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临床试验/NCT02261350
NCT02261350终止3 期

The Effect of Nutritional Support on Gait Speed Following Hospitalisation for Acute Exacerbation of COPD

Royal Brompton & Harefield NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2014年1月1日最近更新:
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适应症
干预措施

试验速览

阶段
3 期
状态
终止
入组人数
22
试验地点
1
主要终点
Change in four-metre gait speed (m/s) following nutritional support
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To determine the feasibility of delivering different community nutritional interventions to chronic obstructive pulmonary disease (COPD) patients at moderate or severe risk of malnutrition following a hospitalisation for an acute exacerbation of COPD.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • •Ability to consent
  • •Patients at moderate or severe risk of malnutrition
  • •Adults over the age of 40
  • •Hospitalised with an AECOPD

排除标准

  • •Receiving long term parental or enteral nutrition
  • •Inability to swallow or difficulty liquids
  • •Lactose intolerance, galactosaemia, cow's milk protein allergy or intolerance
  • •Co-existing active cancer, progressive neurological condition or active GI disorder.
  • •Receiving palliative care with expectation of death within 3 months
  • •Cognitive dysfunction or unable to consent

研究组 & 干预措施

Oral Nutritional Supplements

Experimental

Oral Nutritional Supplements - Fortisip Compact

干预措施: Oral Nutritional Supplements (Dietary Supplement)

Usual Care

No Intervention

Food Fortification

Experimental

Food Fortification

干预措施: Food fortification (Dietary Supplement)

结局指标

主要结局

Change in four-metre gait speed (m/s) following nutritional support

时间窗: Change from baseline to 12 weeks

次要结局

  • Change in weight (kg) following nutritional support(Change from baseline to 12 weeks)
  • Change in fat free mass index (kg/m2) as measured by bioelectrical impedence following nutritional support(Change from baseline to 12 weeks)
  • Change in fat free mass (kg) as measured by bioelectrical impedence following nutritional support(Change from baseline to 12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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