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Impact of Early Mobility on Post-Surgery Recovery in Patients Undergoing Genitourinary Surgeries

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ClinicalTrials.gov Identifier: NCT04000581
Recruitment Status : Recruiting
First Posted : June 27, 2019
Last Update Posted : June 27, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Brief Summary:
This trial studies the impact of early mobility tracked with a 3-dimensional (3D) motion tracking technology (XSENS) on post-surgery recovery in patients undergoing genitourinary surgeries. Xsens uses wireless measurements which could be used in clinical settings to objectively measure movement patterns (the joint range of movement and the distance of movement) during functional activities. Post-surgery mobility tracking may help doctors to identify the minimum required level of mobility after inpatient genitourinary surgeries to enhance early post-surgery recovery and decrease early post-surgery complications.

Condition or disease Intervention/treatment Phase
Genitourinary System Disorder Surgery Patient Other: Best Practice Other: Physical Activity Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To investigate objectively using evidence based randomized controlled trial the impact of early mobility (first day after the surgery) after any inpatient genitourinary procedures on early recovery of postoperative course.

II. Try to find out the minimum level of postoperative mobility that needed for early postoperative course recovery by objective assessment of range of movement for each participant using 3D motion tracking system (Xsens).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients walk one to two laps around the ward twice per day, and have mobility tracked with Xsens over 5-10 minutes, until discharge from hospital. Patients also mobilize (walk out of the bed) on first day post-surgery under supervision and assistant of attending nurse in the floor if the clinical situation allows.

ARM II: Patients walk for minimum 30 minutes per day and mobility is tracked with Xsens over 5-10 minutes up to discharge from hospital. Patients also mobilize (walk out of the bed) on first day post-surgery under supervision and assistant of attending nurse in the floor if the clinical situation allows.

After completion of study, patients are followed up for 30 days post discharge.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Does Increased Mobility Assessed With 3D Motion Tracking Technology Lead to Early Post-Operative Recovery Among Patients Undergoing Genitourinary Surgeries
Actual Study Start Date : May 31, 2019
Estimated Primary Completion Date : May 8, 2021
Estimated Study Completion Date : May 2022

Arm Intervention/treatment
Active Comparator: Arm I (usual care)
Patients walk one to two laps around the ward twice per day, and have mobility tracked with Xsens over 5-10 minutes, until discharge from hospital. Patients also mobilize (walk out of the bed) on first day post-surgery under supervision and assistant of attending nurse in the floor if the clinical situation allows.
Other: Best Practice
Receive standard of care
Other Names:
  • standard of care
  • standard therapy

Experimental: Arm II (additional mobility)
Patients walk for minimum 30 minutes per day and mobility is tracked with Xsens over 5-10 minutes up to discharge from hospital. Patients also mobilize (walk out of the bed) on first day post-surgery under supervision and assistant of attending nurse in the floor if the clinical situation allows.
Other: Physical Activity
Walk for minimum 30 minutes per day




Primary Outcome Measures :
  1. Changes in mobility [ Time Frame: Baseline up to 30 days post discharge ]
    Measures of mobility (i.e. range of movement), which are treated as continuous measures and will be summarized by group and time-point using the mean, median, and standard deviation.

  2. Early return of bowel motion (passing flatus and/or stool on which postoperative day) [ Time Frame: Up to 30 days after discharge ]
  3. Change in Nausea and vomiting [ Time Frame: Up to 30 days after discharge ]
    Daily assessment of gastro intestinal complications

  4. Changes in severity of chest symptoms (cough, sputum, and ability of using incentive spirometry) [ Time Frame: Up to 30 days after discharge ]
    Daily assessment of gastro intestinal complicaitons

  5. Early discharge from the hospital [ Time Frame: Up to 30 days after discharge ]
  6. surgical related complications and readmissions [ Time Frame: Up to 30 days after discharge ]

Secondary Outcome Measures :
  1. Range of joint movement in upper and lower joints of body [ Time Frame: Up to 30 days after discharge ]
    Will be measured using the 3 dimensional (3D) motion tracking system (Xsens), to identify the minimum required level of mobility for better early postoperative course recovery.

  2. Post-surgical complications [ Time Frame: Up to 30 days post discharge ]
    The complication status (present/absent) and grades will be summarized by group and compared using Fisher?s exact test or the chi-square test, as appropriate.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ambulant inpatient with a stay of >= 2 days after any inpatient genitourinary surgery
  • Eastern Cooperative Oncology Group (ECOG) scale of performance status of less than 3
  • American Society of Anesthesiologist score (ASA) 3 or less
  • Participants who do not engage in regular exercise regimen before the surgery (other than regular occupational physical therapy)
  • Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

  • Patients with altered mental status
  • Patients with psychiatric illness
  • ECOG scale performance status 3 or more
  • ASA score of 4
  • Participants who engage in regular exercise regimen before surgery (at least one session per week)
  • Patients with restricted movement due to other diseases
  • Patients who require continuous monitoring

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04000581


Locations
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United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Khurshid A. Guru    716-845-4155    Khurshid.Guru@roswellpark.org   
Principal Investigator: Khurshid A. Guru         
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Khurshid A Guru Roswell Park Cancer Institute

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Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT04000581     History of Changes
Other Study ID Numbers: I 80918
NCI-2019-03139 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 80918 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( U.S. NIH Grant/Contract )
First Posted: June 27, 2019    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes