Supervised exercise after oesophageal cancer surgery: the PERFECT multicentre randomized clinical trial

Abstract

Background: This study investigated whether a supervised exercise programme improves quality of life (QoL), fatigue and cardiorespiratory fitness in patients in the first year after oesophagectomy.

Methods: The multicentre PERFECT trial randomly assigned patients to an exercise intervention (EX) or usual care (UC) group. EX patients participated in a 12-week moderate- to high-intensity aerobic and resistance exercise programme supervised by a physiotherapist. Primary (global QoL, QoL summary score) and secondary (QoL subscales, fatigue and cardiorespiratory fitness) outcomes were assessed at baseline, 12 and 24 weeks and analysed as between-group differences using either linear mixed effects models or ANCOVA.

Results: A total of 120 patients (mean(s.d.) age 64(8) years) were included and randomized to EX (61 patients) or UC (59 patients). Patients in the EX group participated in 96 per cent (i.q.r. 92-100 per cent) of the exercise sessions and the relative exercise dose intensity was high (92 per cent). At 12 weeks, beneficial EX effects were found for QoL summary score (3.5, 95 per cent c.i. 0.2 to 6.8) and QoL role functioning (9.4, 95 per cent c.i. 1.3 to 17.5). Global QoL was not statistically significant different between groups (3.0, 95 per cent c.i. -2.2 to 8.2). Physical fatigue was lower in the EX group (-1.2, 95 per cent c.i. -2.6 to 0.1), albeit not significantly. There was statistically significant improvement in cardiorespiratory fitness following EX compared with UC (peak oxygen uptake (1.8 ml/min/kg, 95 per cent c.i. 0.6 to 3.0)). After 24 weeks, all EX effects were attenuated.

Conclusions: A supervised exercise programme improved cardiorespiratory fitness and aspects of QoL.

Trial registration: Dutch Trial Register NTR 5045 (www.trialregister.nl/trial/4942).

Fig. 1

CONSORT diagram of the PERFECT study. The study was conducted in nine Dutch hospitals: UMC Utrecht, Utrecht (2015–2019); Hospital Group Twente (ZGT), Almelo (2015–2019); Catharina Hospital, Eindhoven (2015–2019); St. Antonius Hospital, Nieuwegein (2015–2017); IJsselland Hospital, Capelle aan den IJssel (2015–2017); Radboud University Medical Centre, Nijmegen (2015–2019); Amsterdam UMC, Amsterdam (formerly Amsterdam VU Medical Centre (2015–2019) and AMC Amsterdam (2017–2019)); Erasmus MC, Rotterdam (2017–2019).

Fig. 2

Radar plots demonstrating changes from baseline to 12 and 24 weeks post baseline in quality of life and fatigue scores for participants randomized to the exercise and usual care groups. An asterisk indicates a statistically significant between-group difference. It should be noted that the scale of all QoL-symptom outcomes and fatigue outcomes were inverted to facilitate interpretability. An increase from baseline to 12 or 24 weeks post-baseline now indicates an improvement for all outcomes.

Fig. 3

Effects of the 12-week exercise intervention on QoL and fatigue 12 and 24 weeks post baseline for all participants and stratified for sex, type of surgery, subtype of carcinoma and time since surgery. Intention-to-treat mixed linear regression models were used to calculate differences between the exercise and usual care group at 12 and 24 weeks. Models were adjusted for the baseline value of the outcome and stratification factors. Between-group differences were based on participants for whom measurements at 12 or 24 weeks were available (EX: open surgery n = 5; minimal invasive n = 49; <6 months n = 36; ≥6 months n = 18, men n = 46; women n = 8, adenocarcinoma n = 45 and squamous cell carcinoma n = 8, UC: open surgery n = 6; minimal invasive n = 50; <6 months n = 39; ≥6 months n = 17; men n = 49; women n = 7; adenocarcinoma n = 41; squamous cell carcinoma n = 10). Blue zones show the cut-off for clinically relevant (i.e., ≥10 points for QoL and ≥2 for fatigue⁵¹) changes. Between-group differences are shown with corresponding 95 per cent confidence intervals. Confidence intervals not including 0 are considered statistically significant.