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The Feasibility of an Exercise Intervention in Males at Risk of Oesophageal Adenocarcinoma: A Randomized Controlled Trial

OBJECTIVE: To investigate the feasibility and safety of a 24-week exercise intervention, compared to control, in males with Barrett’s oesophagus, and to estimate the effect of the intervention, compared to control, on risk factors associated with oesophageal adenocarcinoma development. METHODS: A ra...

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Autores principales: Winzer, Brooke M., Paratz, Jennifer D., Whitehead, Jonathan P., Whiteman, David C., Reeves, Marina M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4338269/
https://www.ncbi.nlm.nih.gov/pubmed/25706622
http://dx.doi.org/10.1371/journal.pone.0117922
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author Winzer, Brooke M.
Paratz, Jennifer D.
Whitehead, Jonathan P.
Whiteman, David C.
Reeves, Marina M.
author_facet Winzer, Brooke M.
Paratz, Jennifer D.
Whitehead, Jonathan P.
Whiteman, David C.
Reeves, Marina M.
author_sort Winzer, Brooke M.
collection PubMed
description OBJECTIVE: To investigate the feasibility and safety of a 24-week exercise intervention, compared to control, in males with Barrett’s oesophagus, and to estimate the effect of the intervention, compared to control, on risk factors associated with oesophageal adenocarcinoma development. METHODS: A randomized controlled trial of an exercise intervention (60 minutes moderate-intensity aerobic and resistance exercise five days/week over 24 weeks; one supervised and four unsupervised sessions) versus attention control (45 minutes stretching five days/week over 24 weeks; one supervised and four unsupervised sessions) in inactive, overweight/obese (25.0–34.9 kg/m(2)) males with Barrett’s oesophagus, aged 18–70 years. Primary outcomes were obesity-associated hormones relevant to oesophageal adenocarcinoma risk (circulating concentrations of leptin, adiponectin, interleukin-6, tumour necrosis factor-alpha, C-reactive protein, and insulin resistance [HOMA]). Secondary outcomes included waist circumference, body composition, fitness, strength and gastro-oesophageal reflux symptoms. Outcomes were measured at baseline and 24-weeks. Intervention effects were analysed using generalised linear models, adjusting for baseline value. RESULTS: Recruitment was difficult in this population with a total of 33 participants recruited (target sample size: n = 80); 97% retention at 24-weeks. Adherence to the exercise protocol was moderate. No serious adverse events were reported. A statistically significant intervention effect (exercise minus control) was observed for waist circumference (-4.5 [95% CI -7.5, -1.4] cm; p < 0.01). Effects on primary outcomes were not statistically significant. CONCLUSION: This small, exploratory trial provides important information to inform future trial development including recruitment rates and estimates of effect sizes on outcomes related to oesophageal adenocarcinoma risk. Future trials should investigate a combined dietary and exercise intervention to achieve greater weight loss in this population and relax inclusion criteria to maximize recruitment. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12609000401257
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spelling pubmed-43382692015-03-04 The Feasibility of an Exercise Intervention in Males at Risk of Oesophageal Adenocarcinoma: A Randomized Controlled Trial Winzer, Brooke M. Paratz, Jennifer D. Whitehead, Jonathan P. Whiteman, David C. Reeves, Marina M. PLoS One Research Article OBJECTIVE: To investigate the feasibility and safety of a 24-week exercise intervention, compared to control, in males with Barrett’s oesophagus, and to estimate the effect of the intervention, compared to control, on risk factors associated with oesophageal adenocarcinoma development. METHODS: A randomized controlled trial of an exercise intervention (60 minutes moderate-intensity aerobic and resistance exercise five days/week over 24 weeks; one supervised and four unsupervised sessions) versus attention control (45 minutes stretching five days/week over 24 weeks; one supervised and four unsupervised sessions) in inactive, overweight/obese (25.0–34.9 kg/m(2)) males with Barrett’s oesophagus, aged 18–70 years. Primary outcomes were obesity-associated hormones relevant to oesophageal adenocarcinoma risk (circulating concentrations of leptin, adiponectin, interleukin-6, tumour necrosis factor-alpha, C-reactive protein, and insulin resistance [HOMA]). Secondary outcomes included waist circumference, body composition, fitness, strength and gastro-oesophageal reflux symptoms. Outcomes were measured at baseline and 24-weeks. Intervention effects were analysed using generalised linear models, adjusting for baseline value. RESULTS: Recruitment was difficult in this population with a total of 33 participants recruited (target sample size: n = 80); 97% retention at 24-weeks. Adherence to the exercise protocol was moderate. No serious adverse events were reported. A statistically significant intervention effect (exercise minus control) was observed for waist circumference (-4.5 [95% CI -7.5, -1.4] cm; p < 0.01). Effects on primary outcomes were not statistically significant. CONCLUSION: This small, exploratory trial provides important information to inform future trial development including recruitment rates and estimates of effect sizes on outcomes related to oesophageal adenocarcinoma risk. Future trials should investigate a combined dietary and exercise intervention to achieve greater weight loss in this population and relax inclusion criteria to maximize recruitment. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12609000401257 Public Library of Science 2015-02-23 /pmc/articles/PMC4338269/ /pubmed/25706622 http://dx.doi.org/10.1371/journal.pone.0117922 Text en © 2015 Winzer et al http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited.
spellingShingle Research Article
Winzer, Brooke M.
Paratz, Jennifer D.
Whitehead, Jonathan P.
Whiteman, David C.
Reeves, Marina M.
The Feasibility of an Exercise Intervention in Males at Risk of Oesophageal Adenocarcinoma: A Randomized Controlled Trial
title The Feasibility of an Exercise Intervention in Males at Risk of Oesophageal Adenocarcinoma: A Randomized Controlled Trial
title_full The Feasibility of an Exercise Intervention in Males at Risk of Oesophageal Adenocarcinoma: A Randomized Controlled Trial
title_fullStr The Feasibility of an Exercise Intervention in Males at Risk of Oesophageal Adenocarcinoma: A Randomized Controlled Trial
title_full_unstemmed The Feasibility of an Exercise Intervention in Males at Risk of Oesophageal Adenocarcinoma: A Randomized Controlled Trial
title_short The Feasibility of an Exercise Intervention in Males at Risk of Oesophageal Adenocarcinoma: A Randomized Controlled Trial
title_sort feasibility of an exercise intervention in males at risk of oesophageal adenocarcinoma: a randomized controlled trial
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4338269/
https://www.ncbi.nlm.nih.gov/pubmed/25706622
http://dx.doi.org/10.1371/journal.pone.0117922
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