NCT06510088

Effects of Multimodal Prehabilitation on Frail Elderly Patients Undergoing Elective Gastric Cancer Surgery

Prognostic Impact of a 3-week Multimodal Prehabilitation Program on Frail Elderly Patients Undergoing Elective Gastric Cancer Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

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 consisting of preoperative physical therapy, nutritional support, and cognitive exercises decreases postoperative complications and improves functional recovery in frail elderly patients undergoing gastric cancer surgery, in comparison to usual clinical care.

Detailed description

Gastric cancer remains a significant health concern globally, especially among elderly individuals, where it poses a considerable burden due to its aggressive nature and limited therapeutic options. Population aging, a result of demographic transition, presents a critical societal challenge. According to a 2022 report by the World Health Organization (WHO), the median age for gastric cancer diagnosis is 69 years, with patients over 75 years facing heightened risks of morbidity and mortality. Although surgical resection remains the primary treatment for gastric cancer, the proportion of elderly patients undergoing surgery declines with age due to preoperative frailty. Frailty, marked by age-related declines in energy, muscle strength, weight, and activity levels, is common among elderly gastric cancer patients and correlates with poorer surgical outcomes, including higher morbidity and mortality. Therefore, interventions aimed at enhancing the functional status and resilience of frail elderly patients undergoing surgery for gastric cancer are critically important. Numerous studies have demonstrated that prehabilitation can diminish complications, hospital readmissions, length of hospital stay (LOS), and care dependence by enhancing functional reserve. However, these studies did not differentiate between age groups and frailty status, making it difficult to interpret the relationship between the outcomes and advanced age or frailty. It is hypothesized that patients at higher risk for postoperative complications, such as frail elderly individuals, are more likely to benefit from prehabilitation. Nonetheless, conclusive evidence on multimodal rehabilitation specifically designed for this vulnerable population remains insufficient. Prehabilitation seeks to optimize patients' preoperative risk factors during the waiting period before surgery. This preoperative phase is a critical time to modify health behaviors to reduce the stress of surgery and enhance the recovery process. Multimodal prehabilitation encompasses various interventions, including physical exercise, nutritional optimization, and psychological support, aiming to bolster physiological reserve in anticipation of the expected adverse effects of surgery and to support the postoperative recovery of functional capacity, particularly in patients with lower preoperative fitness levels. Several studies have demonstrated that prehabilitation can diminish complications, hospital readmissions, LOS, and care dependence by enhancing functional reserve. However, during their research, the patients' age group and frailty status were not differentiated, and the relationship between the results and advanced age/frailty cannot be well interpreted. It is hypothesized that patients at higher risk for postoperative complications, such as frail elderly individuals, are more likely to benefit from prehabilitation. Nonetheless, definitive evidence on multimodal rehabilitation specifically tailored to this vulnerable population is lacking. Therefore, we implemented a randomized clinical trial to provide evidence regarding the potential advantages of multimodal prehabilitation on the outcomes of frail elderly patients undergoing elective gastric cancer surgery.

Conditions

• Elderly
• Frail
• Gastric Cancer
• Prehabilitation

Interventions

Type	Name	Description
PROCEDURE	3-week multimodal prehabilitation program	This program included four components: Aerobic and Resistance Exercises A designated physical therapist supervises the resistance exercises and offers corrective guidance. Training intensity was continuously monitored and fine-tuned based on Borg scale assessments. Respiratory Training Respiratory training was conducted using a respiratory trainer. Patients were instructed to engage in respiratory training at least three times daily, with each session lasting 10 minutes. Nutrition Intervention Those in the multimodal prehabilitation group received daily whey protein powder to ensure a recommended protein intake of 1.5 g/kg/d. Protein supplements were to be consumed within one hour of exercise to promote muscle synthesis. Psychological Intervention Anxiety-coping interventions included relaxation techniques and deep breathing exercises, administered in a one-to-one format by a nurse trained in psychological care.

Timeline

• Start date: 2019-03-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2024-07-19
• Last updated: 2024-07-19

Locations

1 site across 1 country: China