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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Does Increased Mobility Assessed With 3D Motion Tracking Technology Lead to Early Post-Operative Recovery Among Patients Undergoing Oncologic Surgeries

Conditions
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Malignant Neoplasm

Intervention / Treatment
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* Other: Best Practice
* Other: Physical Activity
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm I (usual care)<br>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<br>* Receive standard of care<br>* Other names: standard therapy;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Arm II (additional mobility)<br>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<br>* Walk for minimum 30 minutes per day<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Mobility | 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. | Baseline up to 30 days post discharge | 
| Early Return of Bowel Motion | Days from operation to passing flatus and/or stool, treated as continuous measure | Up to 30 days after discharge | 
| Presence or Absence of Nausea and/or Vomiting | Presence or absence of nausea and/or vomiting, treated as a binary variable | Up to 30 days after discharge | 
| Presence or Absence of Chest Symptoms | Presence or absence of chest symptoms (cough, sputum, and ability of using incentive spirometry), treated as a binary variable | Up to 30 days after discharge | 
| Early Discharge From the Hospital | Days from operation until hospital discharge, treated as continuous variable | Up to 30 days after discharge | 
| Surgical Related Complications and Readmissions | Presence or absence of surgical complication (including readmission), treated as a binary variable | Up to 30 days after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of Joint Movement in Upper and Lower Joints of Body | 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. | Up to 30 days after discharge | 
| Post-surgical Complications | 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. | Up to 30 days post discharge | 
| Change in Exercise Habits Outside of the Hospital | Post study questionnaire . | Up to 3 months post discharge | 
| Application of Sensors in a Hospital Setting | Adequate application of sensors, treated as a categorical variable | Up to 3 months post discharge | 
| Mobility Quality of Life Questionnaire | The correlation between complication status and changes in mobility may be evaluated using a post study questionnaire. | Up to 3 months post discharge |