Clinical trial NCT04000581: Impact of Early Mobility on Post-Surgery Recovery in Patients Undergoing Oncologic Surgeries
Official title: Does Increased Mobility Assessed With 3D Motion Tracking Technology Lead to Early Post-Operative Recovery Among Patients Undergoing Oncologic Surgeries
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Malignant Neoplasm
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2019-06-27
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Mobility
timeFrame: Baseline up to 30 days post discharge
measure: Early Return of Bowel Motion
timeFrame: Up to 30 days after discharge
measure: Presence or Absence of Nausea and/or Vomiting
timeFrame: Up to 30 days after discharge
measure: Presence or Absence of Chest Symptoms
timeFrame: Up to 30 days after discharge
measure: Early Discharge From the Hospital
timeFrame: Up to 30 days after discharge
measure: Surgical Related Complications and Readmissions
timeFrame: Up to 30 days after discharge
Secondary outcomes:
measure: Range of Joint Movement in Upper and Lower Joints of Body
timeFrame: Up to 30 days after discharge
measure: Post-surgical Complications
timeFrame: Up to 30 days post discharge
measure: Change in Exercise Habits Outside of the Hospital
timeFrame: Up to 3 months post discharge
measure: Application of Sensors in a Hospital Setting
timeFrame: Up to 3 months post discharge
measure: Mobility Quality of Life Questionnaire
timeFrame: Up to 3 months post discharge
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Khurshid A Guru
role: PRINCIPAL_INVESTIGATOR
References: