Post Operative Walking Enhancements for Recovery (POWER) Trial
This study is ongoing, but not recruiting participants.
Sponsor:
Loyola University
Information provided by (Responsible Party):
Loyola University
ClinicalTrials.gov Identifier:
NCT01254851
First received: December 3, 2010
Last updated: September 13, 2011
Last verified: September 2011
| Tracking Information | |||||
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| First Received Date ICMJE | December 3, 2010 | ||||
| Last Updated Date | September 13, 2011 | ||||
| Start Date ICMJE | October 2010 | ||||
| Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Number of steps taken in twentyfour hours. [ Time Frame: 1 day ] [ Designated as safety issue: No ] 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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01254851 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Post Operative Walking Enhancements for Recovery (POWER) Trial | ||||
| Official Title ICMJE | Post Operative Walking Enhancements for Recovery (POWER) Trial | ||||
| Brief 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Postoperative Morbidity and Mortality | ||||
| Intervention ICMJE | Behavioral: goal-augmented post-operative care
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. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 120 | ||||
| Estimated Completion Date | April 2012 | ||||
| Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01254851 | ||||
| Other Study ID Numbers ICMJE | 203031 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Loyola University | ||||
| Study Sponsor ICMJE | Loyola University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Loyola University | ||||
| Verification Date | September 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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