a blinded interventional pilot study.

West MA; Loughney L;  Lythgoe D; Barben CP; Sripadam R; Kemp GJ; Grocott MP; Jack S,

British Journal Of Anaesthesia [Br J Anaesth], ISSN: 1471-6771, 2015 Feb; Vol.
114 (2), pp. 244-51;

Publisher: Oxford University Press; PMID: 25274049;

Background: Patients requiring surgery for locally advanced
rectal cancer often additionally undergo neoadjuvant chemoradiotherapy
(NACRT), of which the effects on physical fitness are unknown. The aim
of this feasibility and pilot study was to investigate the effects of
NACRT and a 6 week structured responsive exercise training programme
(SRETP) on oxygen uptake [Formula: see text] at lactate threshold
([Formula: see text]) in such patients.Methods: We prospectively
studied 39 consecutive subjects (27 males) with T3-4/N+ resection
margin threatened rectal cancer who completed standardized NACRT.
Subjects underwent cardiopulmonary exercise testing at baseline
(pre-NACRT), at week 0 (post-NACRT), and week 6 (post-SRETP).
Twenty-two subjects undertook a 6 week SRETP on a training bike (three
sessions per week) between week 0 and week 6 (exercise group). These
were compared with 17 contemporaneous non-randomized subjects (control
group). Changes in [Formula: see text] at [Formula: see text] over time
and between the groups were compared using a compound symmetry
covariance linear mixed model.Results: Of 39 recruited subjects, 22 out
of 22 (exercise) and 13 out of 17 (control) completed the study. There
were differences between the exercise and control groups at baseline
[age, ASA score physical status, World Health Organisation performance
status, and Colorectal Physiologic and Operative Severity Score for the
Enumeration of Mortality and Morbidity (CR-POSSUM) predicted
mortality]. In all subjects, [Formula: see text] at [Formula: see text]
significantly reduced between baseline and week 0 [-1.9 ml kg(-1)
min(-1); 95% confidence interval (CI) -1.3, -2.6; P<0.0001]. In the
exercise group, [Formula: see text] at [Formula: see text]
significantly improved between week 0 and week 6 (+2.1 ml kg(-1)
min(-1); 95% CI +1.3, +2.9; P<0.0001), whereas the control group values
were unchanged (-0.7 ml kg(-1) min(-1); 95% CI -1.66, +0.37;
P=0.204).

Conclusions: NACRT before rectal cancer surgery reduces
physical fitness. A structured exercise intervention is feasible
post-NACRT and returns fitness to baseline levels within 6
weeks.Clinical Trial Registration Nct: 01325909.