A randomised phaseII trial of preoperative exercise to reduce operative risk in gastric cancer patients with metabolic syndrome

UMIN ID: UMIN000000596

Registered date:07/02/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: metabolic syndrome gastric cancer
• Date of first enrollment: 2007/01/01
• Target sample size: 86
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Control group: Surgery alone Patient will be performed open gastrectomy/ total gastrectomy or laparoscopy-assisted distal/ toatl gastrectomy within 14 days after registration. Patients will receive the operation following the JGCA gastric cancer treatment guideline ver.2: standard gastrectomy or modified gastrectomy.
Intervention group: exercise followed by operation type: exercise duration: 4weeks frequency: aerobic exercise 3-7day/week, resistance training 1-2day/week, stretch 3-7day/week operation: same as control group

Outcome(s)

• Primary Outcome: Incidence of perioperative complications
• Secondary Outcome: Changes from the base-line body weight, HDL cholesterol, operation time, intaoperative blood loss, number of dissected lymph nodes, grade of perioperative complications

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1.Cannot exercise because of muscloskeletal disease 2.History of injury such as fracture within 6 months before registration 3.History or current therapy of bronchial asthma 4.History of severe pneumonia or bronchitis within 6 months before registration 5.History or current therapy of arrythmia to be treated 6.History of acute myocardial infarction within 6 months before registration 7.Uncontrolled DM (Insulin-treated patient is also applicable, if BS control is good.)

Related Information

• Primary Sponsor: AEGES study group
• Secondary Sponsor: NPO ECRIN
• Source(s) of Monetary Support: Kanagawa Health Foundation