[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542014":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":40,"studyPopulation":33,"armGroups":41,"interventions":52,"overallOfficials":58,"centralContacts":62,"locations":72,"responsibleParty":89,"collaborators":33,"id":93,"slug":33,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":33,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":33,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":112,"overallStatus":74,"whyStopped":33,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"National Geriatric Hospital","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":33},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"Physical performance 1 - Handgrip strength","Handgrip strength is assessed using a hand dynamometer named Jamar Hydraulic Hand Dynamometer: the higher number the better outcome.","Prior to the start of intervention, after 4 weeks, 8 weeks and 12 weeks (completion of the intervention)",{"measure":14,"description":15,"timeFrame":12},"Physical performance 2 - Gait speed","4-metre gait speed test (the shorter time the better outcome)",{"measure":17,"description":18,"timeFrame":12},"Physical performance 3 - Short Physical Performance Battery (SPPB)","The Short Physical Performance Battery developed by the National Institute on Aging: scores ranging from 0 (worst) to 12 (best)",{"measure":20,"description":21,"timeFrame":12},"Muscle mass","Upper and lower muscle mass are measured by Bioelectrical impedance analysis (BIA) method, using a machine model named InBody 770: the higher number the better outcome.",[23,27,30],{"measure":24,"description":25,"timeFrame":26},"Nutritional status","Nutritional status is assessed using the Mini Nutritional Assessment Short-Form (MNA-SF): scores ranging from 0 (worst) to 14 (best)","Prior to the start of intervention (Week 0), following the completion of the intervention (Week 12)",{"measure":28,"description":29,"timeFrame":26},"Health-related Quality of Life","Health-related Quality of Life is assessed using the health questionnaire 5-level 5 dimensions from EuroQol Group: index scores range from -0.59 to 1; 1 is the best possible health state.",{"measure":31,"description":32,"timeFrame":26},"Activities of Daily Living (ADLs) and Instrumental Activities of Daily Living (IADLs)","Katz Index of Independence in Activities of Daily Living (scores range from 0-worst to 6-best) and Lawton Instrumental Activities of Daily Living Scale (scores range from 0-low function \\& dependent to 8-high function \\& independent for women, and 0-worst to 5-best for men)",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":33,"primaryPurpose":37,"observationalModel":33,"timePerspective":33,"maskingInfo":38},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":39,"maskingDescription":33,"whoMasked":33},"NONE","Sarcopenia, prevalent among geriatric populations, involves the progressive loss of muscle mass and decline in muscular function. This age-related condition is associated with higher susceptibility to falls, comorbidities, and mortality. Resistance training emerges as a non-pharmacological intervention proven to alleviate and potentially delay the progression of sarcopenia. However, there are still few studies investigating its effects on outcomes in older patients with diabetes mellitus.",[42,48],{"label":43,"type":44,"description":45,"interventionNames":46},"Intervention group","EXPERIMENTAL","The intervention group receives supervised resistance training instructions and baseline treatment for sarcopenia and diabetes:\n\n* Resistance training with elastic bands aims to increase muscle strength and muscle mass of the upper and lower limbs. Training duration 12 weeks, frequency 2 times\u002Fweek, intensity gradually increases.\n* Baseline treatment for diabetes and sarcopenia: Recommendations according to American Diabetes Association guidelines which include instructions to follow the diet and exercises as recommended for older type 2 diabetic patients and baseline treatment for sarcopenia (education about sarcopenia and treatment measures such as diet and exercise) and provide basic information on resistance training.",[47],"Behavioral: Progressive Resistance Training",{"label":49,"type":50,"description":51,"interventionNames":33},"Control group","NO_INTERVENTION","The control group receives the baseline treatment for diabetes and sarcopenia:\n\n\\- Recommendations according to American Diabetes Association guidelines which include instructions to follow the diet and exercises as recommended for older type 2 diabetic patients and baseline treatment for sarcopenia (education about sarcopenia and treatment measures such as diet and exercise) and provide basic information on resistance training.",[53],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":33},"BEHAVIORAL","Progressive Resistance Training","Progressive resistance training includes face-to-face education on resistance training:\n\nResistance exercises with elastic bands include 9 exercises for 1 course. During the first 4 weeks, the patient exercises twice a week with a level of exertion according to Borg's category-ratio 10 (CR10) scale of 4-5 points. For the next 4 weeks, the patient exercises twice a week with Borg's CR10 exertion level of 6-7 points. In the last 4 weeks, the patient exercises twice a week with Borg's CR10 exertion level of 8-9 points.\n\nThe three-month intervention involves twelve weekly calls, with a focus on building rapport (e.g. providing feedback on the baseline assessment); education reinforcement on resistance training; and skill-building (e.g. self-monitoring and resistance training diary). The emphasis is on helping participants to gain the knowledge and skills necessary to achieve targeted intensity. Every 4 weeks, all patients are re-visited by investigators in the hospital.",[43],[59],{"name":60,"affiliation":5,"role":61},"Huyen TT Vu, PhD","STUDY_CHAIR",[63,68],{"name":64,"role":65,"phone":66,"phoneExt":33,"email":67},"Anh N Trinh, MD","CONTACT","(+84) 912760684","drtrinhanh.endo@gmail.com",{"name":69,"role":65,"phone":70,"phoneExt":33,"email":71},"Tam N Nguyen, PhD","+84979221905","ngoctam@hmu.edu.vn",[73],{"facility":5,"status":74,"city":75,"state":33,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"RECRUITING","Hanoi","100000","Vietnam","VN",{"type":80,"coordinates":81},"Point",[82,83],105.84117,21.0245,{"lat":83,"lon":82},[86],{"name":60,"role":65,"phone":87,"phoneExt":33,"email":88},"+84913531579","vuthanhhuyen11@yahoo.com",{"type":90,"investigatorFullName":91,"investigatorTitle":92,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"PRINCIPAL_INVESTIGATOR","Trinh Ngoc Anh","Endocrinologist, Principal Investigator and Sponsor","100542014",false,"NCT06337357","Results of Progressive Resistance Training in Older Type 2 Diabetic Patients With Sarcopenia","Evaluating Resistance Training for Sarcopenia in Older Patients With Type 2 Diabetes: Treatment Outcomes","Inclusion Criteria:\n\n* Type 2 diabetic patients diagnosed using American Diabetes Association 2022 criteria\n* HbA1c ≥ 7.0 and ≤ 8.5%\n* Sarcopenia diagnosed using criteria from the Asian Working Group for Sarcopenia 2019\n* Age ≥ 60 and ≤ 80\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 1 month within the past 3 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.\n* Renal failure with estimated glomerular function rate (Modification of Diet in Renal Disease equation) \\\u003C 60 ml\u002Fmin\u002Fm3 or serum creatinine ≥ 130 µmol\u002Fl\n* On treatment with Sodium-glucose cotransporter 2 inhibitors (SGLT2i)","ALL","60 Years","80 Years",{"count":103,"type":104},80,"ESTIMATED","INTERVENTIONAL",[107],"NA","A randomized controlled clinical trial that will test how progressive resistance training will impact outcomes of sarcopenia in older patients with type 2 diabetes who have been diagnosed as sarcopenia. The intervention will be 12 weeks in duration with approximately 24 sessions of resistance exercises. Outcome measures will be collected at baseline, 4, 8 weeks and 12 weeks.",[110,111],"Sarcopenia","Diabetes",[110,111,113],"Resistance training","2025-05-19",{"date":116,"type":117},"2025-05-22","ACTUAL",{"date":119,"type":117},"2024-04-01",{"date":121,"type":104},"2025-12",{"name":5,"class":6},1]