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临床试验/NCT02434289
NCT02434289已完成不适用

Pilot Study to Study the Feasibility and Potential Impact of a Combined Resistance Exercise and Increased Protein Intake Intervention in (Frail) Elderly People, in a Real-life Setting

Wageningen University2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
2
主要终点
Feasibility of intervention implementation

研究概览

简要总结

The purpose of this pilot study is to investigate the feasibility and potential impact of a combined resistance exercise and increased protein intake intervention in (frail) elderly, in a real-life setting.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • In home assisted (also informal care) elderly individuals, that experience loss of muscle strength
  • Able to understand and perform the study procedures

排除标准

  • Type I or type II diabetes (fasted blood glucose level ≥7,0 mmol) or hypertension, unless well regulated by medication
  • Diagnosed cancer or Chronic Obstructive Pulmonary Disease (COPD)
  • Severe heart failure
  • Renal insufficiency (eGFR <60 mL/min/1.73 m2)
  • Newly placed hip/knee prosthesis (unless fully recovered), or recent surgery (stress on scar tissue)
  • Allergic or sensitive for milk proteins

结局指标

主要结局

Feasibility of intervention implementation

时间窗: After 12 weeks

Feasibility includes acceptability, applicability, dose received and implementation integrity. Collected in both participants and implementing health care professionals

次要结局

  • Change in Quality of life, as measured by Short-Form 36 (SF-36)(Baseline and 12 weeks)
  • Change in Activities of Daily Living (ADL) functioning, as measured by ADL-questionnaire(Baseline and 12 weeks)
  • Change in physical performance, as measured by Short Physical performance Battery (SPPB), Timed Up-and-Go (TUG) and Six Minute Walking Test (6MWT)(Baseline and 12 weeks)
  • Change in skeletal muscle mass, as measured by Dual-energy X-ray Absorptiometry (DEXA)(Baseline and 12 weeks)
  • Change in muscle strength, as measured by a maximum strength test(Baseline and 12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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