A Double-Blind, Randomised, Placebo-Controlled Trial of Protein Supplementation to Enhance Exercise Capacity in Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Exercise capacity
研究概览
简要总结
Chronic obstructive pulmonary disease (COPD) is a common smoking-related lung disease.
Pulmonary Rehabilitation (PR) is a six-week supervised group exercise and education class. PR is an effective intervention in COPD to reduce symptoms, improve exercise performance and prevent exacerbation. Exercise intolerance/limitation is one of the commonest issues with COPD patients and this may be compounded by reduced muscle mass and malnutrition. COPD patients lose body weight and skeletal muscle mass which leads to muscle weakness and dysfunction, thus impacting functional ability and quality of life. Muscle weakness is caused by a prolonged sedentary lifestyle and voluntary immobilization. Importantly, being under-weight is associated with an increased risk of mortality in COPD.
Nutritional supplementation have been used to overcome malnutrition in COPD patients. It has been shown that nutritional support integrated with exercise training can improve exercise activity, decreased the risk of mortality, and improve muscle strength in undernourished COPD patients. However, uptake of nutritional supplementation during pulmonary rehabilitation, where the potential benefit may be greatest, has been limited by the absence of rigorous evidence-based studies supporting use.
Investigators want to investigate the effect of a nutritional supplement during a PR program on exercise capacity in COPD patients. Investigators will collect demographic data, distribute questionnaires, measure exercise performance, and some additional measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participant in both groups will received either the supplement or the placebo/ control products. Both products will be labelled the same way.
Investigator: someone not from the research team will run the randomisation and deliver the products to participants.
Outcome Assessor: will not be involved in the randomisation and will be blinded
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed COPD (post-bronchodilator forced vital capacity in one second: forced vital capacity ratio <0.7)
- •>10 smoking pack year history.
- •Enrolling on a pulmonary rehabilitation programme.
- •Age of 18 and above.
排除标准
- •Patients with any physical or mental health disorders preventing compliance with trial protocol.
- •Unable to communicate in English
- •Malabsorption syndrome
- •Unable to perform the Incremental Shuttle Walk Test
- •Patients already using other types of oral dietary supplement, under the care of a dietitian.
- •Galactosaemia (contraindication)
- •Known cow's milk protein allergy or lactose intolerance
- •BMI >30kg/m2 without recent weight loss of >5%
结局指标
主要结局
Exercise capacity
时间窗: 12 weeks
The difference in change of exercise capacity before and and after pulmonary rehabilitation between intervention and control groups measured by Incremental Shuttle Walk Test.
次要结局
- Peripheral muscle strength(12 weeks)
- Rectus femoris muscle cross-sectional(12 weeks)
- Body composition(12 weeks)
- Physical activity(14 days)
- intervention compliance(6 weeks)
- Food intake(12 weeks)
- Lower limb function(12 weeks)
- Malnutrition risk(12 weeks)
- Disability associated with breathlessness(12 weeks)
- Body weight(12 weeks)
- Health-related quality of life(12 weeks)
- Body circumferences(12 weeks)