Utilizing activity trackers to increase postoperative ambulation
| ISRCTN | ISRCTN96991582 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96991582 |
| Protocol serial number | N/A |
| Sponsor | Boston University Medical Center Institutional Review Board |
| Funder | Boston Medical Center Resident Quality Improvement Council (USA) |
- Submission date
- 17/06/2015
- Registration date
- 29/06/2015
- Last edited
- 22/07/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
We are investigating the use of activity trackers as a novel quality improvement strategy to increase postoperative ambulation (walking after surgery). Postoperative ambulation is frequently recommended in surgical guidelines, but often difficult for patients and hospital staff to comply with. Activity trackers have been successfully used in outpatient clinics as a motivation tool for ambulation and health monitoring, but have rarely been used in the inpatient surgical setting. This study aims to test how well activity trackers perform in increasing postoperative ambulation.
Who can participate?
Adult patients having an bariatric operation performed at our center ( that is, laparoscopic roux-n-y gastric bypass, laparoscopic adjustable gastric band, and laparoscopic sleeve gastrectomy).
What does the study involve?
All participants are given activity trackers and then randomly allocated into one of two groups. Those in group 1 are given feedback on the number of steps they tale. Those in group 2 do not receive this feedback. The number of steps taken each day is then compared between the two groups.
What are the possible benefits and risks of participating?
The benefits of participating are limited to the use of the activity trackers and there is no financial compensation for subjects. There are no major risks to wearing the activity trackers.
Where is the study run from?
Boston Medical Center (USA)
When is the study starting and how long is it expected to run for?
March 2015 to March 2016
Who is funding the study?
Boston Medical Center Resident Quality Improvement Council (USA)
Who is the main contact?
Dr Ryan Macht
Contact information
Public
88 East Newton Street, Collamore - C 500
Boston
02118
United States of America
 ORCID ID |
0000-0002-1944-1653 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-center randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Utilizing activity trackers to increase postoperative ambulation: a novel quality improvement strategy to quantify ambulation and decrease bariatric surgery complications |
| Study objectives | The goal of this study is to evaluate activity tracker feedback as a strategy to increase early ambulation after surgery and to assess the association of early mobility with postoperative outcomes. We hypothesize that feedback from activity trackers will increase postoperative ambulation and lead to decreased ambulation-relation complications. |
| Ethics approval(s) | Boston University Medical Center IRB, 28/01/2015, ref: H-33593 |
| Health condition(s) or problem(s) studied | Postoperative complications following bariatric surgery |
| Intervention | All subjects will receive an activity tracker following surgery with randomization into two groups: 1. Participants receive ambulation feedback as an inpatient 2. Participants do not receive any feedback |
| Intervention type | Device |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
Postoperative ambulation (average steps/day) |
| Key secondary outcome measure(s) |
1. Postoperative readmission or emergency department visit |
| Completion date | 31/03/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 150 |
| Key inclusion criteria | All patients undergoing any of the three bariatric operations performed at our center (laparoscopic roux-n-y gastric bypass, laparoscopic adjustable gastric band, and laparoscopic sleeve gastrectomy). |
| Key exclusion criteria | Patients undergoing revisional bariatric surgery or emergent/elective reoperations |
| Date of first enrolment | 01/03/2015 |
| Date of final enrolment | 01/03/2016 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Boston
MA 02118
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
