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The Effect of Strength Training and Protein Supplementation in Old Pre-frail Individuals

2019年3月12日 更新者:Truls Raastad、Norwegian School of Sport Sciences

Strength Training and Protein Supplementation in Pre-frail Elderly Individuals. Effects on Muscle Mass, Muscle Strength, Rate of Force Development and Functional Capacity

The aim of this study is to investigate the effects of a lower-body strength training regime combined with protein supplementation in pre-frail elderly individuals. Participants are randomized to a group performing three weekly sessions of heavy-load strength training for 10 weeks and receiving daily protein supplementation, or a non-training, non-supplemented control group. The endpoints are changes in body composition, the relative changes in different compartments of the quadriceps femoris muscles, and the relationships between changes in muscle mass, muscle thickness, strength, and functional capacity. The investigators hypothesize that 10 weeks of heavy load strength training and protein supplementation will elicit improvements in muscle mass, strength, and functional performance. Moreover, it is hypothesized that improvements in strength will correlate with the improvements in functional performance.

研究概览

详细说明

Aging is accompanied by a loss of muscle mass and strength. Because muscle strength is associated with functional performance in elderly individuals, various tasks of daily living is hampered by the overall decline. The consequence is a vicious circle, where inactivity caused by reduced functional capacity accelerates the loss of muscle mass, strength and physical function. The Short Physical Performance Battery (SPPB) is commonly used to assess functional capacity, where individuals with a score of 10 or less out of maximum 12 may be categorized as pre-frail. Because small-to-moderate limitations in functional status assessed by SPPB is associated with higher odds of losing future mobility, these individuals represent a group of great interest. Strategies to improve functional capacity in this population are therefore important. It is established that heavy-load strength training, alone or in combination with protein supplementation, can improve muscle mass, strength, and function in elderly individuals. However, most studies have focused on healthy older adults, and less is known about the effects of heavy-load strength training in pre-frail elderly individuals. Moreover, the extent to which training-induced gains in muscle mass and size are related to improvements in strength and functional capacity is still poorly understood, because few intervention studies in this population have quantified hypertrophy precisely. Hence, the aim of this study is to investigate the effects of 10 weeks of heavy load strength training, performed three times per week, on muscle mass (DXA scan), muscle thickness (ultrasound), muscle strength (dynamic and isometric), rate of force development, chair rise ability, and gait velocity. Participants are randomized to a group performing three weekly sessions of heavy-load strength training or a control group. In addition, to optimize gains in muscle mass and strength, the strength training group will receive daily protein supplementation throughout the intervention period. The investigators hypothesize that the intervention will improve muscle mass, muscle thickness and strength, and that improvements in muscle strength and rate of force development will be correlated with improvements in functional capacity.

研究类型

介入性

注册 (实际的)

22

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Oslo、挪威、0863
        • Norwegian School of Sport Sciences

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

75年 及以上 (年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Age > 75
  • Short Physical Performance Battery (SPPB) score ≤ 10

Exclusion Criteria:

  • Lactose intolerance
  • Milk allergy
  • Diseases or musculoskeletal disorders contraindicating training/testing

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:基础科学
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
无干预:控制
无干预
实验性的:Strength training + protein supplement
Heavy-load strength training, Protein supplementation
Three weekly sessions of heavy-load strength training for 10 weeks
其他名称:
  • 阻力运动
Daily supplementation of 2 x 17 grams of milk protein

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Muscle strength of m. Quadriceps Femoris
大体时间:Change from baseline at 10 weks
Maximal isometric muscle strength of m. quadriceps femoris (maximal voluntary contraction for the knee extensors)
Change from baseline at 10 weks
Muscle strength of m. quadriceps femoris
大体时间:Change from baseline at 10 weeks
Maximal dynamic muscle strength of m. quadriceps femoris (knee extension 1 repetition maximum)
Change from baseline at 10 weeks
Leg lean mass
大体时间:Change from baseline at 10 weeks
Measured by Dual-energy X-ray Absorptiometry (DXA-scan)
Change from baseline at 10 weeks

次要结果测量

结果测量
措施说明
大体时间
米。股外侧肌厚度
大体时间:10 周时基线的变化
超声波测量
10 周时基线的变化
Total lean mass
大体时间:Change from baseline at 10 weeks
Measured by Dual-energy X-ray Absorptiometry (DXA-scan)
Change from baseline at 10 weeks
Fat mass
大体时间:Change from baseline at 10 weeks
Measured by Dual-energy X-ray Absorptiometry (DXA-scan)
Change from baseline at 10 weeks
Bone mineral density
大体时间:Change from baseline at 10 weeks
Measured by Dual-energy X-ray Absorptiometry (DXA-scan)
Change from baseline at 10 weeks
m. Rectus Femoris thickness
大体时间:Change from baseline at 10 weeks
Measured by ultrasound
Change from baseline at 10 weeks
m. Vastus Intermedius thickness
大体时间:Change from baseline at 10 weeks
Measured by ultrasound
Change from baseline at 10 weeks
m. Vastus Medialis thickness
大体时间:Change from baseline at 10 weeks
Measured by ultrasound
Change from baseline at 10 weeks
Isometric knee extension rate of force development (RFD max)
大体时间:Change from baseline at 10 weeks
Measured during maximal voluntary contraction
Change from baseline at 10 weeks
Isometric knee extension force at 100 ms
大体时间:Change from baseline at 10 weeks
Force at 100 ms during maximal voluntary contraction
Change from baseline at 10 weeks
Habitual gait velocity
大体时间:Change from baseline at 10 weeks
Time (sec) to walk 6 meters at preferred gait speed
Change from baseline at 10 weeks
Five times chair-rise performance
大体时间:Change from baseline at 10 weeks
Time (sec) to rise from a chair five times
Change from baseline at 10 weeks
Stair climbing
大体时间:Change from baseline at 10 weeks
Time (sec) to climb a staircase
Change from baseline at 10 weeks
Diet assessment
大体时间:Change from baseline at 10 weeks
24-hour diet recall interviews
Change from baseline at 10 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2015年7月1日

初级完成 (实际的)

2015年12月21日

研究完成 (实际的)

2015年12月21日

研究注册日期

首次提交

2018年10月26日

首先提交符合 QC 标准的

2018年10月29日

首次发布 (实际的)

2018年10月30日

研究记录更新

最后更新发布 (实际的)

2019年3月14日

上次提交的符合 QC 标准的更新

2019年3月12日

最后验证

2019年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • ST-PF

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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