Oral nitrate supplementation to enhance pulmonary rehabilitation in COPD: ON-EPIC a multi-centre, double-blind, placebo-controlled, randomised parallel group study
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Accepted version
Author(s)
Type
Journal Article
Abstract
Rationale Dietary nitrate supplementation has been proposed as a strategy to improve exercise performance, both in healthy individuals and in people with chronic obstructive pulmonary disease (COPD). We aimed to assess whether it could enhance the effect of pulmonary rehabilitation (PR) in COPD.
Methods This double-blind, placebo-controlled, parallel group, randomised controlled study performed at four UK centres, enrolled adults with GOLD grade II-IV COPD and MRC dyspnoea score 3-5 or functional limitation to undertake a twice weekly eight week PR programme. They were randomly assigned (1:1) to either 140mls of nitrate-rich beetroot juice (BRJ) (12.9mmol nitrate), or placebo nitrate-deplete BRJ, consumed three hours prior to undertaking each PR session. Allocation used computer generated block randomisation.
Measurements The primary outcome was change in incremental shuttle walk test (ISWT) distance. Secondary outcomes included quality of life, physical activity level, endothelial function via flow mediated dilatation, fat free mass index and blood pressure parameters.
Main Results 165 participants were recruited, 78 randomised to nitrate-rich BRJ and 87 randomised to placebo. Exercise capacity increased more with active treatment (n=57) than placebo (n=65); median (IQR) change in ISWT distance +60m (10, 85) vs. +30m (0, 70), (p = 0.027). Active treatment also impacted on systolic blood pressure: Treatment group -5.0mmHg (-5.0, -3.0) vs control +6.0mmHg (-1.0, 15.5) (p<0.0005). No significant serious adverse events or side effects were reported.
Conclusions Dietary nitrate supplementation appears to be a well-tolerated and effective strategy to augment the benefits of PR in COPD.
Methods This double-blind, placebo-controlled, parallel group, randomised controlled study performed at four UK centres, enrolled adults with GOLD grade II-IV COPD and MRC dyspnoea score 3-5 or functional limitation to undertake a twice weekly eight week PR programme. They were randomly assigned (1:1) to either 140mls of nitrate-rich beetroot juice (BRJ) (12.9mmol nitrate), or placebo nitrate-deplete BRJ, consumed three hours prior to undertaking each PR session. Allocation used computer generated block randomisation.
Measurements The primary outcome was change in incremental shuttle walk test (ISWT) distance. Secondary outcomes included quality of life, physical activity level, endothelial function via flow mediated dilatation, fat free mass index and blood pressure parameters.
Main Results 165 participants were recruited, 78 randomised to nitrate-rich BRJ and 87 randomised to placebo. Exercise capacity increased more with active treatment (n=57) than placebo (n=65); median (IQR) change in ISWT distance +60m (10, 85) vs. +30m (0, 70), (p = 0.027). Active treatment also impacted on systolic blood pressure: Treatment group -5.0mmHg (-5.0, -3.0) vs control +6.0mmHg (-1.0, 15.5) (p<0.0005). No significant serious adverse events or side effects were reported.
Conclusions Dietary nitrate supplementation appears to be a well-tolerated and effective strategy to augment the benefits of PR in COPD.
Date Issued
2020-05-06
Date Acceptance
2020-04-15
Citation
Thorax, 2020, 75, pp.547-555
ISSN
0040-6376
Publisher
BMJ Publishing Group
Start Page
547
End Page
555
Journal / Book Title
Thorax
Volume
75
Copyright Statement
© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.
Sponsor
National Institute for Health Research
J P Moulton Charitable Foundation
Identifier
https://thorax.bmj.com/content/75/7/547
Grant Number
BRU 6535
n/a
Subjects
COPD pharmacology
pulmonary rehabilitation
1103 Clinical Sciences
Respiratory System
Publication Status
Published
Date Publish Online
2020-05-06