UMIN-CTR Clinical Trial

Public title

A study for the use of prehabilitation health care application (Preha) in patients undergoing gastrointestinal surgery (Preha trial)

Acronym

Use of prehabilitation health care application (Preha) (Preha trial)

Scientific Title

A study for the use of prehabilitation health care application (Preha) in patients undergoing gastrointestinal surgery (Preha trial)

Scientific Title:Acronym

Use of prehabilitation health care application (Preha) (Preha trial)

Region

Japan

Condition

Patients who are planning to undergo highly invasive gastrointestinal surgery

Classification by specialty

Surgery in general	Gastrointestinal surgery	Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To estimate the feasibility of prehabilitation health care application (PreHA) in patients undergoing highly invasive gastrointestinal surgery.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

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

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

YES

Dynamic allocation

NO

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Use of prehabilitation application (PreHA) .
Term; 2-6 weeks (while waiting for surgery)

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key 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

Key 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.

Target sample size

240

Name of lead principal investigator

1st name	Shunsuke
Middle name
Last name	Onoe

Organization

Nagoya University

Division name

Surgery I

Zip code

466-8550

Address

65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan

TEL

0527442218

Email

sonoe@med.nagoya-u.ac.jp

Name of contact person

1st name	Yukihiro
Middle name
Last name	Yokoyama

Organization

Nagoya University

Division name

Department of Surgery, Division of Perioperative Medicine

Zip code

466-8550

Address

65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan

TEL

0527442218

Homepage URL

Email

yyoko@med.nagoya-u.ac.jp

Institute

Nagoya University

Institute

Department

Personal name

Organization

Nagoya Univertsity

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Nagoya University Ethics Committee

Address

65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan

Tel

0527442479

Email

ethics@med.nagoya-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2022

Year

01

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2021

Year

10

Month

10

Day

Date of IRB

Anticipated trial start date

2022

Year

11

Month

01

Day

Last follow-up date

2029

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2021

Year

10

Month

10

Day

Last modified on

2022

Year

08

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052182