Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
120 participants
INTERVENTIONAL
2023-01-31
2024-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The main questions it aims to answer are:
* Does pedometer-guided ambulation coaching increases ambulation after surgery?
* Does pedometer-guided coaching improve satisfaction, quality of recovery, while reducing postoperative complications?
Participants will be asked to install a pedometer app for the purpose of data sharing. Study personnel will compare pedometer follow-up plus text message coaching (intervention) with pedometer follow-up only (control) to investigate whether coaching improves adherence to the postoperative ambulation recommendation, and whether this leads to improvement of the secondary outcomes.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Step Home Trial: Utilising Physical Activity Data in the Acute Post-operative Setting
NCT02583711
Reducing Older Adults' Sedentary Behavior by Self-monitoring
NCT04003324
A Home-Based Prehabilitation Exercise Intervention for Improving Physical Function in Patients With Bladder Cancer and Upper Tract Urothelial Cancer, Get Moving Trial
NCT06040762
Exercise and Cognition Among Stroke Survivors
NCT06848998
Effects of a Weight Reduction and Lifestyle Program in Older Adults
NCT00714506
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This is a randomized controlled trial with a 1:1 allocation ratio. Participants will be randomly allocated to either pedometer follow-up (control) or pedometer follow-up with 3 times per week ambulation coaching through texts (intervention). Participants will be screened and consented before surgery. All recruited subjects will have a pedometer app installed on their phone during the preoperative clinic visit, during which the purpose of the app and potential risks will be explained.
After surgery and confirmation of the postoperative criteria, participants will enter the study and undergo randomization through a automated system.
Postoperatively , participants in the control arm will have pedometer data collected over postoperative days 8-30. The participants in the interventional arm will also have the pedometer data collected, while additionally being provided feedback in the form of text message every Monday, Wednesday and Friday.
Pedometer data:
The pedometer app utilized for this study is called "Outwalk" and it is designed by a third party. The study team has a research account on the pedometer app. During the screening visit, after downloading the app and creating the deidentified study subject account, the subject enables their data to be shared with the research account. This provides automatic access to the step count data. The study team will have access to subject data and the unblinded team member will check the steps count.
The following details will be collected from the medical record and/or directly from the participants: Age, Gender , Race and Ethnicity, Planned surgery, American Society of Anesthesiologists (ASA) classification, Insurance status, BMI, Charlson comorbidity score, smoking status (never, former, current), alcohol status (never, social, regular), substance use disorder (yes or no), reports of postoperative delirium, unplanned admissions to emergency room or unplanned hospital visits after surgery,
The following are collected from the participants: Postoperative recovery satisfaction (1-10), Sleep quality (1-10), pre and postoperative Duke Activity Status Index (0-58.2), technical issues with pedometer or app use (no, or yes with explanation), Quality of Recovery 15 score (0-150)
Sample size:
Based on prior findings from prior studies, this study is expected to enroll 120 subjects (60 subjects per arm), accounting for loss to follow-up or restrictions of primary outcome. In an inpatient exercising program for patients undergoing laparoscopic surgery, the intervention increased step goal adherence from 7% to 27% with a sample size of 58 subjects per arm, Using 1:1 allocation with p\<0.05 and power of 80%. In another study of open gynecology procedures; results showed the proportion of patients achieving activity goal (return to preoperative baseline) was 71% with pedometer-- based exercise intervention vs 41% control, with a sample size of 42 subjects per arm.
Participants who have missing data on more than 30% of the days will be removed from the study, their data will not be analyzed. Participants who have zero steps recorded for more than 30% of the days will also be treated as out-of-range results and will not be included in the primary analysis.
The investigation team plan to evaluate the distribution of the baseline characteristics between the two arms. Additional statistical analyses will be undertaken if there is significant baseline characteristics imbalance. Participants who have missing baseline data will be included in the primary and secondary analyses. The plan is to conduct a separate sensitivity analysis with these participants excluded. Participants with missing day 30 data will be included in the primary analyses. For such participants , any usable day-30 data will be included in the secondary analyses.
The primary analysis will compare the compliance with the ambulation goal between the coaching arm and the pedometer only arm. Compliance is defined as achieving at least 90% of the recommended ambulation goal (\>2,250 steps per day), this is to accommodate for daily variation in activities, as well as to accommodate for missed step recording.
For the evaluation of secondary outcomes, the day 30 outcomes between the coaching arm and the pedometer follow-up arm will be compared. Additionally, the following exploratory analyses are planned:
1. Day-30 outcomes in participants who reached the ambulation goal compared to those who did not, including participants in both arms
2. Comparing the changes in daily step count across time from day 8 to day 30
3. Sensitivity analysis of primary outcome, where participants with out-of-range results will be included.
4. Sensitivity analysis of primary outcome, where participants with missing baseline data will be excluded.
Participants who have missing baseline data will be included in the primary and secondary analyses. A separate sensitivity analysis will be conducted with these patients excluded.
Participants with missing day 30 data will be included in the primary analyses. For such participants, any usable day-30 data will be included in the secondary analyses.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
30-day interview will be done by a masked team member.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pedometer follow-up and coaching
Pedometer follow-up plus text message coaching Monday/ Wednesday/ Friday
Pedometer follow-up
The daily step count will be obtained from the patients using a pedometer app (OutWalk) from day 8 to day 30 after surgery.
Ambulation coaching
Patients will receive coaching text messages every Monday, Wednesday and Friday between day 8 and day 30 after surgery, based on a pre-fixed template.
Pedometer follow up
Pedometer follow-up from day 8- 30 after surgery
Pedometer follow-up
The daily step count will be obtained from the patients using a pedometer app (OutWalk) from day 8 to day 30 after surgery.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pedometer follow-up
The daily step count will be obtained from the patients using a pedometer app (OutWalk) from day 8 to day 30 after surgery.
Ambulation coaching
Patients will receive coaching text messages every Monday, Wednesday and Friday between day 8 and day 30 after surgery, based on a pre-fixed template.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subjects undergoing major abdominopelvic surgery under general anesthesia, expected to last more than 3 hours from induction of anesthesia to anesthesia stop time.
* Able to understand the study procedures and voluntarily provide study informed consent
* Agree to be followed up for the duration of the study period
* Has access to a smart phone with app compatibility
* Planned inpatient stay for 1 night or more
Exclusion Criteria
* Refusal to install the app/ deleted app before end of the monitor period
* Subjects who are unable to walk at baseline
* Medical contraindications for unrestricted ambulation
* Patients with spinal or lower limb pathology, chronic or poorly controlled pain potentially preventing full postoperative ambulation
* Neurological impairment precluding unrestricted ambulation Cognitive impairment precluding consent or follow up study activities
* BMI \>40
* Patients who require any mobility aid at baseline
* Subjects discharged to a rehab facility or never discharged from the hospital alive
* Hospital length of stay \> 1 week
* Patient not cleared by physical therapy for unrestricted ambulation on discharge
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Stony Brook University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sergio D. Bergese
Director of Outcomes and Clinical Research in Perioperative Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sergio D Bergese, MD, FASA
Role: PRINCIPAL_INVESTIGATOR
Stony Brook Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Stony Brook University Hospital
Stony Brook, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Hedrick TL, Hassinger TE, Myers E, Krebs ED, Chu D, Charles AN, Hoang SC, Friel CM, Thiele RH. Wearable Technology in the Perioperative Period: Predicting Risk of Postoperative Complications in Patients Undergoing Elective Colorectal Surgery. Dis Colon Rectum. 2020 Apr;63(4):538-544. doi: 10.1097/DCR.0000000000001580.
Nakajima H, Yokoyama Y, Inoue T, Nagaya M, Mizuno Y, Kayamoto A, Nishida Y, Nagino M. How Many Steps Per Day are Necessary to Prevent Postoperative Complications Following Hepato-Pancreato-Biliary Surgeries for Malignancy? Ann Surg Oncol. 2020 May;27(5):1387-1397. doi: 10.1245/s10434-020-08218-x. Epub 2020 Jan 23.
Bille A, Buxton J, Viviano A, Gammon D, Veres L, Routledge T, Harrison-Phipps K, Dixon A, Minetto MA. Preoperative Physical Activity Predicts Surgical Outcomes Following Lung Cancer Resection. Integr Cancer Ther. 2021 Jan-Dec;20:1534735420975853. doi: 10.1177/1534735420975853.
Jin Z, Lee C, Zhang K, Jeong R, Gan TJ, Richman DC. Utilization of Wearable Pedometer Devices in the Perioperative Period: A Qualitative Systematic Review. Anesth Analg. 2023 Apr 1;136(4):646-654. doi: 10.1213/ANE.0000000000006353. Epub 2023 Mar 16.
Wolk S, Linke S, Bogner A, Sturm D, Meissner T, Mussle B, Rahbari NN, Distler M, Weitz J, Welsch T. Use of Activity Tracking in Major Visceral Surgery-the Enhanced Perioperative Mobilization Trial: a Randomized Controlled Trial. J Gastrointest Surg. 2019 Jun;23(6):1218-1226. doi: 10.1007/s11605-018-3998-0. Epub 2018 Oct 8.
van Dijk-Huisman HC, Weemaes ATR, Boymans TAEJ, Lenssen AF, de Bie RA. Smartphone App with an Accelerometer Enhances Patients' Physical Activity Following Elective Orthopedic Surgery: A Pilot Study. Sensors (Basel). 2020 Aug 2;20(15):4317. doi: 10.3390/s20154317.
No JH, Kim K, Kim YB, Suh DH, Yang EJ, Hwang H, Yoo S. Effects of an activity tracker with feedback on physical activity in women after midline laparotomy: A randomized controlled trial. J Obstet Gynaecol Res. 2021 Jul;47(7):2544-2550. doi: 10.1111/jog.14807. Epub 2021 Apr 25.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB2022-00574
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.