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.
Meys, Roy; Stoffels, Anouk A F; de Brandt, Janaet al.
chronic airways disease; nutrition & dietetics; rehabilitation medicine; respiratory medicine (see thoracic medicine); beta-Alanine; Dietary Supplements; Double-Blind Method; Electric Stimulation; Exercise; Exercise Therapy; Exercise Tolerance; Humans; Netherlands; Randomized Controlled Trials as Topic; Treatment Outcome; Pulmonary Disease, Chronic Obstructive/therapy; Quality of Life; Pulmonary Disease, Chronic Obstructive; Medicine (all); General Medicine
Abstract :
[en] [en] 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).
Disciplines :
General & internal medicine
Author, co-author :
Meys, Roy ; Department of Research and Development, CIRO, Horn, The Netherlands roymeys@ciro-horn.nl ; NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht, The Netherlands ; Department of Respiratory Medicine, Maastricht University Medical Centre (MUMC+), Maastricht, The Netherlands
Stoffels, Anouk A F; Department of Research and Development, CIRO, Horn, The Netherlands ; NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht, The Netherlands ; Department of Respiratory Medicine, Maastricht University Medical Centre (MUMC+), Maastricht, The Netherlands ; Department of Pulmonary Diseases, Radboud UMC Dekkerswald, Nijmegen, The Netherlands
de Brandt, Jana ; Reval Rehabilitation Research, Biomedical Research Institute, Faculty of Rehabilitation Sciences, Hasselt University, DIepenbeek, Belgium
van Hees, Hieronymus W H; Department of Pulmonary Diseases, Radboud UMC Dekkerswald, Nijmegen, The Netherlands
Franssen, Frits M E; Department of Research and Development, CIRO, Horn, The Netherlands ; NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht, The Netherlands ; Department of Respiratory Medicine, Maastricht University Medical Centre (MUMC+), Maastricht, The Netherlands
Sillen, Maurice J H; Department of Physiotherapy, CIRO, Horn, The Netherlands
Wouters, Emiel F M; Department of Research and Development, CIRO, Horn, The Netherlands ; NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht, The Netherlands ; Department of Respiratory Medicine, Maastricht University Medical Centre (MUMC+), Maastricht, The Netherlands
Burtin, Chris; Reval Rehabilitation Research, Biomedical Research Institute, Faculty of Rehabilitation Sciences, Hasselt University, DIepenbeek, Belgium
Klijn, Peter; Department of Pulmonology, Merem Pulmonary Rehabilitation Centre, Hilversum, The Netherlands ; Department of Pulmonary Medicine, Amsterdam UMC, Amsterdam, The Netherlands
Bij de Vaate, Eline; Department of Pulmonology, Merem Pulmonary Rehabilitation Centre, Hilversum, The Netherlands
van den Borst, Bram; Department of Pulmonary Diseases, Radboud UMC Dekkerswald, Nijmegen, The Netherlands
Otker, Jacqueline M; Patient Advisory Council, Lung Foundation Netherlands, Amersfoort, The Netherlands ; Client Council, CIRO, Horn, The Netherlands
Donkers, Jos; Client Council, CIRO, Horn, The Netherlands
Schleich, FLorence ; Centre Hospitalier Universitaire de Liège - CHU > > Service de pneumologie - allergologie
Hayot, Maurice; PhyMedExp, INSERM - CNRS, University of Montpellier - Montpellier CHU, Montpellier, France
Pomiès, Pascal; PhyMedExp, INSERM - CNRS, University of Montpellier - Montpellier CHU, Montpellier, France
Everaert, Inge; Department of Movement and Sport Sciences, University Ghent, Ghent, Belgium
Derave, Wim; Department of Movement and Sport Sciences, University Ghent, Ghent, Belgium
Spruit, Martijn A ; Department of Research and Development, CIRO, Horn, The Netherlands ; NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht, The Netherlands ; Department of Respiratory Medicine, Maastricht University Medical Centre (MUMC+), Maastricht, The Netherlands ; Reval Rehabilitation Research, Biomedical Research Institute, Faculty of Rehabilitation Sciences, Hasselt University, DIepenbeek, Belgium
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.
