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Not Yet RecruitingNCT07456943

Prehabilitation to Enhance Preoperative Function in Elderly Undergoing Abdominal Malignancy Surgery

Prehabilitation to Enhance Preoperative Function in Elderly Undergoing Abdominal Malignancy Surgery: A Prospective Study at Siriraj Hospital

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
110 (estimated)
Sponsor
Siriraj Hospital · Academic / Other
Sex
All
Age
60 Years – 90 Years
Healthy volunteers
Not accepted

Summary

The goal of this observational study is to evaluate the effectiveness of the multimodal prehabilitation program at the Siriraj Integrated Preoperative and Prehabilitation Center (SiPAP) on improving preoperative walking capacity and functional status in patients undergoing elective intraabdominal cancer surgery. The main question it aims to answer is: \- Does the prehabilitation program lead to a significant change in 6-minute walk distance (6MWD) at preoperative admission as compared to at baseline assessment? Participants will receive the structured multimodal prehabilitation program, which represents the standard of care for patients in the ERAS protocol at the study site. Outcomes will be measured at preoperative admission and at 1 and 3 months after surgery.

Detailed description

Surgical resection remains the mainstay of treatment for patients with intraabdominal malignancies such as colorectal, gastric, hepatobiliary, and pancreatic cancers. However, patients with cancer often present with impaired physical function, malnutrition, sarcopenia, and psychological distress, which may negatively impact their ability to tolerate surgery and recover postoperatively. Intraabdominal cancer surgery, particularly major procedures, imposes significant physiological stress, and reduced preoperative physical fitness has been associated with poor postoperative outcomes, including longer length of stay, increased complications, and delayed return to baseline function. Prehabilitation, defined as the process of enhancing a patient's functional capacity before surgery to improve postoperative outcomes, has emerged as a promising strategy to address these challenges. Multimodal prehabilitation, typically involving aerobic and resistance exercise, nutritional optimization, and psychological support, has been shown to improve preoperative functional capacity, measured by objective tests such as the Six-Minute Walk Test (6MWT), and to enhance postoperative recovery. The 6MWT is a simple, reproducible tool that reflects integrated cardiopulmonary and musculoskeletal function, and it has been widely used as a functional assessment in the preoperative setting. A minimal clinically important difference (MCID) of 20-30 meters has been suggested in various populations.Studies in colorectal and upper gastrointestinal cancer surgery have demonstrated that prehabilitation can lead to meaningful improvements in 6MWT distance, muscle strength, and health-related quality of life before surgery. However, most existing studies have been conducted in Western countries, and there is limited data regarding the feasibility and benefits of prehabilitation in Asian populations, including Thailand, where differences in patient characteristics, healthcare systems, and cultural factors may influence outcomes. Furthermore, many prior studies have focused on postoperative endpoints, whereas preoperative functional improvement-as a modifiable, short-term goal-is less frequently studied despite its potential clinical and prognostic significance. This prospective observational cohort study aims to evaluate the effectiveness of the multimodal prehabilitation program at the Siriraj Integrated Preoperative and Prehabilitation Center (SiPAP) on improving preoperative walking capacity and functional status in patients undergoing elective intraabdominal cancer surgery. The SiPAP at Siriraj Hospital, Bangkok, Thailand, has incorporated this multimodal prehabilitation program as part of the standard of care within the Enhanced Recovery After Surgery (ERAS) protocol. The findings of this study will clarify the feasibility and clinical utility of implementing prehabilitation in Thai patients undergoing cancer surgery and may inform the design of future randomized controlled trials or support the development of evidence-based guidelines.

Conditions

Timeline

Start date
2026-03-01
Primary completion
2027-09-01
Completion
2027-12-01
First posted
2026-03-09
Last updated
2026-03-10

Source: ClinicalTrials.gov record NCT07456943. Inclusion in this directory is not an endorsement.