Post Operative Walking Enhancements for Recovery (POWER) Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Linda Brubaker, Loyola University
ClinicalTrials.gov Identifier:
NCT01254851
First received: December 3, 2010
Last updated: June 15, 2015
Last verified: June 2015
Results First Received: April 24, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: External Causes of Morbidity and Mortality
Intervention: Behavioral: goal-augmented post-operative care

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Goal-augmented Post-operative Care. Patients in this group will be given a goal number of steps to take on each post-operative day.
Usual Care routine post-operative ambulation

Participant Flow:   Overall Study
    Goal-augmented Post-operative Care.     Usual Care  
STARTED     69     77  
COMPLETED     61     68  
NOT COMPLETED     8     9  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Goal-augmented Post-operative Care. Patients in this group will be given a goal number of steps to take on each post-operative day.
Usual Care routine post-operative ambulation
Total Total of all reporting groups

Baseline Measures
    Goal-augmented Post-operative Care.     Usual Care     Total  
Number of Participants  
[units: participants]
  69     77     146  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     53     61     114  
>=65 years     16     16     32  
Age  
[units: years]
Mean (Standard Deviation)
  56.1  (11.1)     53.9  (13.27)     54.98  (12.3)  
Gender  
[units: participants]
     
Female     69     77     146  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     69     77     146  



  Outcome Measures

1.  Primary:   Number of Steps Taken in 24 Hours.   [ Time Frame: 1 day ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Linda Brubaker
Organization: Loyola University Medical Center
phone: 708-216-4033
e-mail: lbrubaker@lumc.edu


No publications provided by Loyola University

Publications automatically indexed to this study:

Responsible Party: Linda Brubaker, Loyola University
ClinicalTrials.gov Identifier: NCT01254851     History of Changes
Other Study ID Numbers: 203031
Study First Received: December 3, 2010
Results First Received: April 24, 2012
Last Updated: June 15, 2015
Health Authority: United States: Institutional Review Board