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This study is a non-blinded randomized controlled trial. Consenting participants will be randomized to routine post-operative ambulation vs. goal-augmented post-operative care (they will be given a goal number of steps to take on each post-operative day) following in-patient gynecologic surgery.
This study is a non-blinded randomized controlled trial. Consenting participants will be randomized to routine post-operative ambulation vs. treadmill-augmented post-operative care (placement of non-motorized treadmill in their room) following in-patient gynecologic surgery.
We will approach all women undergoing gynecologic procedures that are expected to ambulate within 12 hours of their operation and are anticipated to remain hospitalized at least 18 hours. Following confirmation of eligibility, we will enroll subjects either in the clinic when they are being consented for their gynecologic procedure or upon presentation to the hospital the day of their procedure. Randomization will occur at the completion of the gynecologic procedure when it has been confirmed by the primary surgeon that the patient is able to ambulate independently within 12 hours after completion of the procedure. At that time, participants will be randomized using opaque envelopes prepared by the study statistician in a 1:1 ratio to receive usual post-operative care or treadmill-augmented care.
All patients will have a pedometer placed on their person in the post-anesthesia recovery unit (PACU) which will be removed the day of their discharge. The primary outcome assessed will be number of steps taken in the 24 hour period prior to discharge as assessed by the electronic pedometer readings.
Pedometer will be placed on patients using a lanyard and pedometer clip in the recovery room. No participant will start ambulation without physician's clinical order. When the patient is ready for the first ambulation she will be accompanied by a nurse to sit up in a chair. Once the patient is able to ambulate herself she may ambulate in her room or in the hallway or if randomized to treadmill group she will be able to ambulate on the treadmill. She will be wearing her pedometer at all times until discharge from Loyola.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| goal-augmented post-operative care. | Active Comparator | Patients in this group will be given a goal number of steps to take on each post-operative day. |
|
| Usual care | No Intervention | routine post-operative ambulation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| goal-augmented post-operative care | Behavioral | Patients in the goal-augmented post-operative care group will be given a goal number of steps to take on each post-operative day following in-patient gynecologic surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Steps Taken in 24 Hours. | The primary outcome assessed was the number of steps taken in the 24 hour period prior to discharge as assessed by the electronic pedometer readings. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda Brubaker, M.D. | Loyola University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States | ||
| Gottlieb Memorial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23635615 | Derived | Liebermann M, Awad M, Dejong M, Rivard C, Sinacore J, Brubaker L. Ambulation of hospitalized gynecologic surgical patients: a randomized controlled trial. Obstet Gynecol. 2013 Mar;121(3):533-537. doi: 10.1097/AOG.0b013e318280d50a. |
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All Enrolled patients were randomized to a group. Those patients who were enrolled but not included in statistical analysis had their data lost due to lost pedometer.
This randomized controlled trial enrolled patients who were going to undergo gynecologic surgery were enrolled from 1/11-6/11 at Loyola University Medical Center .We approached adult (>18 years) English speaking women prior to undergoing major gynecologic surgery who were expected to have at least a 24-hour hospital stay post-operatively.
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| ID | Title | Description |
|---|---|---|
| FG000 | Goal-augmented Post-operative Care. | Patients in this group will be given a goal number of steps to take on each post-operative day. |
| FG001 | Usual Care | routine post-operative ambulation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Goal-augmented Post-operative Care. | Patients in this group will be given a goal number of steps to take on each post-operative day. |
| BG001 | Usual Care | routine post-operative ambulation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Steps Taken in 24 Hours. | The primary outcome assessed was the number of steps taken in the 24 hour period prior to discharge as assessed by the electronic pedometer readings. | The analysis is an intention to treat (ITT) analysis comprising all participants who were randomized. | Posted | Median | Full Range | Steps | 1 day |
|
During Hospitalization.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Goal-augmented Post-operative Care. | Patients in this group will be given a goal number of steps to take on each post-operative day. |
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Difficulty ensuring that encouragement was given, as we did not quantify the frequency of encouragement by the health care team. Loss of data due to loss of pedometers
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linda Brubaker | Loyola University Medical Center | 708-216-4033 | lbrubaker@lumc.edu |
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| Melrose Park |
| Illinois |
| 60160 |
| United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 0 |
| 69 |
| 0 |
| 69 |
| EG001 | Usual Care | routine post-operative ambulation | 0 | 77 | 0 | 77 |
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