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

Malignant Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04000581
• Other study ID #: I 80918
• Secondary ID: NCI-2019-03139I
• Status: Terminated
• Phase: N/A
• Start date: May 31, 2019
• Est. completion date: April 10, 2020

Study information

• Verified date: July 2022
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: April 10, 2020
• Est. primary completion date: April 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms

Intervention

Other:
• Best Practice
Receive standard of care
• Physical Activity
Walk for minimum 30 minutes per day
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Early Return of Bowel Motion	Days from operation to passing flatus and/or stool, treated as continuous measure	Up to 30 days after discharge
Primary	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
Primary	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
Primary	Early Discharge From the Hospital	Days from operation until hospital discharge, treated as continuous variable	Up to 30 days after discharge
Primary	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	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
Secondary	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
Secondary	Change in Exercise Habits Outside of the Hospital	Post study questionnaire .	Up to 3 months post discharge
Secondary	Application of Sensors in a Hospital Setting	Adequate application of sensors, treated as a categorical variable	Up to 3 months post discharge
Secondary	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