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

Roswell Park Comprehensive Cancer Center

Status: Terminated

Conditions: Malignant Neoplasm

Treatments: Other: Questionnaire Administration; Other: Physical Activity; Other: Best Practice

Study type: Interventional

Funder types: Other

Identifiers

NCT04000581

I 80918 (Other Identifier)

NCI-2019-03139 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

Arm I (usual care)

Active Comparator group

Description:

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.

Treatment:

Other: Best Practice

Other: Questionnaire Administration

Arm II (additional mobility)

Experimental group

Description:

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.

Treatment:

Other: Physical Activity

Other: Questionnaire Administration