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临床试验/NCT03923764
NCT03923764Unknown不适用

Effects of a Diet High in Protein and Energy in Combination With Physical Activity for the Improvement of Coughing Capacity in COPD Patients

University of Copenhagen2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2019年7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
48
试验地点
2
主要终点
Improvement of coughing capacity of COPD patients

研究概览

简要总结

Chronic Obstructive Lung Disease (COPD) is one of the leading death causes worldwide. COPD is a disease that is characterized by chronic inflammation which leads to irreversible damage of airways and lung tissue. This intervention investigates the effects of a diet high in protein and energy for the improvement of coughing capacity and lung function of COPD patients. The patients will be recruited as part of a lung rehabilitating programme which takes place in Bispebjerg and Hvidovre Hospital. The intervention group receives individual nutritional guidelines whereas the control group continues their usual diet. Blood tests will be performed at baseline and the end of the study. Other anthropometric measures include spirometry for lung function, hand grip strength and fat free mass to assess muscle waisting.

详细描述

40 patients with COPD randomized to diet with protein 1.3 g/kg/day or habitual intake:

Primary endpoint (before-after): Leicester Cough Questionnaire Secondary endpoints: ADL-score, no. daily cough periods, development in FEV1 and FVC, hand-grib-strenght, use of respiratory medications, smoking, appetite, admissions to hospital, antibiotics and/or steroids, oxygen saturation, FFM (BIA), Coughs tests in spirometer and peak-flow-meter

Study period: 2 months

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Diagnosed with COPD
  • Participating in ongoing lung rehabilitating programme at Hvidovre and Bispebjerg Hospital
  • over 18 years

排除标准

  • Plasma creatinin over 200 mikrog/l
  • unable to read or speak danish

研究组 & 干预措施

Intervention group

Experimental

1.3 g protein per kg bodyweight per day for 8 weeks

干预措施: High protein and energy diet (Dietary Supplement)

Kontrol group

Active Comparator

habitual diet

干预措施: Habitual Diet (Other)

结局指标

主要结局

Improvement of coughing capacity of COPD patients

时间窗: 8 weeks

Measured by a validated danish version of Leicester Cough Questionnaire (1-7 points)

次要结局

  • Weight change(8 weeks)
  • Oxygen saturation before and after treatment(8 weeks)

研究者

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

Jens Rikardt Andersen

Associate Professor

University of Copenhagen

研究点 (2)

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