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

Not Applicable

Completed

• Conditions: Elderly; Frail; Gastric Cancer; Prehabilitation
• Interventions: Procedure: 3-week multimodal prehabilitation program

• Registration Number: NCT06510088
• Lead Sponsor: Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

Brief 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.

Study Timeline

• Study Start: 2019-03-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-07
• Study First Submitted: 2024-07-15
• Study First Submitted QC: 2024-07-15
• Last Update Submitted: 2024-07-15
• Study First Posted: 2024-07-19
• Last Update Posted: 2024-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

1. Patients over the age of 65;
2. Patients with a Fried Frailty Index score of 2 or higher;
3. Patients who were scheduled for surgical resection of gastric adenocarcinoma;
4. Patients whose life expectancy was estimated by the surgeon to be greater than six months -

Exclusion Criteria

Patients were excluded from the study if they:

1. were scheduled for neoadjuvant therapy;
2. had metastatic cancer;
3. were unable to swallow or participate in exercise and fitness assessments due to pre-existing conditions (e.g., orthopedic, neuromuscular, or cardiorespiratory diseases);
4. had low compliance, defined as executing less than 70% of the weekly plan;
5. had incomplete data or were lost to follow-up. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3-week multimodal prehabilitation program+perioperative care guided by ERAS protocols	3-week multimodal prehabilitation program	This program included four components: aerobic and resistance exercises, respiratory training, nutritional counseling with whey protein supplementation, and psychological adjustment.

Primary Outcome Measures

Name	Time	Method
postoperative complications	30-day after surgery	30-day postoperative complications assessed by the Comprehensive Complication Index (CCI); The CCI, a validated index for assessing morbidity and mortality, aggregates all complications using the Clavien-Dindo classification system, resulting in a score from 0 (no complications) to 100 (death)
6-minute walking distance (6MWD)	30-day after surgery3-month after surgery	Functional capacity was assessed using the 6-MWD, a reliable measure of exercise tolerance in patients undergoing colorectal surgery, with changes of at least 20 meters deemed clinically significant.

Secondary Outcome Measures

Name	Time	Method
recovery of gastrointestinal function	30 days after surgery	recovery of gastrointestinal function
QoL	3-month after surgery	QoR-9 scale
psychological status	3-month after surgery	Hospital Anxiety and Depression scale
physical activity	3-month after surgery	Short Form (36) health survey (SF-36)

Trial Locations

Locations (1)

Taizhou Hospital of Zhejiang Province Affiliated to Wenzhou Medical University; 🇨🇳 Taizhou, Zhejiang, China