Cost Effectiveness Analysis and Clinical Outcome of Nutritional Rehabilitation on Physical Functioning and Cardiometabolic Risk Profile in COPD Patients With Muscle Atrophy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Skeletal muscle strength
研究概览
简要总结
To study in clinically stable Chronic Obstructive Pulmonary Disease (COPD) patients with muscle atrophy:
- The short-term effects of 4 months exercise training including nutritional supplementation versus exercise training alone on physical functioning (skeletal muscle strength and exercise capacity) and body composition.
- The long-term effects of 4 months of exercise training and nutritional supplementation followed by 8 months of nutritional counseling (with supplementation on advice) and feedback on physical activity level versus 4 months of exercise training and 8 months with feedback on physical activity level alone on physical functioning, body composition and cardiometabolic risk profile;
- The cost-effectiveness of exercise rehabilitation and nutritional intervention versus exercise rehabilitation alone.
详细描述
Rationale. Recent guidelines state that pulmonary rehabilitation should be part of integrated care of patients with COPD and not limited to end stage disease. The investigators hypothesize that clinically stable COPD patients muscle atrophy, irrespective of the severity of airflow obstruction, show more pronounced long-term improvement in physical functioning and cardiometabolic risk profile after a rehabilitation programme including nutritional intervention (supplementation and counseling) than after a pulmonary rehabilitation programme without nutritional intervention, at acceptable costs. Nutritional supplementation focuses on enhancing the efficacy of the exercise training. Nutritional counseling aims at maintaining energy balance and modulating cardiovascular disease risk.
Study design. The research aims will be addressed in a multi-centre, randomized, clinical trial.
Phase A, Rehabilitation (4 months):
- Group 1: Supervised exercise training and 3 placebo nutritional supplements daily
- Group 2: Supervised exercise training and 3 nutritional supplements daily
Phase B, Maintenance (8 months):
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic Obstructive Pulmonary Disease
- •Muscle atrophy (a FFMI under the sex- and age-specific 25th percentile FFMI values, assessed by DEXA)
- •Eligible for pulmonary rehabilitation
排除标准
- •COPD patients under the age of 18;
- •Allergy or intolerance to fish, milk or other components of the study product;
- •Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements;
- •Not able to stop current supplement use or if total use will be above safe upper limits;
- •Participation in any other study involving investigational or marketed products concomitantly or within two weeks prior to entry into the study;
- •Pregnancy;
- •Life threatening diseases like tuberculosis, carcinoma, AIDS (including HIV+), acute leukaemia etc.
研究组 & 干预措施
Group 1 (placebo control)
60 clinically stable COPD patients with muscle atrophy, eligible for out-patient pulmonary rehabilitation
干预措施: Placebo supplement (Dietary Supplement)
Group 1 (placebo control)
60 clinically stable COPD patients with muscle atrophy, eligible for out-patient pulmonary rehabilitation
干预措施: Feedback on physical activity level (Behavioral)
Group 2 (nutritional intervention)
60 clinically stable COPD patients with muscle atrophy, eligible for out-patient pulmonary rehabilitation
干预措施: Feedback on physical activity level (Behavioral)
Group 2 (nutritional intervention)
60 clinically stable COPD patients with muscle atrophy, eligible for out-patient pulmonary rehabilitation
干预措施: Dietary supplementation (Dietary Supplement)
Group 2 (nutritional intervention)
60 clinically stable COPD patients with muscle atrophy, eligible for out-patient pulmonary rehabilitation
干预措施: Nutritional counselling (Behavioral)
结局指标
主要结局
Skeletal muscle strength
时间窗: 0, 12 months
Skeletal muscle strength assessed by isokinetic dynamometry (Biodex®)
次要结局
- Dyspnoea(0, 4, 12, 15 months)
- Physical activity(0, 4, 12, 15 months)
- Cardiometabolic risk profile(0, 4, 12 months)
- Body composition(0, 4, 12 months)
- Health related quality of life(0, 4, 12, 15 months)
- Bone mass density(0, 4, 12 months)
- Exercise capacity(0, 4, 12 months)
- Plasma levels of supplemented (micro)nutrients(0, 4, 12 months)