Feasibility, safety and preliminary effect of exercise prehabilitation in patients with esophageal cancer undergoing surgery: an open-label, randomized, parallel-group pilot and feasibility study.

Abstract

Background: Increasing evidence underscores the effectiveness of prehabilitation in improving postoperative outcomes in patients with cancer. However, evidence on structured exercise prehabilitation, specifically for functional recovery after esophagectomy, remains limited. Hence, this pilot study aimed to examine the feasibility and safety of a one-week exercise prehabilitation protocol and to explore its preliminary effects on functional capacity in patients with esophageal cancer undergoing surgery.

Methods: This is a parallel-group, randomized, open-label, pragmatic pilot trial. Patients with esophageal cancer awaiting surgery were randomly assigned to either the prehabilitation group or the control group. The prehabilitation group received a one-week structured exercise prehabilitation program that included respiratory, resistance and aerobic exercise before surgery, whereas the control group received no preoperative intervention. Feasibility was evaluated by the eligibility rate, recruitment rate, follow-up assessment rate, and exercise adherence rate. Safety was assessed by monitoring and recording any serious adverse events that occurred during the exercise program. Preliminary efficacy was determined via changes in functional capacity, postoperative complications, and quality of life.

Results: Twenty-one patients were randomized, and 16 were included in the primary analysis. Prehabilitation is feasible, with a recognized eligibility rate (69%), recruitment rate (95%) and follow-up completion rate (76%). All (100%) participants attended each treatment session during the prehabilitation and postoperative rehabilitation phases. No serious adverse events were reported. A statistically significant improvement in the change in the 6-minute walking distance from baseline was found in the prehabilitation group after one week of prehabilitation intervention compared with the control group (P < 0.001). A significant interaction effect (group × time) was also observed (P = 0.011). There was no significant difference in the occurrence of postoperative complications between the groups. Prehabilitation also potentially improved the preoperative quality of life (P < 0.05).

Conclusions: The one-week structured exercise prehabilitation protocol is feasible and safe for esophagectomy patients and has the potential to enhance preoperative functional capacity and quality of life. These findings support further investigations in large-scale randomized controlled trials to validate the efficacy for clinical endpoints.

Trial registration: This trial was retrospectively registered with the Chinese Clinical Trial Registry on 25/09/2024 (ChiCTR2400090172).