Impact of Early Mobility on Post-Surgery Recovery in Patients Undergoing Oncologic Surgeries
- Conditions
- Malignant Neoplasm
- Interventions
- Other: Best PracticeOther: Physical ActivityOther: 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
- 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
- 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
Group Intervention Description Arm I (usual care) Questionnaire Administration 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 (additional mobility) Questionnaire Administration 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. Arm I (usual care) Best Practice 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 (additional mobility) Physical Activity 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.
- Primary Outcome Measures
Name Time Method Changes in Mobility Baseline 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 Motion Up to 30 days after discharge Days from operation to passing flatus and/or stool, treated as continuous measure
Presence or Absence of Chest Symptoms Up 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 Readmissions Up to 30 days after discharge Presence or absence of surgical complication (including readmission), treated as a binary variable
Early Discharge From the Hospital Up to 30 days after discharge Days from operation until hospital discharge, treated as continuous variable
Presence or Absence of Nausea and/or Vomiting Up to 30 days after discharge Presence or absence of nausea and/or vomiting, treated as a binary variable
- Secondary Outcome Measures
Name Time Method Mobility Quality of Life Questionnaire Up to 3 months post discharge The correlation between complication status and changes in mobility may be evaluated using a post study questionnaire.
Post-surgical Complications 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.
Application of Sensors in a Hospital Setting Up to 3 months post discharge Adequate application of sensors, treated as a categorical variable
Range of Joint Movement in Upper and Lower Joints of Body 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.
Change in Exercise Habits Outside of the Hospital Up to 3 months post discharge Post study questionnaire .
Trial Locations
- Locations (1)
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States