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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06260293
• Other study ID #: 4-2022-0208
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 3, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: February 2024
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 52
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Department of Surgery, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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"