The Effect of Encouraging Patients Undergoing Obesity Surgery to Move on Physical Mobility, Recovery and Negative Effects of Surgery

NCT ID: NCT07068828

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-08-01

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.

Conditions

Physical Activity; Bariatric Surgery; Quality of Recovery; Mobilization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Mobilization Encouragement Group

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.

Group Type: EXPERIMENTAL

Mobilization Encouragement Protocol

Intervention Type: BEHAVIORAL

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.

Smart Watch for Physical Activity Monitoring

Intervention Type: BEHAVIORAL

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.

Standard Care Control Group

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.

Group Type: ACTIVE_COMPARATOR

Smart Watch for Physical Activity Monitoring

Intervention Type: BEHAVIORAL

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.

Interventions

Mobilization Encouragement Protocol

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.

Intervention Type: BEHAVIORAL

Smart Watch for Physical Activity Monitoring

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Postoperative Mobilization Program; Postoperative Mobilization Program

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• In any of the ASA IV and V groups according to the ASA Physical Condition Classification System,
• 6-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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TC Erciyes University

OTHER

Sponsor Role: lead

Responsible Party

Yunus Gökkaya

Nurse, MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hatice Yüceler Kaçmaz, Associate Professor Doctor

Role: STUDY_DIRECTOR

TC Erciyes University

Central Contacts

Yunus Gökkaya, Nurse, MSc

Role: CONTACT

yunuusgokkaya@gmail.com

+90 551 179 44 32

Other Identifiers

BAP-14157

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ERU-SBF-YG-01

Identifier Type: -

Identifier Source: org_study_id