Influence of Strength Training and Protein Supplementation on Fitness of Institutionalized Elderly
Influence of Strength Training and Nutritional Supplementation on Physical Performance and Well-being of Older People in Pensioner Homes
The aim of this randomized, observer-blind, controlled intervention study with parallel groups is to study the effect of strength training (2x/week for 6 months) with and without additional dietary supplementation (protein-enriched) on muscle strength, function and mass, oxidative stress parameters and the immune system in elderly institutionalized persons.
The participants (n = 120) are recruited from Viennese senior residencies (Kuratorium Wiener Pensionistenwohnheime). After a pre-participation screening participants will be distributed randomly but stratified by sex and age to one of the 3 intervention groups (cognitive training, strength training, strength training + supplement).
Study participants are eligible if they are male or female with an age over 65 years and if their cognitive status as well as their physical fitness level allows to participate at the strength training sessions. Exclusion criteria comprise chronic diseases which contraindicate the medical training therapy, serious cardiovascular disease, diabetic retinopathy and manifest osteoporosis, medication with anticoagulants or cortisone drugs and also regular strength training during the last six months.
Primary outcome measure is the change in isokinetic torque of knee extensors. Secondary outcome measures comprise anthropometric data, functional performance tests, immunological and oxidative stress parameters. The change in muscle signaling pathways will be assessed from muscle biopsies.
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Vienna、奥地利、1150
- 招聘中
- University of Vienna, Centre of Sports Science and University Sports
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接触：
- Barbara Wessner, Ass.-Prof. DI Dr.
- 电话号码：28772 +4314277
- 邮箱：barbara.wessner@univie.ac.at
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首席研究员：
- Barbara Wessner, Ass.-Prof. DI Dr.
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Adequate mental condition in order to follow the instructions and to perform the resistance exercise independently (Mini-Mental-State >23)
- Ability to walk 10 meters independently (without orthopaedic devices)
- 4 or more points at the Short Physical Performance Battery
Exclusion Criteria:
- Chronic diseases, which contraindicate a medical training therapy
- Serious cardiovascular diseases (congestive chronic heart failure, severe or symptomatic aortic stenosis, unstable angina pectoris, untreated arterial hypertension, cardiac arrhythmias)
- Diabetic retinopathy
- Manifest osteoporosis
- Regular use of cortisone-containing drugs
- Regular strength training (> 1x / week) in the last 6 months before inclusion
学习计划
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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假比较器：Cognitive Training
Cognitive Training (riddles, skill games, ...) is performed twice a week in small groups
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实验性的：Strength Training
Progressive strength training is applied, meaning that the intensity is adjusted continuously in order to obtain a sufficient training stimulus.
Exercises are chosen to involve the major muscle groups and are performed by using the own body weight or elastic bands.
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实验性的：Strength Training and Supplement
In addition to strength training as described above, participants receive a water-soluble dietary supplement 9x/week (FortiFit, Nutricia) consisting of 20.7 g of protein (56 En%, 19.7 g whey protein, 3 g leucine,> 10 g essential amino acids), 9.3 g carbohydrates (25 En%, 0.8 BE), 3.0 g fat (18 En%), 1.2 g fiber (2 En%), 800 IU (20μg) of vitamin D, 250mg calcium, vitamins B6 and B12, folic acid and magnesium.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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change from baseline in isokinetic torque of knee extensors
大体时间：baseline and 6 months
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baseline and 6 months
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次要结果测量
结果测量 |
大体时间 |
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change from baseline in 6min walking test
大体时间：baseline and 6 months
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baseline and 6 months
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change from baseline in handgrip strength
大体时间：baseline and 6 months
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baseline and 6 months
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change from baseline in single leg balance stand
大体时间：baseline and 6 months
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baseline and 6 months
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change from baseline in lean body mass
大体时间：baseline and 6 months
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baseline and 6 months
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change from baseline in muscular myostatin expression
大体时间：baseline and 6 months
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baseline and 6 months
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change from baseline in DNA strand breaks
大体时间：baseline and 6 months
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baseline and 6 months
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change from baseline in high-sensitive C reactive protein
大体时间：baseline and 6 months
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baseline and 6 months
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其他结果措施
结果测量 |
大体时间 |
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change from baseline in isokinetic torque of knee extensors at 12 months
大体时间：baseline and 12 months
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baseline and 12 months
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change from baseline in isokinetic torque of knee extensors at 18 months
大体时间：baseline and 18 months
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baseline and 18 months
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合作者和调查者
调查人员
- 首席研究员：Barbara Wessner, Ass.-Prof. DI Dr.、University of Vienna
出版物和有用的链接
一般刊物
- Franzke B, Schober-Halper B, Hofmann M, Oesen S, Tosevska A, Henriksen T, Poulsen HE, Strasser EM, Wessner B, Wagner KH. Age and the effect of exercise, nutrition and cognitive training on oxidative stress - The Vienna Active Aging Study (VAAS), a randomized controlled trial. Free Radic Biol Med. 2018 Jun;121:69-77. doi: 10.1016/j.freeradbiomed.2018.04.565. Epub 2018 Apr 24.
- Tosevska A, Franzke B, Hofmann M, Vierheilig I, Schober-Halper B, Oesen S, Neubauer O, Wessner B, Wagner KH. Circulating cell-free DNA, telomere length and bilirubin in the Vienna Active Ageing Study: exploratory analysis of a randomized, controlled trial. Sci Rep. 2016 Dec 1;6:38084. doi: 10.1038/srep38084.
- Grimpampi E, Oesen S, Halper B, Hofmann M, Wessner B, Mazza C. Reliability of gait variability assessment in older individuals during a six-minute walk test. J Biomech. 2015 Nov 26;48(15):4185-4189. doi: 10.1016/j.jbiomech.2015.10.008. Epub 2015 Oct 20.
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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