MedPath

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

Not Applicable
Terminated
Conditions
Malignant Neoplasm
Interventions
Other: Best Practice
Other: Physical Activity
Other: Questionnaire Administration
Registration Number
NCT04000581
Lead Sponsor
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 oncologic 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 oncologic surgeries to enhance early post-surgery recovery and decrease early post-surgery complications.

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 oncologic 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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
17
Inclusion Criteria
  • Ambulant inpatient with a stay of >= 2 days after any inpatient oncologic 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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Arm I (usual care)Questionnaire AdministrationPatients 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 (additional mobility)Questionnaire AdministrationPatients 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.
Arm I (usual care)Best PracticePatients 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 (additional mobility)Physical ActivityPatients 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.
Primary Outcome Measures
NameTimeMethod
Changes in MobilityBaseline up to 30 days post discharge

changes in mobility (as measured by average velocity of pelvis) from baseline to discharge are compared between groups using a one-sided, two-sample t-test.

Early Return of Bowel MotionUp to 30 days after discharge

Days from operation to passing flatus and/or stool, treated as continuous measure

Presence or Absence of Chest SymptomsUp to 30 days after discharge

Presence or absence of chest symptoms (cough, sputum, and ability of using incentive spirometry), treated as a binary variable

Surgical Related Complications and ReadmissionsUp to 30 days after discharge

Presence or absence of surgical complication (including readmission), treated as a binary variable

Early Discharge From the HospitalUp to 30 days after discharge

Days from operation until hospital discharge, treated as continuous variable

Presence or Absence of Nausea and/or VomitingUp to 30 days after discharge

Presence or absence of nausea and/or vomiting, treated as a binary variable

Secondary Outcome Measures
NameTimeMethod
Mobility Quality of Life QuestionnaireUp to 3 months post discharge

The correlation between complication status and changes in mobility may be evaluated using a post study questionnaire.

Post-surgical ComplicationsUp 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.

Application of Sensors in a Hospital SettingUp to 3 months post discharge

Adequate application of sensors, treated as a categorical variable

Range of Joint Movement in Upper and Lower Joints of BodyUp 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.

Change in Exercise Habits Outside of the HospitalUp to 3 months post discharge

Post study questionnaire .

Trial Locations

Locations (1)

Roswell Park Cancer Institute

🇺🇸

Buffalo, New York, United States

© Copyright 2025. All Rights Reserved by MedPath