Evaluating Resistance Training for Sarcopenia in Older Patients With Type 2 Diabetes: Treatment Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Muscle mass
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetic patients diagnosed using American Diabetes Association 2022 criteria
- •HbA1c ≥ 7.0 and ≤ 8.5%
- •Sarcopenia diagnosed using criteria from the Asian Working Group for Sarcopenia 2019
- •Age ≥ 60 and ≤ 80
排除标准
- •Acute diabetic complications
- •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.
- •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.
- •Patients have been bedridden due to illness for more than 1 month within the past 3 months up to the recruitment time.
- •Patients with cardiovascular diseases: chest pain, uncontrolled blood pressure ≥160/100 mmHg, untreated cardiac arrhythmia, a history of congestive heart failure, severe valvular heart disease, myocarditis or pericarditis, and hypertrophic cardiomyopathy.
- •Renal failure with estimated glomerular function rate (Modification of Diet in Renal Disease equation) < 60 ml/min/m3 or serum creatinine ≥ 130 µmol/l
- •On treatment with Sodium-glucose cotransporter 2 inhibitors (SGLT2i)
结局指标
主要结局
Muscle mass
时间窗: Prior to the start of intervention, after 4 weeks, 8 weeks and 12 weeks (completion of the intervention)
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.
Physical performance 1 - Handgrip strength
时间窗: Prior to the start of intervention, after 4 weeks, 8 weeks and 12 weeks (completion of the intervention)
Handgrip strength is assessed using a hand dynamometer named Jamar Hydraulic Hand Dynamometer: the higher number the better outcome.
Physical performance 2 - Gait speed
时间窗: Prior to the start of intervention, after 4 weeks, 8 weeks and 12 weeks (completion of the intervention)
4-metre gait speed test (the shorter time the better outcome)
Physical performance 3 - Short Physical Performance Battery (SPPB)
时间窗: Prior to the start of intervention, after 4 weeks, 8 weeks and 12 weeks (completion of the intervention)
The Short Physical Performance Battery developed by the National Institute on Aging: scores ranging from 0 (worst) to 12 (best)
次要结局
- Health-related Quality of Life(Prior to the start of intervention (Week 0), following the completion of the intervention (Week 12))
- Activities of Daily Living (ADLs) and Instrumental Activities of Daily Living (IADLs)(Prior to the start of intervention (Week 0), following the completion of the intervention (Week 12))
- Nutritional status(Prior to the start of intervention (Week 0), following the completion of the intervention (Week 12))
研究者
Trinh Ngoc Anh
Endocrinologist, Principal Investigator and Sponsor
National Geriatric Hospital