Physical ActivityNCT07068828
The Effect of Encouraging Patients Undergoing Obesity Surgery to Move on Physical Mobility, Recovery and Negative Effects of Surgery
A study testing Mobilization Encouragement Protocol and Smart Watch for Physical Activity Monitoring in people with Physical Activity and Bariatric Surgery, run by TC Erciyes University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Physical Activity, Bariatric Surgery, Quality of Recovery
- What is being tested?
- Mobilization Encouragement Protocol and Smart Watch for Physical Activity Monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Mobilization Incentive Protocol Applied to Bariatric Surgery Patients on Physical Mobility, Recovery Quality and Complications
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.
- Being tested
- Mobilization Encouragement Protocol, Smart Watch for Physical Activity Monitoring
- Keywords
- bariatric surgery, physical activity, quality of recovery, mobilization
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobilization Encouragement ProtocolBehavioural
Also called Postoperative Mobilization Program
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 MonitoringBehavioural
Also called Postoperative Mobilization Program
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mobilization Encouragement Protocol; Behavioral: 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. Receives: Behavioral: Smart Watch for Physical Activity Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Postoperative 3 days
Secondary outcomes (2)
Quality of Recovery
Improvement in recovery quality assessed by the Quality of Recovery-15 (QoR-15) questionnaire on postoperative day 3.The QoR-15 consists of 15 items in which the patient evaluates pain, physical comfort, physical independence, psychological support and emotional state. Items 11, 12, 13, 14 and 15 are reverse scored. The total score of the unidimensional scale is calculated by summing the scores given for each item. The highest score that can be obtained from the scale is 150 and the lowest score is 0 (zero). A score close to 150 indicates a high quality of recovery
Measured: Postoperative day 3
Postoperative Complications
Reduction in postoperative complications (e.g., deep vein thrombosis, pulmonary complications, wound healing problems) evaluated using the Clavien-Dindo classification system within 3 days after surgery. In the study, early postoperative complications will be recorded in the Patient Follow-up Chart using the Clavien-Dindo (CD) classification system. According to the CD classification system, postoperative complications are classified into five grades (I-V). In the study, patients will be divided into 2 groups according to CD classification; minor complication group including CD classification grades I to II and major complication group including CD classification grades III to IV.
Measured: Postoperative 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunus Gökkaya, TC Erciyes University
- Investigators
- Hatice Yüceler Kaçmaz, Associate Professor Doctor, Study director, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07068828
- Sponsor's protocol ID
- ERU-SBF-YG-01
- Other IDs
- BAP-14157
- Status last verified
- Jul 2025
- First submitted
- 4 Jul 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mobilization Incentive Protocol Applied to Bariatric Surgery Patients on Physical Mobility, Recovery Quality and Complications
- ClinicalTrials.gov ID
- NCT07068828
- Acronym / sponsor ID
- ERU-SBF-YG-01
- Keywords
- bariatric surgery, physical activity, quality of recovery, mobilization
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobilization Encouragement Group | Experimental | Behavioral: Mobilization Encouragement Protocol, Behavioral: Smart Watch for Physical Activity MonitoringParticipants 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. |
| Standard Care Control Group | Active comparator | Behavioral: Smart Watch for Physical Activity MonitoringParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Over 18 years of age,
- Can speak and understand Turkish,
- No communication problems,
- Admitted to the clinic for bariatric surgery,
- undergoing elective surgery,
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobilization Encouragement ProtocolAlso: Postoperative Mobilization ProgramThis 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. | Behavioural | Mobilization Encouragement Group |
| Smart Watch for Physical Activity MonitoringAlso: Postoperative Mobilization ProgramParticipants 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. | Behavioural | Mobilization Encouragement Group, Standard Care Control Group |
Primary outcome
Physical Activity Level (Step Count)
Time frame: Postoperative 3 days
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
2 secondary outcomes
Quality of Recovery
Time frame: Postoperative day 3
Postoperative Complications
Time frame: Postoperative 3 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: No. There is no plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hatice Yüceler Kaçmaz, Associate Professor Doctor study director
TC Erciyes University
Questions about this trial
What is this clinical trial studying?
A study testing Mobilization Encouragement Protocol and Smart Watch for Physical Activity Monitoring in people with Physical Activity and Bariatric Surgery, run by TC Erciyes University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yunus Gökkaya, Nurse, MSc (+90 551 179 44 32, yunuusgokkaya@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity Level (Step Count) (time frame: Postoperative 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.