在接受非线性周期运动训练或神经肌肉电刺激的慢性阻塞性肺疾病患者中补充β-丙氨酸：两项随机、双盲、安慰剂对照试验的方案

Beta-alanine supplementation in patients with COPD receiving non-linear periodised exercise training or neuromuscular electrical stimulation: protocol of two randomised, double-blind, placebo-controlled trials.

作者信息

Meys Roy, Stoffels Anouk A F, de Brandt Jana, van Hees Hieronymus W H, Franssen Frits M E, Sillen Maurice J H, Wouters Emiel F M, Burtin Chris, Klijn Peter, Bij de Vaate Eline, van den Borst Bram, Otker Jacqueline M, Donkers Jos, Schleich Florence N, Hayot Maurice, Pomiès Pascal, Everaert Inge, Derave Wim, Spruit Martijn A

机构信息

Department of Research and Development, CIRO, Horn, The Netherlands

NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht, The Netherlands.

出版信息

BMJ Open. 2020 Sep 13;10(9):e038836. doi: 10.1136/bmjopen-2020-038836.

DOI:10.1136/bmjopen-2020-038836

PMID:32928863

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7488791/

Abstract

INTRODUCTION

Exercise intolerance is common in patients with chronic obstructive pulmonary disease (COPD) and, although multifactorial, it is largely caused by lower-limb muscle dysfunction. Research has shown that patients with severe to very severe COPD have significantly lower levels of muscle carnosine, which acts as a pH buffer and antioxidant. Beta-alanine (BA) supplementation has been shown to consistently elevate muscle carnosine in a variety of populations and may therefore improve exercise tolerance and lower-limb muscle function. The primary objective of the current studies is to assess the beneficial effects of BA supplementation in enhancing exercise tolerance on top of two types of exercise training (non-linear periodised exercise (NLPE) training or neuromuscular electrical stimulation (NMES)) in patients with COPD.

METHODS AND ANALYSIS

Two randomised, double-blind, placebo-controlled trials have been designed. Patients will routinely receive either NLPE (BASE-TRAIN trial) or NMES (BASE-ELECTRIC trial) as part of standard exercise-based care during their 8-to-10 week pulmonary rehabilitation (PR) programme. A total of 222 patients with COPD (2×77 = 154 patients in the BASE-TRAIN trial and 2×34 = 68 patients in the BASE-ELECTRIC trial) will be recruited from two specialised PR centres in The Netherlands. For study purposes, patients will receive 3.2 g of oral BA supplementation or placebo per day. Exercise tolerance is the primary outcome, which will be assessed using the endurance shuttle walk test (BASE-TRAIN) or the constant work rate cycle test (BASE-ELECTRIC). Furthermore, quadriceps muscle strength and endurance, cognitive function, carnosine levels (in muscle), BA levels (in blood and muscle), markers of oxidative stress and inflammation (in blood, muscles and lungs), physical activity and quality of life will be measured.

ETHICS AND DISSEMINATION

Both trials were approved by CMO Regio Arnhem-Nijmegen, The Netherlands (NL70781.091.19. and NL68757.091.19).

TRIAL REGISTRATION NUMBER

NTR8427 (BASE-TRAIN) and NTR8419 (BASE-ELECTRIC).

摘要

引言

运动不耐受在慢性阻塞性肺疾病（COPD）患者中很常见，尽管其病因是多因素的，但主要是由下肢肌肉功能障碍引起的。研究表明，重度至极重度COPD患者的肌肉肌肽水平显著降低，肌肽具有pH缓冲和抗氧化作用。补充β-丙氨酸（BA）已被证明能持续提高各种人群的肌肉肌肽水平，因此可能改善运动耐量和下肢肌肉功能。当前研究的主要目的是评估在两种运动训练（非线性周期运动（NLPE）训练或神经肌肉电刺激（NMES））基础上，补充BA对提高COPD患者运动耐量的有益效果。

方法与分析

设计了两项随机、双盲、安慰剂对照试验。在为期8至10周的肺康复（PR）计划中，患者将常规接受NLPE（基础训练试验）或NMES（基础电刺激试验）作为基于标准运动的护理的一部分。将从荷兰的两个专业PR中心招募总共222例COPD患者（基础训练试验中2×77 = 154例患者，基础电刺激试验中2×34 = 68例患者）。为研究目的，患者将每天接受3.2克口服BA补充剂或安慰剂。运动耐量是主要结局，将使用耐力穿梭步行试验（基础训练试验）或恒定工作率自行车试验（基础电刺激试验）进行评估。此外，还将测量股四头肌力量和耐力、认知功能、肌肽水平（肌肉中）、BA水平（血液和肌肉中）、氧化应激和炎症标志物（血液、肌肉和肺部中）、身体活动和生活质量。