NCT07068828

Brief Summary

Early mobilization and physical mobility have a critical role in minimizing complications after surgical procedures. Although there are a limited number of studies in the literature on the step count of bariatric surgery patients, there is no study focusing on interventions that promote mobilization in this patient group. The aim of this study was to determine the effect of a mobilization incentive protocol on physical mobility, quality of recovery and complications in patients undergoing bariatric surgery. This single-blind randomized controlled study will include 70 individuals who underwent bariatric surgery in the General Surgery ward of Kayseri City Hospital between July 2025 and June 2026. Patients will be followed up for 3 days after surgery, starting with the hospitalization process in the clinic before surgery. All participating patients will be administered preoperative patient information form, 6-minute walk test and International Physical Activity Questionnaire. Patients in the intervention group will be shown video-based mobilization training after bariatric surgery. The control group will not receive any intervention. Both groups will wear a smart watch at the time of the first mobilization (8th hour after surgery) and a patient follow-up form will be filled out. A reminder brochure will be hung in their rooms on the 1st postoperative day and a reminder text message will be sent to their cell phones on the 1st and 3rd days. The number of steps will be measured from the smart watch for three days postoperatively, complications will be followed according to the clavien dindo classification system and the Quality of Recovery-15 scale will be applied on the 3rd postoperative day. The analysis of the research data will be performed in IBM SPSS Statistics 26.0 package program. When comparisons between groups are made, parametric tests will be used in the analysis of data showing normal distribution in numerical data, and non-parametric tests will be used in the analysis of data not showing normal distribution. Chi-square test will be used in the analysis of categorical variables. The lack of protocols to increase mobilization emphasizes the importance and innovativeness of this study. The mobilization promotion protocol is expected to increase the physical activity level (number of steps) of bariatric surgery patients in the postoperative period, improve the quality of recovery and reduce complications. These findings will reveal the importance of mobilization incentive protocol by contributing to postoperative care strategies.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Aug 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress77%
Aug 2025Aug 2026

First Submitted

Initial submission to the registry

July 4, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 16, 2025

Completed
16 days until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

1 year

First QC Date

July 4, 2025

Last Update Submit

July 14, 2025

Conditions

Keywords

bariatric surgeryphysical activityquality of recoverymobilization

Outcome Measures

Primary Outcomes (1)

  • Physical Activity Level (Step Count)

    Increase in daily step count measured objectively by smart watches in bariatric surgery patients receiving the mobilization encouragement protocol. Xiaomi redmi watch 3 active smartwatch is used in the study.The battery lasts 12 days in normal use and 8 days in intensive use. The battery has a capacity of 298 mAh. Bluetooth 5.3 support. It connects to smartphones with Android 6.0 or iOS 12.0 and above versions. After connecting via Bluetooth, the number of steps taken during the day is recorded on the phone. The watch setup requires installing the Mi Fitness (Xiaomi Wear Lite) application and logging in. The application is paired with the QR code on the watch and the watch is connected to the phone via bluetooth. Before the patient is mobilized, the patients will be fitted with a smart watch and will be informed about the smart watch and reminded not to take it off. On postoperative day 1, day 2 and day 3, the smartwatch will be checked and the number of steps taken will be recorded

    Postoperative 3 days

Secondary Outcomes (2)

  • Quality of Recovery

    Postoperative day 3

  • Postoperative Complications

    Postoperative 3 days

Study Arms (2)

Mobilization Encouragement Group

EXPERIMENTAL

Participants in this group receive a mobilization encouragement protocol consisting of a video-based education session before surgery, visual reminders (posters) in their rooms on post-op day 1, and SMS reminders sent to their phones on post-op days 1 and 3. Participants will wear a smart watch starting 8 hours after surgery to track physical activity (step count). The goal is to increase early mobilization, improve recovery quality, and reduce postoperative complications.

Behavioral: Mobilization Encouragement ProtocolBehavioral: Smart Watch for Physical Activity Monitoring

Standard Care Control Group

ACTIVE COMPARATOR

Participants in this group receive routine postoperative care without additional mobilization encouragement. They will also wear a smart watch to monitor physical activity, but will not receive educational videos, posters, or SMS reminders. This group serves as a comparison to evaluate the effect of the mobilization protocol.

Behavioral: Smart Watch for Physical Activity Monitoring

Interventions

This intervention includes a video-based education session delivered before surgery to encourage early mobilization, visual poster reminders in patient rooms on postoperative day 1, and SMS text message reminders sent to patients' phones on postoperative days 1 and 3. Participants will also wear a smart watch starting 8 hours after surgery through postoperative day 3 to monitor physical activity (step count). The goal is to increase physical activity levels, improve recovery quality, and reduce postoperative complications after bariatric surgery.

Also known as: Postoperative Mobilization Program
Mobilization Encouragement Group

Participants in the control group receive standard postoperative care without additional mobilization encouragement. They wear a smart watch starting 8 hours after surgery through postoperative day 3 to monitor physical activity (step count). However, they do not receive video education, posters, or SMS reminders.

Also known as: Postoperative Mobilization Program
Mobilization Encouragement GroupStandard Care Control Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 18 years of age,
  • Can speak and understand Turkish,
  • No communication problems,
  • Admitted to the clinic for bariatric surgery,
  • undergoing elective surgery,
  • Who agreed to wear a smartwatch,
  • Smartphone users,
  • Individuals who volunteered to participate in the study and who do not have physical movement disabilities

You may not qualify if:

  • In any of the ASA IV and V groups according to the ASA Physical Condition Classification System,
  • min walk test contraindicated (unstable angina pectoris within the last month, systolic blood pressure above 180 mmHg, diastolic blood pressure above 100 mmHg, resting heart rate above 120),
  • Have any cognitive or neurological impairment that may adversely affect ambulation or cooperation,
  • Using a walking aid such as cane, walker, etc. while walking,
  • Have a disease that requires assistance with physical movement (e.g. after stroke, limb amputation)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Hatice Yüceler Kaçmaz, Associate Professor Doctor

    TC Erciyes University

    STUDY DIRECTOR

Central Study Contacts

Yunus Gökkaya, Nurse, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse, MSc

Study Record Dates

First Submitted

July 4, 2025

First Posted

July 16, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

July 16, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

There is no plan