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Randomized Controlled Trial
. 2024 Nov 11;24(1):403.
doi: 10.1186/s12876-024-03490-7.

Prognostic impact of a 3-week multimodal prehabilitation program on frail elderly patients undergoing elective gastric cancer surgery: a randomized trial

Jianhui Chen  1 , Chen Hong  1 , Rui Chen  1 , Mengya Zhou  2 , Senbin Lin  3
Affiliations
Randomized Controlled Trial

Prognostic impact of a 3-week multimodal prehabilitation program on frail elderly patients undergoing elective gastric cancer surgery: a randomized trial

Jianhui Chen et al. BMC Gastroenterol. .

Abstract

Background: Research indicates that prehabilitation is effective in optimizing physical status before surgery, although this method may be considered "aggressive" for frail elderly patients. This study aimed to evaluate whether multimodal prehabilitation decreases postoperative complications and improves functional recovery in frail elderly patients undergoing gastric cancer surgery, in comparison to usual clinical care.

Methods: This study was a single-center, single-blind, randomized controlled trial. Patients over 65 years old with a Fried Frailty Index of 2 or higher, scheduled for gastric cancer surgery, were considered for inclusion. Eligible participants were randomized in a 1:1 ratio to either the intervention or control group. The intervention group underwent a 3-week multimodal prehabilitation program prior to surgery, in addition to perioperative care guided by ERAS protocols. The control group received only the latter. The primary outcome was the comprehensive complications index (CCI) measured at 30 days after surgery. Secondary outcomes included 30-day overall complications, functional walking capacity as assessed by 6-minute walking distance (6MWD) at 4 weeks postoperatively, and 3-month postoperative quality of life. This study was registered at ClinicalTrials.gov (No. NCT06510088).

Results: Among the 112 eligible patients, the median age was 74 years, with 58 (52.7%) being female. No between-group difference was found in the primary outcome measure, 30-day CCI. The Median (Q1-Q3) CCI for the intervention and control groups was 0 (0-12.2) and 0 (0-22.6) (P = 0.082), while the mean (SD) CCI was 6.1 (15.8) and 9.8 (12.7), respectively (P = 0.291). Notably, the incidence of severe complications (CCI > 20) was significantly lower in the intervention group compared to the control group (11.1% vs. 25.9%, P = 0.046), particularly in terms of medical complications (12.3% vs. 29.3%, P = 0.025). Preoperatively, 27 patients (47.4%) in the intervention group exhibited an increase in the 6MWD of at least 20 m, compared to 16 patients (27.6%) in the control group (P = 0.028). At 4 weeks postoperatively, more patients in the intervention group returned to their baseline 6MWD levels (63.2% vs. 43.1%, P = 0.031). Secondary parameters of functional capacity in the postoperative period generally favored the multimodal prehabilitation approach.

Conclusions: In frail elderly patients undergoing elective gastric cancer surgery, a prehabilitation program did not affect the 30-day postoperative complication rate or CCI but reduced severe complications and improved perioperative functional capacity.

Trial registration: [ClinicalTrials.gov], [NCT06510088], [07/15/2024], [Retrospectively registered].

Keywords: Elderly; Frail; Gastric cancer; Multimodal prehabilitation.

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Conflict of interest statement

Declarations Ethics approval and consent to participate The study was approved by the Institutional Review Board of Taizhou Hospital of Zhejiang Province Affiliated to Wenzhou Medical University. Informed consent was obtained from each participant before enrollment in the study. Consent for publication This is not applicable for this study. Competing interests The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Aerobic and resistance exercise guidance of the Intervention group and the Borg scale score. HR, heart rate
Fig. 2
Fig. 2
CONSORT Flow Diagram
See this image and copyright information in PMC

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