Elderly, Frail, Gastric Cancer, Prehabilitation
Conditions
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.
Interventions
PROCEDURE3-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.
Sponsors
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| recovery of gastrointestinal function | 30 days after surgery | recovery of gastrointestinal function |
| QoL | 3-month after surgery | QoR-9 scale |
| physical activity | 3-month after surgery | Short Form (36) health survey (SF-36) |
| psychological status | 3-month after surgery | Hospital Anxiety and Depression scale |
Countries
China
Outcome results
None listed