Combined Effects of Resistance Training and Nutritional Supplements in the Treatment of Sarcopenia
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- muscle mass (DXA)
研究概览
简要总结
Age-related sarcopenia is associated with increased morbidity, mortality, disability and reduced resistance to metabolic stress. The aim of this study is to assess the effects of resistance training, associated or not with oral nutritional supplements, on skeletal muscle mass in sarcopenic subjects. This is a prospective randomised controlled single-centre study that will last two years, three months for a participant.
200 healthy elderly (70-80 years old) subjects will be screened for sarcopenia by dual energy X-ray absorptiometry. 128 sarcopenic subjects will be randomized into 4 groups:
- group 1: controls
- group 2: oral nutritional supplement (260 kcal and 20 g protein per day)
- group 3: resistance training (3 times per week)
- group 4: oral nutritional supplement + resistance training
Every subject will be assessed at the beginning and at the end of 12 weeks of intervention on:
- muscle mass (DXA)
- muscle function (dynamometers)
- hormonal (testosterone, GH, IGF-1, cortisol) and inflammatory (IL-6, TNF-alpha) profiles
- food intake. Ten subjects in group 4 will undergo a muscle biopsy (quadriceps) before and after the intervention in order to explore protein and mRNA levels of the mTOR pathway, which may be involved in sarcopenia.
详细描述
Age-related sarcopenia is a common situation defined by muscle mass and function loss in an otherwise healthy elderly person. Epidemiological data from the USA show 49% of men and 72% of women to suffer from sarcopenia. Few data is available on the French population. Sarcopenia is associated with increased morbidity, mortality, disability and reduced resistance to metabolic stress. Resistance training and nutrition are two non-pharmaceutical methods that may be able to prevent several age-related condition.
The aim of this study is to assess the effects of resistance training, associated or not with oral nutritional supplements, on skeletal muscle mass (expressed as skeletal muscle mass index) in sarcopenic subjects. This is a prospective randomised controlled single-centre study that will last two years, three months for a participant.
200 healthy elderly (70-80 years old) subjects will be screened for sarcopenia by dual energy X-ray absorptiometry. 128 sarcopenic subjects will be randomized into 4 groups:
- group 1: controls
- group 2: oral nutritional supplement (260 kcal and 20 g protein per day)
- group 3: resistance training (3 times per week)
- group 4: oral nutritional supplement + resistance training
Every subject will be assessed at the beginning and at the end of 12 weeks of intervention on:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 70 and 80 years
- •Stable weight (± 1 kg) during the last three months
- •Informed consent signed
- •Affiliated with the French Sécurité Sociale Non-inclusion criteria
- •Chronic cachectic condition: cancer, chronic respiratory failure, advanced organ failure, hyperthyroidism, rheumatoid arthritis, AIDS, type 1 diabetes
- •Drugs affecting muscle mass (e.g. steroids)
- •Condition (clinical or EKG) significantly affecting physical capacities and/or contra-indicating resistance training
- •Habitual practice of resistance training
- •Habitual intake of nutritional supplements
- •Known coagulation disorders (for muscle biopsy)
- •Known allergy to lidocaine (for muscle biopsy)
排除标准
- 未提供
结局指标
主要结局
muscle mass (DXA)
时间窗: D0 and after 12 weeks
次要结局
- muscle function (dynamometers), hormonal (testosterone, GH, IGF-1, cortisol) and inflammatory (IL-6, TNF-alpha) profiles, food intake, ± muscle biopsy.(D0 and after 12 weeks)