The Effect of Post-operative Exercise in Gastric Cancer Patients: A Randomized Controlled Trial (RCT) Study

NCT06260293 | Completed

• 1 other identifier: 4-2022-0208
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Medical advancements are enhancing the survival rates of individuals with gastric cancer. The growing population of gastric cancer survivors underscores the importance of managing treatment-related after-effects and side effects. Diminished physical function in cancer patients, particularly following gastric cancer surgery, is linked to increased mortality. The substantial decline in physical activity post-surgery contributes to a notable reduction in cardiorespiratory fitness and lower extremity muscle strength. Early postoperative exercise has demonstrated positive outcomes in colorectal cancer patients, facilitating early hospital discharge and supporting long-term recovery. However, there is a paucity of research on the efficacy of early postoperative exercise in the context of gastric cancer. Therefore, this study aims to evaluate the impact of early postoperative exercise on physical function following gastric cancer surgery.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Shorts Physical Performance Battery(SPPB)

  SPPB is an objective measurement instrument of balance, lower extremity strength, and functional capacity. instrument of balance, lower extremity strength, and functional capacity. The test includes three different domains (walking, sit-to-stand and balance) to assess functional mobility.

  "1 day before surgery", "POD3", "POD 1month"

Study Arms (2)

Exercise group

EXPERIMENTAL

Behavioral: exercise

Usual care group

NO INTERVENTION

Interventions

exercise BEHAVIORAL

A total of 4 exercise interventions. Twice In-patient exercise interventions: exercises on the ward at POD1, and POD2, and Recommended walking and stretching. Twice home-based exercise interventions: post-discharge, Recommended 30 minutes of low to moderate-intensity walking and daily bodyweight exercises per day(150 minutes each week). and remote exercises 1 per week.

Exercise group

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult men and women 19 years of age or older
• Pathologically diagnosed gastric cancer
• Able to undergo radical resection (R0)
• Scheduled for minimally invasive surgery (MIS)

You may not qualify if:

• Pregnant or lactating women
• Have received chemotherapy and radiation before surgery
• Scheduled for open surgery
• Subjects who do not understand or have not given informed consent
• If healthcare provider (primary care physician) deems it difficult for you to exercise

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Surgery, Yonsei University College of Medicine

Seoul, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Hyoung-Il Kim

  Department of Surgery, Yonsei University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 15, 2024
• Study Start: January 3, 2023
• Primary Completion: July 25, 2024
• Study Completion: July 25, 2024
• Last Updated: March 11, 2025

Record last verified: 2025-03

Locations

KR (1)