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

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 ca...

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Main Authors: Martijn A Spruit, Emiel F M Wouters, Eline bij de Vaate, Peter Klijn, Frits M E Franssen, Wim Derave, Chris Burtin, Florence N Schleich, Roy Meys, Anouk A F Stoffels, Jana de Brandt, Hieronymus W H van Hees, Maurice J H Sillen, Bram van den Borst, Jacqueline M Otker, Jos Donkers, Maurice Hayot, Pascal Pomiès, Inge Everaert
Format: Article
Language:English
Published: BMJ Publishing Group 2020-09-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/10/9/e038836.full
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author Martijn A Spruit
Emiel F M Wouters
Eline bij de Vaate
Peter Klijn
Frits M E Franssen
Wim Derave
Chris Burtin
Florence N Schleich
Roy Meys
Anouk A F Stoffels
Jana de Brandt
Hieronymus W H van Hees
Maurice J H Sillen
Bram van den Borst
Jacqueline M Otker
Jos Donkers
Maurice Hayot
Pascal Pomiès
Inge Everaert
author_facet Martijn A Spruit
Emiel F M Wouters
Eline bij de Vaate
Peter Klijn
Frits M E Franssen
Wim Derave
Chris Burtin
Florence N Schleich
Roy Meys
Anouk A F Stoffels
Jana de Brandt
Hieronymus W H van Hees
Maurice J H Sillen
Bram van den Borst
Jacqueline M Otker
Jos Donkers
Maurice Hayot
Pascal Pomiès
Inge Everaert
author_sort Martijn A Spruit
collection DOAJ
description 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).
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series BMJ Open
spelling doaj-art-4b2fa3c9c189459791f476297b8191e82025-01-09T00:25:09ZengBMJ Publishing GroupBMJ Open2044-60552020-09-0110910.1136/bmjopen-2020-038836Beta-alanine supplementation in patients with COPD receiving non-linear periodised exercise training or neuromuscular electrical stimulation: protocol of two randomised, double-blind, placebo-controlled trialsMartijn A Spruit0Emiel F M Wouters1Eline bij de Vaate2Peter Klijn3Frits M E Franssen4Wim Derave5Chris Burtin6Florence N Schleich7Roy Meys8Anouk A F Stoffels9Jana de Brandt10Hieronymus W H van Hees11Maurice J H Sillen12Bram van den Borst13Jacqueline M Otker14Jos Donkers15Maurice Hayot16Pascal Pomiès17Inge Everaert18NUTRIM School of Nutrition and Translational Research in Metabolism, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the NetherlandsDepartment of Respiratory Medicine, Maastricht University Medical Centre (MUMC+), Maastricht, The NetherlandsDepartment of Pulmonology, Merem Pulmonary Rehabilitation Centre, Hilversum, The Netherlands3 Merem Pulmonary Rehabilitation Center, Hilversum, NetherlandsNUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht, The NetherlandsDepartment of Movement and Sports Sciences, Ghent University, Ghent, BelgiumREVAL—Rehabilitation Research Center, Faculty of Rehabilitation Sciences, BIOMED Biomedical Research Institute, Hasselt University, Hasselt, BelgiumDepartment of Respiratory Medicine, CHU Sart-Tilman Liege, GIGA I3, Liege, BelgiumDepartment of Respiratory Medicine, Maastricht University Medical Centre (MUMC+), Maastricht, The Netherlands2 Department of Pulmonary Diseases, Radboud University Medical Center, Nijmegen, Gelderland, Netherlands1 Community Medicine and Rehabilitation, Physiotherapy, Umea University, Umea, Sweden2 Department of Pulmonary Diseases, Radboud University Medical Center, Nijmegen, Gelderland, NetherlandsDepartment of Physiotherapy, CIRO, Horn, The NetherlandsDepartment of Pulmonary Diseases, Radboud UMC Dekkerswald, Nijmegen, The NetherlandsPatient Advisory Council, Lung Foundation Netherlands, Amersfoort, The NetherlandsClient Council, CIRO, Horn, The NetherlandsPhyMedExp, INSERM – CNRS, University of Montpellier – Montpellier CHU, Montpellier, FrancePhyMedExp, INSERM – CNRS, University of Montpellier – Montpellier CHU, Montpellier, FranceDepartment of Movement and Sport Sciences, University Ghent, Ghent, BelgiumIntroduction 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).https://bmjopen.bmj.com/content/10/9/e038836.full
spellingShingle Martijn A Spruit
Emiel F M Wouters
Eline bij de Vaate
Peter Klijn
Frits M E Franssen
Wim Derave
Chris Burtin
Florence N Schleich
Roy Meys
Anouk A F Stoffels
Jana de Brandt
Hieronymus W H van Hees
Maurice J H Sillen
Bram van den Borst
Jacqueline M Otker
Jos Donkers
Maurice Hayot
Pascal Pomiès
Inge Everaert
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
BMJ Open
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
url https://bmjopen.bmj.com/content/10/9/e038836.full
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