Effects of the Association of L-arginine and Liposomal Vitamin C on Fatigue in COPD Patients With Chronic Respiratory Failure After Rehabilitation Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 3
- 主要终点
- Fatigue Severity Scale
研究概览
简要总结
The hypothesis that is being tested is that the supplementation of L-arginine plus Vitamin C to multidisciplinary pulmonary rehabilitation (PR) in patients with a previous diagnosis of chronic obstructive pulmonary disease (COPD) and chronic respiratory failure can have a favorable influence on fatigue and on clinical indicators related to endothelial function, potentially mitigating the cardiovascular (CV) disease burden in this clinical context.
详细描述
The primary objective of this project is to assess the effects of L-arginine plus Vitamin C supplementation on the physical outcomes in a group of COPD patients with chronic respiratory failure who underwent a 28-day PR program.
Eligible participants will be randomized using a random number generator in a 1:1 ratio to receive a twice-daily oral supplementation with either a combination of 1.66 g l-arginine plus 500 mg liposomal vitamin C (Bioarginina® C, Farmaceutici Damor, Naples, Italy) or a placebo for 28 days. Vials containing the active supplement or the placebo will be supplied by Farmaceutici Damor and will be made indistinguishable in appearance. All patients will undergo an intensive multidisciplinary PR program based on endurance and strength training. The main outcome of the study is the fatigue severity scale (FSS) total score after rehabilitation. Secondary outcomes include: 6-minute walking distance, forced expiratory volume in the first second (FEV1), COPD assessment test (CAT) score, endothelial function assessed through flow-mediated dilation (FMD), and muscular strength assessed through handgrip measurement.
Anthropometric, clinical, and functional characteristics of the study participants will be reported as mean ± standard deviation (SD) or median (interquartile range, IQR) for continuous variables and as absolute values (percentages) for categorical variables. Changes from baseline for continuous variables will be expressed as deltas (values at 28 days minus the values at baseline), and differences between the interventional groups will be evaluated using the Student's t-test for normally distributed variables or the Mann-Whitney U test for skewed variables.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD patients of both sexes complicated by respiratory failure (PaO2 inferior to 60 mmHg while breathing room air)
- •aged between 40 and 90 years selected from the inpatient/outpatient population admitted to perform a PR program in 12 Italian rehabilitation hospitals.
排除标准
- •consuming any ergogenic supplement in the last 2 months;
- •severe acute exacerbations in the 3 months before enrolment;
- •clinical instability (pH inferior to 7.35, hemodynamic instability, tachypnea at rest);
- •lung restrictive diseases;
- •primitive pulmonary hypertension;
- •recent lung thromboembolic events;
- •orthopaedic clinical conditions interfering with exercise;
- •coronary heart disease;
- •cardiac failure with reduced ejection fraction;
- •major cardiac arrhythmias;
- •neuromuscular diseases;
- •mini mental state examination (MMSE) <24;
- •any prior or current medical problem that would limit the subject participation
研究组 & 干预措施
L-arginine (arm 1)
Participants in this arm of the study will have an oral supplementation of l-arginine and liposomial vitamin C on a daily basis for 28 days.
干预措施: effect of L-arginine and liposomial vitamin C on pulmonary rehabilitation (Dietary Supplement)
Placebo (arm 2)
This arm will be given a placebo comparator on a daily basis for 28 days.
干预措施: placebo (Other)
结局指标
主要结局
Fatigue Severity Scale
时间窗: at baseline and after 28 days of intensive pulmonary rehabilitation
The Fatigue Severity Scale (FSS) is a 9-item scale that measures the severity of fatigue and how much it affects the person's activities and lifestyle in patients with a variety of disorders. The items are scored on a 7 point scale with 1=strongly disagree and 7=strongly agree. The minimum score=9 and maximum score possible=63. Higher the score=greater fatigue severity. More common way of scoring: mean of all the scores with minimum score being 1 and maximum score being 7. Mean (SD) FSS scores for healthy individuals; 2.3 (0.7). Cut-off score of 4 or more considered indicative of problematic fatigue.
次要结局
- Medical Research Council (MRC) for dyspnea test(at baseline and after 28 days of intensive pulmonary rehabilitation)
- Sit to stand test (STST)(at baseline and after 28 days of intensive pulmonary rehabilitation)
- Fractional exhaled nitric oxide (FeNO)(at baseline and after 28 days of intensive pulmonary rehabilitation)
- COPD Assessment Test (CAT)(at baseline and after 28 days of intensive pulmonary rehabilitation)
- Flow-mediated dilation (FMD);(at baseline and after 28 days of intensive pulmonary rehabilitation)
- Six minute walking test (6MWT)(at baseline and after 28 days of intensive pulmonary rehabilitation)
- Muscle Strength(at baseline and after 28 days of intensive pulmonary rehabilitation)