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CompletedNCT01751880Updated Nov 28, 2017

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

An interventional study of physical activity intervention in Gastric Cancer Patient, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-11-28.

Sponsored by Yonsei University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Aug 2012, registered Dec 2012).
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
20 Years to 70 Years
Sex
All
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Study 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.

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Conditions studied

  • Gastric Cancer Patient

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Keywords

  • Gastric cancer, minimally invasive gastrectomy, Physical activity intervention
03

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's enrollment of 24 is below the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Exercise Group

    Behavioral: physical activity intervention

Interventions

  • Behavioralphysical 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.

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What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • Department of Surgery, Yonsei University College of Medicine, Seoul, Korea
    Seoul, 120-752, Korea, Republic of
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References and documents

Publications

  • Cho I, Son Y, Song S, Bae YJ, Kim YN, Kim HI, Lee DT, Hyung WJ. Feasibility and Effects of a Postoperative Recovery Exercise Program Developed Specifically for Gastric Cancer Patients (PREP-GC) Undergoing Minimally Invasive Gastrectomy. J Gastric Cancer. 2018 Jun;18(2):118-133. doi: 10.5230/jgc.2018.18.e12. Epub 2018 Apr 25. PubMed 29984062 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01751880
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Dec 18, 2012
Start date
Aug 8, 2012
Primary completion
Nov 5, 2013
Completion
Nov 5, 2013
Last update
Nov 28, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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