[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542611":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":31,"locations":41,"responsibleParty":58,"collaborators":18,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":70,"enrollmentInfo":71,"targetDuration":18,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":82,"overallStatus":43,"whyStopped":18,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"National Geriatric Hospital","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","EXPERIMENTAL","The intervention group receives supervised Otago exercise program and baseline treatment for type2 diabetes mellitus:\n\nThe Otago exercise program aims to increase muscle strength and improve the patient's balance. The training duration is 24 weeks, the frequency is thrice a week, and the intensity gradually increases based on the Personal Therapist (PT) assessment.\n\nBaseline treatment for diabetes: Recommendations according to American Diabetes Association guidelines, which include instructions to follow the diet and exercises as recommended for older type 2 diabetic patients",[13],"Behavioral: Otago exercise program",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","NO_INTERVENTION","The control group receives the baseline treatment for type2 diabetes mellitus:\n\nBaseline treatment for diabetes: Recommendations according to American Diabetes Association guidelines, which include instructions to follow the diet and exercises as recommended for older type 2 diabetic patients",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Otago exercise program","The OEP consists of 17 strength and balance exercises and a walking program performed thrice a week by the older adult at home.\n\nProgram Prescription The program is designed to be delivered over 6 months and includes a minimum of 5 visits. The first visit is Day 1 of Otago when performance of the functional measures is assessed, and the exercises are prescribed at the Rehabilitation Center of the National Geriatric Hospital. Then, the therapist will see the patient for 4 visits over an 8-week period (typically every other week). This is considered the initial bolus of Otago. Then, the therapist will follow the patient via phone calls every week and make a visit at three months, four months, five months, and six months to reassess the patient's training ability and compliance.\n\nMonitoring:\n\nCalendars can be completed each month to document any falls. A calendar or diary can be used to monitor compliance with the exercise programme",[9],[26],"OEP",[28],{"name":29,"affiliation":5,"role":30},"Huyen TT Vu, PhD","STUDY_CHAIR",[32,37],{"name":33,"role":34,"phone":35,"phoneExt":18,"email":36},"Hoa T Dinh, MD","CONTACT","+84858038888","dinhtrunghoa95@gmail.com",{"name":38,"role":34,"phone":39,"phoneExt":18,"email":40},"Tam N Nguyen, PhD","+84979221905","ngoctam@hmu.edu.vn",[42],{"facility":5,"status":43,"city":44,"state":18,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Hanoi","100000","Vietnam","VN",{"type":49,"coordinates":50},"Point",[51,52],105.84117,21.0245,{"lat":52,"lon":51},[55],{"name":29,"role":34,"phone":56,"phoneExt":18,"email":57},"+84913531579","vuthanhhuyen11@yahoo.com",{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Dinh Trung Hoa","Endocrinologist Principal Investigator and Sponsor","100542611","evaluate-the-results-of-fall-prevention-in-older-adults-with-type-2-diabetes-mellitus-100542611",false,"NCT06345118","Evaluate the Results of Fall Prevention in Older Adults With Type 2 Diabetes Mellitus","FallT2DMOLD","Inclusion Criteria:\n\nFor the first objective (Cross-sectional study):\n\n* Type 2 diabetic patients diagnosed using American Diabetes Association 2022 criteria\n* HbA1c ≥ 7.0 and ≤ 9%\n* Age ≥ 60 and ≤ 80\n\nFor the second objective (Longitudinal study):\n\n* All patients recruited from the first objective are at moderate or high risk of falls according to the criteria of World Guidelines for Falls Prevention and Management for Older Adults - British Geriatric Society.\n\nExclusion Criteria:\n\n* Acute diabetic complications\n* Patients are in the acute phase of musculoskeletal disorders: acute gout, progressing low-grade arthritis, acute joint pain due to joint degeneration, sciatic pain, and infectious arthritis.\n* Patients suffer from conditions significantly affecting cognition and mobility: sequelae of stroke (with weakness, limb paralysis), muscular weakness, limb disabilities, severe heart failure, severe cognitive decline, and psychiatric disorders.\n* Patients have been bedridden due to illness for more than one month within the past three months up to the recruitment time.\n* Patients with cardiovascular diseases: chest pain, uncontrolled blood pressure ≥160\u002F100 mmHg, untreated cardiac arrhythmia, a history of congestive heart failure, severe valvular heart disease, myocarditis or pericarditis, and hypertrophic cardiomyopathy.","ALL","60 Years",{"count":72,"type":73},80,"ESTIMATED","INTERVENTIONAL",[76],"NA",".This randomized controlled clinical trial aims to evaluate the effects of fall prevention in older adults with type 2 diabetes mellitus. The main questions it aims to answer are:\n\n* Describe the current situation of falls, the risk of falls, and some related factors in elderly type 2 diabetic patients\n* Evaluate the results of fall prevention and related factors in the study population.\n\nParticipants will be randomly divided into control and intervention groups. The intervention group will be trained to follow the Otago Training Program as the primary fall prevention method. On the other hand, the control group will receive the standard care following the treatment guidelines for type 2 diabetes mellitus and other comorbidities.\n\nAt the end of the intervention, the study will mainly compare the rate of fall incidents after 6 months of intervention as well as other physical performance tests.",[79,80,81],"Diabetes Mellitus, Type 2","Fall","Elderly Patient",[83,84,85],"Falls prevention","Diabetes Mellitus type2","Elderly patient","2024-11-12",{"date":88,"type":89},"2024-11-13","ACTUAL",{"date":91,"type":89},"2024-03-01",{"date":93,"type":73},"2025-12-31",{"name":5,"class":6},1]