Use of prehabilitation health care application (Preha)

JRCT ID: jRCTs042220106

Registered date:19/12/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Preoperative physical condition
• Date of first enrollment: 15/02/2023
• Target sample size: 30
• Study type: Interventional

Intervention(s)

Patients who are scheduled to undergo surgery download PreHabilitation Application (Preha) in their smart phone through QR cord. Patients are recommended to carry this smart phone while they are waiting for surgery. Preha records daily physical activities. In addition, patients are recommended to input the information of bowel movement (including the fecal condition by Bristol scale), intake of probiotics, prebiotics, and amino acids supplement, and Edmonton Symptom Assessment for cancer.

Preha guides patients to execute Nagoya University Prehabilitation Program (NUPP) while waiting for surgery.
They are also recommended to intake amino acids supplement (Aminoperfect Multisupport; 4 packets per day) and synbiotics (Supersynbiotics LBG-P; 2 packets of probiotics and 2 packets of prebiotics per day).

Outcome(s)

Primary Outcome

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

Secondary Outcome

1) Compare the change of exercise capacity, body composition and nutritional status after the prehabilitation.
2) Incidence of postoperative complications and length of hospital stay
3) Relationships between the extent of exercise and bowel movement and the Edmonoton score.
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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Onoe Shunsuke