The feasibility of an exercise intervention in males at risk of oesophageal adenocarcinoma: A randomized controlled trial

View/ Open
File version
Version of Record (VoR)
Author(s)
Winzer, Brooke M.
Paratz, Jennifer D.
Whitehead, Jonathan P.
Whiteman, David C.
Reeves, Marina M.
Griffith University Author(s)
Year published
2015
Metadata
Show full item recordAbstract
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, ...
View more >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/m2) 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, Creactive 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.
View less >
View more >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/m2) 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, Creactive 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.
View less >
Journal Title
PLoS One
Volume
10
Issue
2
Copyright Statement
© 2015 Winzer et al. 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
credited.
Subject
Clinical Sciences not elsewhere classified