se of prehabilitation health care application (Preha)

Phase 1

Recruiting

• Conditions: Preoperative physical condition; Gastrointestinal cancer

• Registration Number: JPRN-jRCTs042220106
• Lead Sponsor: Onoe Shunsuke

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-19
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1)Patients who are planned to undergo highly invasive hepato-pancreato-biliary surgery or subtotal esophagectomy or other highly invasive gastrointestinal surgery.
2)Patients who have understood and agreed the concept of the study.
3)Patients who can manipulate smart phone.
4)Patients who have agreed to buy and intake amino acids and synbiotics supplements.
5)Age more than 20, both gender

Exclusion Criteria

1)Patients who can not do exercise due to physical problem.
2)Patients with congenital branched-chain amino acids metabolic disorder.
3)Patients who are allergy to amino acids supplement or synbiotics.
4)Patients who are required an emergent surgery or who are planned to undergo surgery within 14 days.
5)Patients with severe comorbid disease (such as cardiac, respiratory, renal, or hepatic disorder etc.). Depending on the decision of the investigators.
6)Patients with severe mental disorder.
7)Patients with cognitive disease.
8)Patients with high risk of falling.
9)Patients who are not eligible for the study by the investigators decision.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Completion rate of Nagoya University Prehabilitation Program (NUPP) using Preha<br>Completion rate will be evaluated by the followings:<br>a) average daily steps during waiting period for surgery<br>b) proportion of the days walking more than 5,000 steps per day per days of waiting period for surgery<br>c) number of squat per day<br>d) daily minutes of moderate vigorous physical activity

Secondary Outcome Measures

Name	Time	Method
1) Compare the change of exercise capacity, body composition and nutritional status after the prehabilitation.<br>2) Incidence of postoperative complications and length of hospital stay<br>3) Relationships between the extent of exercise and bowel movement and the Edmonoton score.<br>Note; The data of daily steps per day, incidence of postoperative complications, and length of hospital stay will be compared with those obtained from historical control (patients who underwent Nagoya University Prehabilitation Program) using propensity score matching.