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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 University1 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1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
1
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
否

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

研究组 & 干预措施

Resistance exercise and protein products

Experimental

Practice intervention trial including resistance exercise training and intake of dietary protein products in (frail) elderly, implemented by health care professionals.

干预措施: Dietary protein products (Dietary Supplement)

Resistance exercise and protein products

Experimental

Practice intervention trial including resistance exercise training and intake of dietary protein products in (frail) elderly, implemented by health care professionals.

干预措施: Resistance exercise training (Other)

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 (1)

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