Effectiveness and Clinical Application of Multidisciplinary Combined Exercise and Nutrition Intervention for Sarcopenic Older Adults With Metabolic Syndrome: Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 2
- 主要终点
- 5-times chair stand test
研究概览
简要总结
This study aims to demonstrate the effect of combined exercise-nutrition intervention in old adults with sarcopenia. This study will be conducted with prospectively randomized controlled trial comparing outcome of combined exercise-nutrition intervention with conventional medical care. Handgrip strength, gait speed, knee extensor muscle power, physical performance, muscle mass using DEXA, quality of life, activities of daily living, sarcopenia screening questionnaire, nutritional assessment will be evaluated on baseline, 12-weeks and 24-weeks after intervention.
详细描述
The definition of sarcopenia is age-related loss of skeletal muscle and physical functions. Sarcopenia is emerging health problem and increases medical expenditure as the population ages. Sarcopenia is closely related to chronic diseases and geriatric diseases. In particular, patients with metabolic syndrome showed a high prevalence of muscle loss and muscle weakness. It has been reported exercise in sarcopenia patients not only improved insulin sensitivity and physical performance but also helped the treatment of the diseases. Also, it is recently demonstrated that combined exercise-nutrition intervention improved muscle function in elderly patients. However, there is still not established standard protocol for the combined exercise-nutrition intervention. Therefore, the aim of this trial is to compare the effects of combined exercise-nutrition intervention in sarcopenia patients with multicenter, multidisciplinary, randomized controlled trial.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients older than 65 years and under 90 years
- •patients who meet the criteria for the Asian Working Group for Sarcopenia (AWGS) 2019
- •patients who had metabolic syndrome
排除标准
- •patients with less than estimated glomerular filtration rate (eGFR) 30
- •patients with musculoskeletal or chronic lung disease incapable of exercise
- •patients with untreated or uncontrolled cardiovascular disease which may affect muscle mass or performing exercise
- •patients less than 5 years after treatment of malignant tumor
- •patients with liver cirrhosis, diabetes and other chronic disease
- •patients who cannot perform combined exercise nutrition intervention for other reasons
结局指标
主要结局
5-times chair stand test
时间窗: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)
Change from baseline 5-times chair stand test to 12 weeks after assessment, measured by 5-times chair stand test
次要结局
- Physical performance(Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3))
- Gait speed test(Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3))
- Appendicular skeletal muscle mass(Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3))
- Health Related Quality of Life(Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3))
- Basic and instrumental activities of daily living(Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3))
- Sarcopenia screening questionnaire(Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3))
- Nutritional Assessment(Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3))
- Handgrip strength(Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3))
- Delirium assessment(Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3))
- Physical acitivity assessment(Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3))
- Cognitive assessment(Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3))
- Psychiatric state(Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3))
- Swallowing assessment(Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3))
- Empowerment assessment(Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3))
研究者
Jae-Young Lim
Professor
Seoul National University Bundang Hospital