Oral nitrate supplementation to enhance pulmonary rehabilitation in COPD: ON-EPIC a multi-centre, double-blind, placebo-controlled, randomised parallel group study
| Autor: | Helen Jefford, Katrina J. Curtis, Adam Lewis, Rebecca Tanner, Winston Banya, Michael I. Polkey, Dinesh Shrikrishna, Bhavin Mehta, Matthew J Pavitt, Sara Buttery, Nicholas S Hopkinson, Karnan Satkunam, William D.-C. Man, SA Husain |
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| Přispěvatelé: | National Institute for Health Research, J P Moulton Charitable Foundation |
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Pulmonary and Respiratory Medicine
Male medicine.medical_specialty medicine.medical_treatment Respiratory System Administration Oral 030204 cardiovascular system & hematology Placebo chronic obstructive pulmonary disease 03 medical and health sciences Pulmonary Disease Chronic Obstructive 0302 clinical medicine Quality of life Double-Blind Method nitric oxide Internal medicine Medicine Humans Pulmonary rehabilitation Mass index Prospective Studies Exercise Aged COPD Nitrates Dietary nitrate supplementation Dose-Response Relationship Drug exercise business.industry 1103 Clinical Sciences Middle Aged medicine.disease Physical activity level Obstructive lung disease pulmonary rehabilitation Exercise Therapy Blood pressure Treatment Outcome 030228 respiratory system Dietary Supplements Quality of Life COPD pharmacology Female business Follow-Up Studies |
| Popis: | RationaleDietary nitrate supplementation has been proposed as a strategy to improve exercise performance, both in healthy individuals and in people with COPD. We aimed to assess whether it could enhance the effect of pulmonary rehabilitation (PR) in COPD.MethodsThis double-blind, placebo-controlled, parallel group, randomised controlled study performed at four UK centres, enrolled adults with Global Initiative for Chronic Obstructive Lung Disease grade II–IV COPD and Medical Research Council dyspnoea score 3–5 or functional limitation to undertake a twice weekly 8-week PR programme. They were randomly assigned (1:1) to either 140 mL of nitrate-rich beetroot juice (BRJ) (12.9 mmol nitrate), or placebo nitrate-deplete BRJ, consumed 3 hours prior to undertaking each PR session. Allocation used computer-generated block randomisation.MeasurementsThe 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.Results165 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 +60 m (10, 85) vs +30 m (0, 70), estimated treatment effect 30 m (95% CI 10 to 40); p=0.027. Active treatment also impacted on systolic blood pressure: treatment group −5.0 mm Hg (−5.0, –3.0) versus control +6.0 mm Hg (−1.0, 15.5), estimated treatment effect −7 mm Hg (95% CI 7 to −20) (pConclusionsDietary nitrate supplementation appears to be a well-tolerated and effective strategy to augment the benefits of PR in COPD.Trial registration numberISRCTN27860457. |
| Databáze: | OpenAIRE |
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