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

NCT06510088 | Completed DMC

• 1 other identifier: TaizhouHospital
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Elderly; Frail; Gastric Cancer; Prehabilitation

Outcome Measures

Primary Outcomes (2)

• postoperative complications

  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)

  30-day after surgery

• 6-minute walking distance (6MWD)

  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.

  30-day after surgery3-month after surgery

Secondary Outcomes (4)

• recovery of gastrointestinal function

  30 days after surgery

• QoL

  3-month after surgery

• physical activity

  3-month after surgery

• psychological status

  3-month after surgery

Study Arms (2)

3-week multimodal prehabilitation program+perioperative care guided by ERAS protocols

EXPERIMENTAL

This program included four components: aerobic and resistance exercises, respiratory training, nutritional counseling with whey protein supplementation, and psychological adjustment.

Procedure: 3-week multimodal prehabilitation program

perioperative care guided by ERAS protocols

NO INTERVENTION

Perioperative care of the control group was based on standardized ERAS recommendations that have been widely implemented to minimize heterogeneity in perioperative care. Typically, participants did not receive any preoperative interventions related to exercise, nutrition, or mental health.

Interventions

3-week multimodal prehabilitation program PROCEDURE

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.

3-week multimodal prehabilitation program+perioperative care guided by ERAS protocols

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University: lead

Study Sites (1)

Taizhou Hospital of Zhejiang Province Affiliated to Wenzhou Medical University

Taizhou, Zhejiang, China

Location

Related Publications (1)

• Chen J, Hong C, Chen R, Zhou M, Lin S. Prognostic impact of a 3-week multimodal prehabilitation program on frail elderly patients undergoing elective gastric cancer surgery: a randomized trial. BMC Gastroenterol. 2024 Nov 11;24(1):403. doi: 10.1186/s12876-024-03490-7.

  PMID: 39528916 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Senbin Lin

  Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General Surgery

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 19, 2024
• Study Start: March 1, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)