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Safety, Feasibility and Effect of an Individualized Physical Activity Intervention for Gastric Cancer Patient Undergoing Minimally Invasive Gastrectomy: a Pilot Study

This study is currently recruiting participants.
Verified December 2012 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01751880
First received: December 12, 2012
Last updated: December 13, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Gastric Cancer Patient
 Behavioral: physical activity intervention

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • 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 [ Time Frame: 2 weeks and 10 weeks after gastrectomy ] [ Designated as safety issue: No ]

Estimated Enrollment: 28
Study Start Date: June 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise Group 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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01751880

Contacts
Contact: Woo Jin Hyung, MD +82-2-2228-2100 WJHYUNG@yuhs.ac

Locations
Korea, Republic of
Department of Surgery, Yonsei University College of Medicine, Seoul, Korea Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Woo Jin Hyung, MD     +82-2-2228-2100     WJHYUNG@yuhs.ac    
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01751880     History of Changes
Other Study ID Numbers: 4-2012-0221
Study First Received: December 12, 2012
Last Updated: December 13, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Yonsei University:
Gastric cancer, minimally invasive gastrectomy, Physical activity intervention

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on June 18, 2013