of nutritional optimization: Enteral nutritional powder (Ensure for patients without diabetes and Glucerna for patients with diabetes) twice a day. The target protein intake is 1.5-1.8 g\u002Fkg\u002Fd. Patients with iron deficient anemia (hemoglobin \\\u003C130 g\u002FL for men and \\\u003C120 g\u002FL for women) will be given oral iron therapy.\n3. The duration of nutritional optimization: The day admitted to the hospital to the surgery to one day prior to the surgery.",[9],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":20},"BEHAVIORAL","Preoperative exercise training","1. The respiratory training will be performed for at least 2-3 times per day. Respiratory training include thoracic breathing exercise and cough training.\n2. Aerobic exercise will be performed for at least 1-2 times per day. Aerobic exercise includes jogging, walking or climbing stairs. Exercise intensity will be based on patients' tolerance. The goal of the training is to complete the training plan as far as possible.\n3. Every training should be last for 45 minutes to 1 hour. If the patient can not tolerate, the training time should be reduce to 30 minutes.\n4. The duration of exercise training: The day admitted to the hospital to the surgery to one day prior to the surgery.",[9],{"type":28,"name":33,"description":34,"armGroupLabels":35,"otherNames":20},"Postoperative exercise training","1. Muscle strength training in the bedside and walking in the ward.\n2. Aerobic exercise includes jogging, walking or climbing stairs. Exercise intensity will be based on patients' tolerance. The goal of the training is to complete the training plan as far as possible.\n3. Exercise training is performed under the supervision of physiotherpists durign hospital stay, and is reminded by regular telephone calls and phone messages after hospital discharge.",[9],[37],{"name":38,"affiliation":5,"role":39},"Dong-Xin Wang, MD, PhD","PRINCIPAL_INVESTIGATOR",[41,46],{"name":42,"role":43,"phone":44,"phoneExt":20,"email":45},"Dong-Xin Wang, MD","CONTACT","+8613910731903","wangdongxin@hotmail.com",{"name":47,"role":43,"phone":48,"phoneExt":20,"email":49},"Huai-Jin Li, MD","+8613488659162","sophie.lee.coffee@gmail.com",[51],{"facility":5,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"RECRUITING","Beijing","Beijing Municipality","100034","China","CN",{"type":59,"coordinates":60},"Point",[61,62],116.39723,39.9075,{"lat":62,"lon":61},[65],{"name":47,"role":43,"phone":20,"phoneExt":20,"email":49},{"type":39,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Dong-Xin Wang","Professor","100417430","multicomponent-prehabilitation-and-outcomes-in-elderly-patients-with-frailty-100417430",false,"NCT04715581","Multicomponent Prehabilitation and Outcomes in Elderly Patients With Frailty","Effect of Multicomponent Prehabilitation on Early and Long-term Outcomes in Elderly Patients With Frailty After Digestive Surgery for Cancer: A Randomized-controlled Study","Inclusion criteria:\n\n1. Age ≥65 years but \\\u003C90 years;\n2. Scheduled to undergo major surgery for digestive cancer with an expected duration of 2 hours and longer, including cancers of esophagus, stomach, small intestine, colon, rectum, pancreas, liver, and biliary tract;\n3. Clinical Frailty Scale ≥5;\n4. Provide written informed consent.\n\nExclusion Criteria:\n\n1. Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis;\n2. Inability to communicate due to coma, profound dementia, or language barrier;\n3. Inability to participate in preoperative rehabilitation due to paralysis, fracture or other movement disorder;\n4. Inability to take oral diet due to preoperative gastrointestinal disease or other disease;\n5. Severe heart dysfunction (left ventricular ejection fraction \\\u003C30% or New York Heart Association classification IV), severe hepatic dysfunction (Child-Pugh class C), severe renal dysfunction (undergoing dialysis before surgery), or American Society of Anesthesiologists classification of grade 4 or higher;\n6. Other reasons that are considered unsuitable for study participation.","ALL","65 Years","89 Years",{"count":80,"type":81},540,"ESTIMATED","INTERVENTIONAL",[84],"NA","The study is designed to investigate the effect of a multicomponent prehabilitation pathway on early and long-term outcomes in elderly patients with frailty recovering from surgery for digestive cancer.",[87,88,89,90,91,92],"Old Age; Debility","Digestive Cancer","Surgery","Preoperative Rehabilitation","Nutrition Therapy","Outcomes",[94,95,96,97,98,99],"older patients","frailty","digestive cancer","prehabilitation","nutrition therapy","outcomes","2025-07-29",{"date":102,"type":103},"2025-07-31","ACTUAL",{"date":105,"type":103},"2021-11-25",{"date":107,"type":81},"2028-12",{"name":5,"class":6},1]