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research
The feasibility of an exercise intervention in males at risk of oesophageal adenocarcinoma: a randomized controlled trial
Authors
A Bouassida
A Bouassida
+73 more
A Kubo
A Nelson
A Steffen
AG Renehan
AJ Cameron
AP Polednak
AP Thrift
AP Vizcaino
AR Kristal
B Cornish
B Winzer
B Winzer
BJ Kendall
BJ Kendall
Brooke M. Winzer
C Duggan
C Friedenreich
C Garofalo
C Hur
CM Friedenreich
DA Corley
David C. Whiteman
DC Whiteman
DM Parkin
DR Mathews
EM van Soest
G Borg
H Hampel
HJ Stein
IG Fatouros
IJ Hickman
IL Beales
J Shang
JE Donnelly
JE Reseland
Jennifer D. Paratz
JJB Anderson
JM Howard
JM Huerta
JM Jakicic
John Green
Jonathan P. Whitehead
KS Courneya
KS Thomas
M Bluher
M Fasshauer
M Hamer
Marina M. Reeves
MF Leitzmann
MJ Dekker
ML Booth
O Ogunwobi
OM Thompson
OO Ogunwobi
P Beddy
P Sharma
P Somasundar
PC Hallal
PH Black
PT Katzmarzyk
R Jones
RC Fitzgerald
RE Glasgow
RJ MacInnis
RK Semple
RV Lord
S Singh
SE Borst
T Byers
TI Ibiebele
V Vu
VB O’Leary
WJ Blot
Publication date
1 January 2015
Publisher
'Public Library of Science (PLoS)'
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on
PubMed
Abstract
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, 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. © 2015 Winzer et al
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