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

February 6, 2024 updated by: Yonsei University
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Department of Surgery, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise group
Behavioral: exercise

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.
No Intervention: Usual care group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shorts Physical Performance Battery(SPPB)
Time Frame: "1 day before surgery", "POD3", "POD 1month"
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"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Hyoung-Il Kim, Department of Surgery, Yonsei University College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2023

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

January 24, 2024

First Submitted That Met QC Criteria

February 6, 2024

First Posted (Estimated)

February 15, 2024

Study Record Updates

Last Update Posted (Estimated)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2022-0208

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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