- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04000581
Impact of Early Mobility on Post-Surgery Recovery in Patients Undergoing Oncologic Surgeries
Does Increased Mobility Assessed With 3D Motion Tracking Technology Lead to Early Post-Operative Recovery Among Patients Undergoing Oncologic Surgeries
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14263
- Roswell Park Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm I (usual care)
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.
|
Ancillary studies
Receive standard of care
Other Names:
|
Experimental: Arm II (additional mobility)
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.
|
Ancillary studies
Walk for minimum 30 minutes per day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Mobility
Time Frame: 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.
|
Baseline up to 30 days post discharge
|
Early Return of Bowel Motion
Time Frame: Up to 30 days after discharge
|
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
Time Frame: Up to 30 days after discharge
|
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
Time Frame: 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
|
Up to 30 days after discharge
|
Early Discharge From the Hospital
Time Frame: Up to 30 days after discharge
|
Days from operation until hospital discharge, treated as continuous variable
|
Up to 30 days after discharge
|
Surgical Related Complications and Readmissions
Time Frame: Up to 30 days after discharge
|
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
Time Frame: 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.
|
Up to 30 days after discharge
|
Post-surgical Complications
Time Frame: 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.
|
Up to 30 days post discharge
|
Change in Exercise Habits Outside of the Hospital
Time Frame: Up to 3 months post discharge
|
Post study questionnaire .
|
Up to 3 months post discharge
|
Application of Sensors in a Hospital Setting
Time Frame: Up to 3 months post discharge
|
Adequate application of sensors, treated as a categorical variable
|
Up to 3 months post discharge
|
Mobility Quality of Life Questionnaire
Time Frame: Up to 3 months post discharge
|
The correlation between complication status and changes in mobility may be evaluated using a post study questionnaire.
|
Up to 3 months post discharge
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Khurshid A Guru, Roswell Park Cancer Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- I 80918 (Other Identifier: Roswell Park Cancer Institute)
- NCI-2019-03139 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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