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临床试验/NCT01775111
NCT01775111Unknown不适用

Influence of Strength Training and Nutritional Supplementation on Physical Performance and Well-being of Older People in Pensioner Homes

University of Vienna1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2012年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
120
试验地点
1
主要终点
change from baseline in isokinetic torque of knee extensors

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Investigator)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Cognitive Training

Sham Comparator

Cognitive Training (riddles, skill games, ...) is performed twice a week in small groups

干预措施: Cognitive Training (Behavioral)

Strength Training

Experimental

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.

干预措施: Strength Training (Behavioral)

Strength Training and Supplement

Experimental

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.

干预措施: Strength Training (Behavioral)

Strength Training and Supplement

Experimental

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.

干预措施: FortiFit (Dietary Supplement)

结局指标

主要结局

change from baseline in isokinetic torque of knee extensors

时间窗: baseline and 6 months

次要结局

  • change from baseline in 6min walking test(baseline and 6 months)
  • change from baseline in handgrip strength(baseline and 6 months)
  • change from baseline in single leg balance stand(baseline and 6 months)
  • change from baseline in lean body mass(baseline and 6 months)
  • change from baseline in muscular myostatin expression(baseline and 6 months)
  • change from baseline in DNA strand breaks(baseline and 6 months)
  • change from baseline in high-sensitive C reactive protein(baseline and 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ass.-Prof. DI Dr. Barbara Wessner

Ass.Prof. DI Dr.

University of Vienna

研究点 (1)

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