UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of a Nursing Model to Encourage Ambulation After Postoperative Gastrointestinal Surgery Based on the Perspective of the Daily Activities
Title of the study (Brief title)	Development of a Nursing Model to Encourage Ambulation After Postoperative Gastrointestinal Surgery Based on the Perspective of the Daily Activities
Region	Japan

Condition
Condition	Gastrointestinal surgery
Classification by specialty	Gastrointestinal surgery Nursing
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to verify the effects of an ambulation care program based on the perspective of the activities of daily living (daily activity promotion care) by comparing it with an ambulation care program focusing solely on walking (walking promotion care) and to develop a nursing model to promote ambulation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The number of steps taken, the number of times the patient left their bed, and the number of implemented activities of daily living over the first 3 postoperative days will be measured.
Key secondary outcomes	-Physical function, physical comfort, and psychological condition over the first 3 postoperative days -Incidence of postoperative complications -Length of postoperative hospital stay

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Target patients will receive either walking promotion care or daily activity promotion care from the day before surgery through the first 3 postoperative days by ward nurses. 1. Walking promotion care (ambulation care focusing on walking) 1) Day before surgery A patient pamphlet generally used at the target ward will be used to offer preoperative instructions. The following explanations will be given: (1) the process and flow during hospitalization and surgery, (2) types of postoperative tubes (e.g., intravenous line, surgical drain) inserted in patients' bodies, (3) pain relief using patient-controlled analgesia, (4) timing for postoperatively starting oral intake, and (5) timing for postoperative ambulation. For ambulation, patients will be informed that they will roll over in bed and sit up on the day after surgery and that they will start walking on postoperative day 1. 2) Postoperative days 1-3 (1) Ambulation start day: Postoperative day 1 (2) Establishment of goals with the patients: The degree of walking as an objective will be established (e.g., "walk XX times in the morning and afternoon" or "walk XX times along the corridor"). (3) Nursing support: The ward nurses will provide physical management support and make environmental adjustments so that patients can walk. (4) Confirm status of achievement: Patients' achievement status will be confirmed by the patients and nurses at the end of the day shift.
Interventions/Control_2	2. Daily activity promotion care (care for achieving ambulation through the activities of daily living) 1) Day before surgery In addition to the walking promotion care, a patient leaflet that was created by researchers will be handed out to the participants. It will explain the specific details of the activities of daily living that will be postoperatively performed and the expectation that the amount of time getting out of bed will be actively increased while starting these activities in stages. It will also explain that patients should bring items (such as books, PCs, and tools used for hobbies) from home that can be used while out of bed. Exactly where the patients will spend their time out of bed (such as chairs or lounge) will also be explained. 2) Postoperative days 1-3 (1) Ambulation start day: Postoperative day 1 (2) Establishment of goals with the patients: In addition to walking promotion care, goals for the activities of daily living, such as going to the toilet or eating while sitting up, will be established. (3) Nursing support: The ward nurse will provide physical management support and make environmental adjustments so that the patients can become ambulatory through restarting the activities of daily living, such as going to the toilet, eating, and bathing. (4) Confirm status of achievement: Patient' achievement status will be confirmed by the patients and nurses at the end of the day shift.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients scheduled to undergo gastrointestinal (excluding the esophagus) resection under general anesthesia
Key exclusion criteria	1. Preoperative impairment of the activities of daily living 2. Unable to have verbal communication 3. Disorders of consciousness 4. Postoperative admission to the intensive care unit (ICU) 5. Postoperative activity restrictions
Target sample size	50

Research contact person
Name of lead principal investigator	Masashi Katogi
Organization	St.Luke's International University
Division name	Graduate School of Nursing Science
Address	10-1 Akashi-cho Chuou-ku, Tokyo
TEL	03-3543-6391
Email	m-katogi@slcn.ac.jp

Public contact
Name of contact person	Masashi Katogi
Organization	St.Luke's International University
Division name	Graduate School of Nursing Science
Address	10-1 Akashi-cho Chuou-ku, Tokyo
TEL	03-3543-6391
Homepage URL
Email	m-katogi@slcn.ac.jp

Sponsor
Institute	St.Luke's International University
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 01 Day
Anticipated trial start date	2016 Year 04 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 04 Month 12 Day
Last modified on	2017 Year 05 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025160