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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01751880
Other study ID # 4-2012-0221
Secondary ID
Status Completed
Phase N/A
First received December 12, 2012
Last updated November 26, 2017
Start date August 8, 2012
Est. completion date November 5, 2013

Study information

Verified date November 2017
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Gastric cancer is a major health issue and one of the most common malignance in Korea. With the popularization of cancer screenings and increasing the average lifespan, the number of gastric cancer patients is increased. In the past, most of the research were concerned with survival and recovery after cancer surgery. However, as the medical technology had been developed and recovery rate and survival rate of cancer patients had risen, the patients wanted to return to a daily life and desire for participation for leisure. In other words, the patients who underwent surgery wants to maintain a high quality of life(QOL) level as like prior to cancer surgery.

There are many reports on the effect of the exercise program after cancer surgery. In addition, exercise program was associated with improving the QOL and functional recovery, decreasing a mood of depression, maintaining a muscle mass and improving the survival rate.

However, the subject patients of previous studies were Western people. Therefore, The results were not disclosed whether the exercise program suited to the body characteristics of Korean people. Furthermore there was no exercise program studies for the gastric cancer patients.

Medical service for cancer patients care should include not only diagnosis, treatment as like surgery but efforts on enhancing the quality of life. In other words, post-management education and management program as like exercise program are necessary for the cancer patients after surgery. So, the research about how to practice the exercise program and how to evaluate the effect on the recovery is needed.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date November 5, 2013
Est. primary completion date November 5, 2013
Accepts healthy volunteers No
Gender All
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria:

1. Early gastric cancer patients

2. Undergoing minimally invasive surgery

3. AGE: 20-70

4. ECOG: 0-1

5. A patient who did not exercise regularly for the last 6 months

6. A patient who signed the informed consent

Exclusion Criteria:

1. Pregnancy or plans to become pregnant

2. Cognitive disabilities

3. Other primary cancer history

4. History of major abdominal surgery except current surgery

5. Cardiopulmonary medical comorbidity

6. Living > 60 km from the hospital

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
physical activity intervention
Exercise program is scheduled to be conducted in three phases. Phase I is in-hospital exercise program. This program will be conducted in hospital during 1 week after surgery. Phase II is home-exercise program that will be performed at home during 1 week after discharge. Phase III is main-exercise program that will be conducted the fitness center nearby hospital during 8 weeks after phase II program. Main-exercise program is focused on the functional recovery.

Locations

Country Name City State
Korea, Republic of Department of Surgery, Yonsei University College of Medicine, Seoul, Korea 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 changes of result of blood sample test, cardio pulmonary function test and vital signs reflecting of inflammation level and nutrition condition in patients with minimally invasive gastrectomy 2 weeks and 10 weeks after gastrectomy