Viewing Study NCT06510088



Ignite Creation Date: 2024-10-26 @ 3:35 PM
Last Modification Date: 2024-10-26 @ 3:35 PM
Study NCT ID: NCT06510088
Status: COMPLETED
Last Update Posted: None
First Post: 2024-07-15

Brief Title: Effects of Multimodal Prehabilitation on Frail Elderly Patients Undergoing Elective Gastric Cancer Surgery
Sponsor: None
Organization: None

Study Overview

Official Title: Prognostic Impact of a 3-week Multimodal Prehabilitation Program on Frail Elderly Patients Undergoing Elective Gastric Cancer Surgery
Status: COMPLETED
Status Verified Date: 2024-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 agefrailty 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None