The Effect of High Protein Diet in Combination With Physical Activity in the Rehabilitation of Patients With Chronic Obstructive Pulmonary Disease (COPD) at Risk of Malnutrition- a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- hand grip strenght
研究概览
简要总结
COPD outpatients with severe and very severe (grade III-IV) disease at risk of malnutrition commencing rehabilitation (7-10-week physical activity program) were randomized to receive a high protein diet (≥ 25 energy percentage) or standard care.
详细描述
Peripheral muscle function was measured by 6MWD (6-meter-walk-distance) and handgrip strength; FFM was measured by bioimpedance, mid upper arm circumference, and mid-thigh circumference; quality of life was measured by CAT (????); and dyspnoea was measured by the Medical Research Council dyspnoea scale and Borg scores at baseline and after 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed COPD stage III or stage IV
- •Nutritional risk by screening (NRS-2002)(Kondrup et al, 2002) and/or low-fat free mass (FFMI) (≤ 15% for women and ≤ 16% for men) measured by Bioelectrical Impedance Analysis (BIA)
排除标准
- •Terminal phase of COPD
- •Lung transplanted patients
- •Severe Comorbidities influenzing the end-points (pancreatic insufficiency, severe hepatic failure, inflammatory gastrointestinal disease)
- •Multiple sclerosis
- •Any unwillingness or inability (e.g. not able to make notes of their nutritional intake, come to consultations or manage oral intake)
结局指标
主要结局
hand grip strenght
时间窗: 7 weeks
kg
6-minute walk test (6MWD)
时间窗: 7 weeks
metres
次要结局
- Fat Free Mass (FFM)(7 weeks)
- Quality of life(7 weeks)
- Dyspnoea after 6 minutes walk(7 weks)
研究者
Jens Rikardt Andersen
Associate Professor, Primary Investigator
University of Copenhagen