External Causes of Morbidity and MortalityPOWERNCT01254851
Post Operative Walking Enhancements for Recovery (POWER) Trial
A study testing goal-augmented post-operative care in people with External Causes of Morbidity and Mortality, run by Loyola University at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- External Causes of Morbidity and Mortality
- What is being tested?
- goal-augmented post-operative care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2010to Jun 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Independent ambulation pre-operatively
- Undergoing gynecologic procedure
- Expected to ambulate within 12 hours of their procedure
Who cannot join
- Children under the age of 18
- Inability to ambulate independently prior to their surgery
- Primary surgeon does not want patient to ambulate within 12 hours of procedure
- English is not the primary language spoken by the patient
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Loyola University Medical Center
Maywood, Illinois, 60153
Gottlieb Memorial Hospital
Melrose Park, Illinois, 60160
About this study
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.
Read the detailed description
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.
- Being tested
- goal-augmented post-operative care
- Keywords
- discharge criteria, gynecologic surgery, post-op ambulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
goal-augmented post-operative careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: goal-augmented post-operative care |
| Usual care | No intervention | routine post-operative ambulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2010 (estimated)
- Study startOct 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for External Causes of Morbidity and MortalityStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Brubaker, Loyola University
- Investigators
- Linda Brubaker, M.D., Principal investigator, Loyola University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01254851
- Sponsor's protocol ID
- 203031
- Acronym
- POWER
- Status last verified
- Jun 2015
- First submitted
- 3 Dec 2010
- Last updated
- 8 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 23635615
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Operative Walking Enhancements for Recovery (POWER) Trial
- ClinicalTrials.gov ID
- NCT01254851
- Acronym / sponsor ID
- POWER / 203031
- Keywords
- discharge criteria, gynecologic surgery, post-op ambulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 7 Dec 2010 (estimated)
- Results
- Posted 8 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| goal-augmented post-operative care. | Active comparator | Behavioral: goal-augmented post-operative carePatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Independent ambulation pre-operatively
- Undergoing gynecologic procedure
- Expected to ambulate within 12 hours of their procedure
Key exclusion criteria (4 listed)
- Children under the age of 18
- Inability to ambulate independently prior to their surgery
- Primary surgeon does not want patient to ambulate within 12 hours of procedure
- English is not the primary language spoken by the patient
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 |
|---|---|---|
| goal-augmented post-operative carePatients 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. | Behavioural | goal-augmented post-operative care. |
Primary outcome
Number of Steps Taken in 24 Hours.
Time frame: 1 day
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23635615Liebermann 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.
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. This study is not recruiting at the moment.
Linda Brubaker, M.D. principal investigator
Loyola University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing goal-augmented post-operative care in people with External Causes of Morbidity and Mortality, run by Loyola University at 2 sites in United States.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 8 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 8 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Steps Taken in 24 Hours. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01254851, which also lists 1 linked publication.
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 8 Jul 2015.